Early Pregnancy

Development and Validation of a Pregnancy
Symptoms Inventory

by

Kaye Katie Frances Foxcroft
RN, RM

A thesis submitted in partial fulfilment of the requirements for the degree of

Masters of Applied Science- Research

School of Human Movements Faculty of Health

Queensland University of Technology

2010
Development and Validation of a Pregnancy Symptoms Inventory

i
Abstract
BACKGROUND. Physical symptoms are common in pregnancy and are
predominantly associated with normal physiological changes. These
symptoms have a social and economic cost, leading to absenteeism from
work and additional medical interventions. There is currently no simple
method for identifying common pregnancy related problems in the antenatal
period. A validated tool, for use by pregnancy care providers would be useful.
AIM: The aim of the project was to develop and validate a Pregnancy
Symptoms Inventory for use by healthcare professionals (HCPs).
METHODS: A list of symptoms was generated via expert consultation with
midwives and obstetrician gynaecologists. Focus groups were conducted
with pregnant women in their first, second or third trimester. The inventory
was then tested for face validity and piloted for readability and
comprehension. For test-re-test reliability, it was administered to the same
women 2 to 3 days apart. Finally, outpatient midwives trialled the inventory
for 1 month and rated its usefulness on a 10cm visual analogue scale (VAS).
The number of referrals to other health care professionals was recorded
during this month.
RESULTS: Expert consultation and focus group discussions led to the
generation of a 41-item inventory. Following face validity and readability
testing, several items were modified. Individual item test re-test reliability was
between .51 to 1 with the majority (34 items) scoring 0.70. During the
testing phase, 211 surveys were collected in the 1 month trial. Tiredness
ii
(45.5%), poor sleep (27.5%) back pain (19.5%) and nausea (12.6%) were
experienced often. Among the women surveyed, 16.2% claimed to
sometimes or often be incontinent. Referrals to the incontinence nurse
increased > 8 fold during the study period. The median rating by midwives of
the usefulness of the inventory was 8.4 (range 0.9 to 10).
CONCLUSIONS: The Pregnancy Symptoms Inventory (PSI) was well
accepted by women in the 1 month trial and may be a useful tool for
pregnancy care providers and aids clinicians in early detection and
subsequent treatment of symptoms. It shows promise for use in the research
community for assessing the impact of lifestyle intervention in pregnancy.

iii
Keywords
Pregnancy Symptoms
Inventory
Survey
Questionnaire
Checklist
iv
Table of contents
Abstract ...................................................................................................i
Keywords............................................................................................... iii
Table of contents...................................................................................iv
List of figures ........................................................................................ vii
List of tables ........................................................................................ viii
List of supplementary materials.............................................................ix
Abbreviations..........................................................................................x
1 BACKGROUND......................................................................... 1
1.1 Research Aims........................................................................... 2
1.2 Research Questions .................................................................. 2
1.3 Hypotheses................................................................................ 3
2 LITERATURE REVIEW............................................................. 4
2.1 Nausea and Vomiting................................................................. 4
2.2 Fatigue....................................................................................... 5
2.3 Back pain ................................................................................... 6
2.4 Incontinence............................................................................... 7
2.5 Sleep Disturbances.................................................................... 8
2.6 Psychosocial Variables .............................................................. 9
2.7 Existing instruments................................................................. 10
3 APPROACH TO THE DEVELOPMENT AND TESTING OF THE
INVENTORY............................................................................ 15
3.1 Development............................................................................ 15
3.2 Interviews................................................................................. 15
3.3 Focus Groups .......................................................................... 16
3.3.1 Advantages.............................................................................. 17
3.3.2 Limitations................................................................................ 17
3.4 Designing Instruments ............................................................. 17
3.5 Testing ..................................................................................... 18
4 METHODS............................................................................... 20
4.1 Design...................................................................................... 20
v
4.2 Aims ......................................................................................... 20
4.3 Participants and setting............................................................ 20
4.4 Procedure................................................................................. 20
4.4.1 Phase 1 (Expert consultation) .................................................. 21
4.4.2 Phase 2 (Focus groups) ........................................................... 21
4.4.3 Reconciliation of Data .............................................................. 23
4.4.4 Phase 3 (development and testing).......................................... 23
4.4.4.1 Face Validity............................................................................. 23
4.4.4.2 Test re-test ............................................................................... 25
4.4.4.3 Midwives perception of the usefulness of the inventory ........... 26
4.4.4.4 Practical use (Administration of the Inventory) ......................... 27
4.5 Ethical Considerations.............................................................. 28
5 ANALYSIS............................................................................... 30
5.1 Development of inventory:........................................................ 30
5.1.1 Phase 1: Expert consultation.................................................... 30
5.1.2 Phase 2: Focus groups ............................................................ 30
5.1.3 Phase 3: Validating and testing the Inventory .......................... 30
5.1.3.1 Face validity ............................................................................. 30
5.1.3.2 Test re-test ............................................................................... 31
5.1.3.3 Usefulness of the inventory ...................................................... 31
5.1.3.4 Practical use............................................................................. 31
6 RESULTS................................................................................. 33
6.1 Phase 1 (Expert healthcare professionals consultation)........... 33
6.2 Phase 2 (Focus Groups) .......................................................... 34
6.3 Phase 3 Validating and testing the inventory............................ 34
6.3.1 Face validity (midwives) ........................................................... 34
6.3.2 Face validity (Comprehension and readability of the inventory by
pregnant women) ..................................................................... 35
6.3.3 Test re-test ............................................................................... 35
6.3.4 Usefulness of the inventory ...................................................... 37
6.3.5 Practical use............................................................................. 38
6.3.5.1 Characteristics of Respondents................................................ 38
6.3.5.2 Frequency of symptoms ........................................................... 39
vi
6.3.5.3 Relationships between symptoms and referrals....................... 43
7 DISCUSSION........................................................................... 46
7.1 Questionnaire Development..................................................... 46
7.2 Hypotheses.............................................................................. 52
7.3 Midwives Attitudes and Practice Change................................. 53
7.4 Limitations................................................................................ 54
7.5 Implications for Practice........................................................... 56
7.6 Implications for Pregnant Women............................................ 56
7.7 Recommendations for Research.............................................. 57
7.8 Conclusions ............................................................................. 58
References ........................................................................................ 101
vii
List of figures
Figure 1 Framework for the development and testing of the PSI .. 19
Figure 2 Incontinence referrals from Maternity Outpatients.......... 45
viii
List of tables
Table 1 Comprehension and readability of inventory (n=10)....... 25
Table 2 Symptoms identified by healthcare professionals (e) and
women (f) ....................................................................... 33
Table 3 Test re-test results for 23 women in Maternity Outpatients36
Table 4 Visual Analogue Scale and if PSI prompted referral and
associated comments (Midwife Survey) ......................... 38
Table 5 Demographics of surveyed women (n=211 unless otherwise
stated) ............................................................................ 39
Table 6 Prevalence of self reported often or sometimes experienced
pregnancy symptoms as a proportion of valid responses.41
Table 7 Prevalence of self-reported limitation as a proportion of those
women who reported experiencing the symptom. .......... 42
Table 8 Statistically significant relationships between symptoms and
referrals from the inventory (n=211) ............................... 43
Table 9 Proportion of referrals by midwives documented on
Pregnancy Symptom Inventory (n = 211)....................... 44
ix
List of supplementary materials
Appendix 1 Prevention of Gestational Diabetes ................................ 60
Appendix 2 Exercise in obese pregnant women: The role of social
factors, lifestyle and pregnancy symptoms..................... 64
Appendix 3 Letter of Invitation.......................................................... 88
Appendix 4 Survey of Midwives who used the PSI............................ 89
Appendix 5 Inventory completed by women included in the study .... 91
Appendix 6 Permission from the Ethics Committee........................... 94
Appendix 7 Participation Information and Consent Form.................. 97
x
Abbreviations
PSI Pregnancy Symptoms Inventory
RBWH Royal Brisbane and Womens Hospital
HCP Healthcare Professional
HCW Healthcare Worker
VAS Visual Analogue Scale
ADLs Activities of daily living
MOPD Maternity Outpatient Department
xi
Authorship
The work contained in this thesis has not been previously submitted to meet
requirements for an award at this or any other higher education institution. To
the best of my knowledge and belief, the thesis contains no material
previously published or written by another person except where due
reference is made.

Signature

Date

1
1 BACKGROUND
Physical symptoms are common in pregnancy and are predominantly
associated with normal physiological changes that occur during this time.
Much of the literature reports on one or two specific symptoms and does not
look at pregnancy in its entirety (Attard et al., 2002; Behrenz & Monga, 1999).
To the best of the authors knowledge there is currently no available
pregnancy specific symptoms inventory. There are reasons to believe that
such an instrument is needed. Designing a pregnancy symptoms inventory,
which acts as a risk assessment tool, assessing not only the prevalence of
symptoms but the frequency and severity, may be helpful in assessing which
women would benefit from early detection and treatment of pregnancy
symptoms. These symptoms have a social and economic cost as they are
responsible for absenteeism from work and additional medical interventions
(Doran et al., 2001; Noren et al., 1997). The basis of this study is an
assumption that early detection and treatment of symptoms will reduce the
severity of their impact on womens quality of life and their activities of daily
living such as ability to work. In turn, this may minimize the impact to the
health care system and the Australian economy.
This need was confirmed in an earlier study that this author project managed
at The Royal Brisbane and Womens Hospital (RBWH). This was an
investigation of the feasibility issues for an exercise intervention in obese
pregnant women that found a number of issues, which prevented women
from fully participating in their exercise intervention (Callaway et al., 2010).
The investigators suggested that an instrument, which could measure the
2
impact of pregnancy symptoms and other sociodemographic variables, would
have been useful in this lifestyle intervention program. See Appendix 1.
Subsequently a secondary analysis of the data revealed that women who
reported no nausea and vomiting and who had no lower back pain were
those women who were most likely to have exercised in early pregnancy
(Foxcroft et al., 2010). See Appendix 2.
The current study was conducted at The Royal Brisbane and Womens
Hospital (RBWH), a large tertiary referral hospital caring for many of the
States more complicated pregnancies. Approximately 5000 pregnant women
per year attend the hospitals busy Maternity Outpatient department. This
high throughput impacts on the time available for staff to fully explore issues
the pregnant woman may wish to discuss. Development of a Pregnancy
Symptoms Inventory, which could be completed whilst waiting to be seen by
their midwife or doctor, may aid in pinpointing particular problems the woman
is experiencing with her pregnancy. Some symptoms, such as incontinence,
may be embarrassing for the woman to talk about face to face. The ability to
fill in a checklist would be an easier way to broach the subject.
1.1 Research Aims
The aim of the project was to develop and validate a Pregnancy Symptoms
Inventory for use by healthcare professionals (HCPs).
1.2 Research Questions
a) What pregnancy signs and symptoms are reported by healthcare
professionals (HCPs)?
b) Are additional signs and symptoms reported by patients?
3
c) Can these signs and symptoms be combined in a Pregnancy Symptoms
Inventory that would grade severity and be useful to health workers who
provide care to pregnant women?
d) Does the use of a Pregnancy Symptoms Inventory result in an increase in
referrals to appropriate service providers?
1.3 Hypotheses
That a Pregnancy Symptoms Inventory, when used as part of a standard
prenatal visit, will be useful to healthcare professionals (HCPs).
That a Pregnancy Symptoms Inventory will identify, and be able to
discriminate between mild conditions and those requiring intervention.

4
2 LITERATURE REVIEW
A review of the available literature identified a variety of pregnancy
symptoms. Thirty eight discrete symptoms have been described (Zib et al.,
1999), with five being reported most frequently. These are: frequency of
micturition (passing urine), fatigue, pelvic pressure, insomnia and lower
backache. However, pregnancy symptoms are not always experienced in
isolation. There are many studies that have investigated a small number of
pregnancy symptoms (Jomeen et al., 2005; OBrien & Naber, 1992; Smith et
al., 2006) although the interaction of symptoms, such as back and pelvic pain
causing sleep disturbances or sleep disturbances causing fatigue are less
well explored. Psychosocial variables also impacts on the variance in the
prevalence and frequency of a variety of pregnancy symptoms (Rodriguez et
al., 2001).
The following review focuses on the most common symptoms experienced
by women during pregnancy to gain an understanding of the level and quality
of research in these areas.
2.1 Nausea and Vomiting
Approximately 70% of all pregnant women experience nausea and vomiting
to some degree in their first trimester (Jomeen et al., 2005). For 50% of these
women, this will resolve by the 14
th
week of their pregnancy. However it was
not until gestational week 22 that nausea had resolved in 90% of affected
women in a prospective study of 160 women using daily self-recording of
symptoms and the McGill Nausea Questionnaire (Lacroix et al., 2000). This
same study demonstrated that nausea and vomiting experienced by pregnant
5
women was comparable to what is thought to be the worst nausea, that of
cancer chemotherapy (Lacroix et al., 2000).
The term morning sickness can be misleading as many studies have shown
that symptoms can happen at anytime of the day or night (Dilorio et al., 1992;
Gadsby, 1994; Lacroix et al., 2000; van Lier et al., 1993). One study reported
29% of women had symptoms severe enough to alter their daily activities
(OBrien & Naber, 1992). It has been reported that women who experience
frequent nausea and vomiting feel more depressed than those without these
symptoms this positive correlation was seen in a study of 113 participants
by (Chou et al., 2003) and supported by findings from (Reeves et al., 1991).
Another study of women showed the more severe the vomiting or the
retching in early pregnancy, the longer the symptoms lasted and this
increase in vomiting was associated with decreased infant birth weight (Zhou
et al., 1999). Zhous study also found there are effective and commonly used
palliative measures which can be suggested by the midwife or doctor
including rest, eating carbohydrates and drinking carbonated drinks -of note
20% of participants had not tried these measures indicating that suggesting
these methods to women with severe vomiting may be beneficial.
2.2 Fatigue
Studies report that the most common barrier to exercise in pregnancy is
fatigue (Symons Downs & Ulbrecht, 2006). In a study of 476 Scandinavian
nulliparous women, fatigue was experienced by over 90% of the sample
throughout the pregnancy (Rodriguez et al., 2001). In Behrenz and Mongas
(1999) study they showed that pregnant women experienced significantly
6
greater fatigue than a similar non-pregnant group of women. Some studies
have shown that fatigue increased in the third trimester (Elek et al., 1997;
Fawcett & York, 1986) whilst other studies showed a greater level of fatigue
in the first trimester (Affonso et al., 1990; Paarlberg et al., 1996).
Fatigue has been shown to be an important factor associated with antenatal
morbidity (Luke et al., 1999). In one study of 633 women who were 20-36
weeks pregnant, the prevalence of fatigue was 94.6% and their fatigue
scores were significantly associated with caesarian deliveries. Interestingly
women who did not work outside the home in this study had significantly
higher fatigue scores than women who did sedentary work (Chien & Ko,
2003). However, the study did not speculate or provide data to explain this
finding, subsequently, it may be an are for future research
Many women suffer from a lower haemoglobin during pregnancy and this
may lead to feelings of fatigue which can be helped with the aid of an iron
supplement (Beischer & Mackay, 1988) . There has also been research
which indicates that nausea and vomiting are correlated with fatigue
(FitzGerald, 1984; van Lier et al., 1993) and this finding supports the notion
that many pregnancy symptoms should not be looked at in isolation.
2.3 Back pain
Low back pain and pelvic pain are common among pregnant women with
reported rates between 5575% (Kristiansson et al., 1996; Mogren &
Pohjanen, 2005; Orvieto et al, 1994; Pool-Goudzwaard, 2005). One study
found a significantly greater occurrence of pelvic floor dysfunction in women
suffering pregnancy-related lower back pain or pelvic pain. This finding is
7
supported by Smith (2006) who found a strong association between
incontinence and back pain (Smith et al., 2006). The average sick leave due
to back pain in pregnancy is seven weeks in Sweden (Noren et al., 1997);
this equates to substantial economic cost. Back pain in pregnancy is
treatable. Women with back pain may be referred to a physiotherapist for
core stability training or water gymnastics as there is good evidence that
these strategies can reduce back pain in pregnancy (Pennick & Young, 2007)
2.4 Incontinence
Urinary incontinence is a common complaint in pregnancy (Eliasson et al.,
2005). In a study of 665 primiparous women, the incidence of urinary leakage
was 62%. A substantial number of women complain that urinary symptoms
affect their quality of life (QOL) to some degree. In one study, which used the
International Prostate Symptom Score (IPSS), approximately half of the
pregnant women reported that they were mostly dissatisfied because of their
urinary symptoms. The instrument is not gender specific but simply aims to
quantify the severity of symptoms and the impact of urinary symptoms on
their quality of life (Aslan et al., 2003).
The total annual cost of urinary incontinence in Australia has been estimated
at $710 million (Doran et al., 2001). There is strong evidence that pelvic floor
exercises performed during and after pregnancy can prevent urinary
incontinence. One Australian study that investigated over 30,000 women in
differing age groups found that one in three mid-age and older women
experience leaking urine and that it was significantly associated with parity.
This study suggested, as less than half of these women had sought help, that
it is an issue which should be brought up during their antenatal care (Chiarelli
8
& Brown, 1999). Available evidence indicates, because incontinence is a
somewhat embarrassing subject socially, that patients and medical
practitioners alike are reticent about discussing it (Chiarelli, 2004).
The pregnancy symptoms inventory could be used to flag such problems;
patients who are uncomfortable bringing up the topic may find it easier to
tick a box, to alert their midwife or doctor that they are experiencing
problems in this area.
2.5 Sleep Disturbances
Sleep disturbances are common in pregnancy (Mindell & Jacobson, 2000;
Sahota et al., 2003; Santiago et al., 2001) and are thought to be caused by a
number of factors including physiological, hormonal, and physical changes
associated with pregnancy (Santiago et al., 2001). Sleep disturbances are
most prevalent in the third trimester (Sahota et al., 2003). One study showed
an increase in specific awakenings of 63% in the first trimester, 80% in the
second trimester and 84% in the third trimester (Lopes et al., 2004). One
explanation for the increase in maternal wakefulness in the third trimester
was the correlation between foetal activity and the increased number of
maternal awakenings during sleep (Worth et al., 2002).
Sleep disturbances range from insomnia and excessive nocturnal
awakenings, to restless leg syndrome and snoring (Pien & Schwab, 2004;
Sahota et al., 2003). Decreased haemoglobin levels and deficits of iron and
vitamins were found to be risk factors for restless leg syndrome (Tun et al.,
2007). Other factors such as increased BMI and the development of
preeclampsia may contribute to sleep disturbances such as snoring (Sahota
9
et al., 2003). Some of these symptoms for example incontinence (Chiarelli,
2004) and back pain (Pennick & Young, 2007) can be minimised by early
intervention.
2.6 Psychosocial Variables
Many symptoms during pregnancy can impact on the health and well being of
both mother and baby and may be exacerbated by emotional issues. One
study showed that stress not only contributed to prevalence and frequency of
concurrent symptoms but also predicted symptoms for up to 16 weeks later
and was more predictive than medical risk, smoking or weight gain
(Rodriguez et al., 2001). In another study depressive symptoms were
associated with physical complaints in early pregnancy but the author stated
that it was unclear whether depressive symptoms and social support
preceded the physical symptoms or resulted from them (Chou et al., 2003).
Other studies have reported women in early pregnancy with depressive
symptoms have poor health-related quality of life and suggest that early
identification and management may improve their sense of well being
(Nicholson et al., 2006).
Although pregnancy symptoms have been reported by numerous authors,
questions and data collection methods vary considerably between studies.
This may be due to the lack of a standardised tool for reporting the frequency
and severity of pregnancy symptoms. Some of the tools used for this purpose
are discussed below.
10
2.7 Existing instruments
There are many health related questionnaires, surveys, checklists and
inventories designed to uncover particular health issues. Self- administered
questionnaires are the most practical, efficient, and inexpensive method of
obtaining patient-based information (Hajebrahimi et al., 2004).
The McGill Nausea Questionnaire was developed and evaluated by
(Melzack et al., 1985) in response to the need for a valid and reproducible
measure to evaluate therapies for nausea induced by cancer chemotherapy.
The questionnaire consists of three indexes of nausea, two quantitative and
one qualitative. The quantitative components consist of an overall nausea
index based on a scale 0 to 5 and a visual analogue scale. The qualitative
measure consisted of sets of verbal affective and other descriptors of
nausea, with each set ranked in order of severity (Lacroix et al., 2000). This
questionnaire has been found to be a sensitive measure of the nausea and
vomiting produced by chemotherapy drugs (Melzack et al., 1985). The McGill
Nausea Questionnaire takes 2 -3 minutes and was completed weekly.
However the overall nausea index was used for the detailed daily nausea
ratings in the Lacroix et al (2000) study of 160 women who provided daily
recordings of frequency, duration and severity of nausea and vomiting which
gave more in depth detail.
In another study looking at the severity of nausea and vomiting during
pregnancy the Rhodes Index of Nausea and Vomiting Form 2(INV2) was
used (Zhou et al., 1999). This is an 8-item, Likert-type, self report instrument
that measures degree and duration of nausea, vomiting and retching
(Rhodes et al., 1984). This 5 - point scale ranged from 1 (no symptoms) to 5
11
(severe symptoms). Although there are limitations to self report
questionnaires the reliability and validity of the instrument has been
supported in other studies (Zhou et al., 1999).
The Fatigue System Checklist (FSC) was first developed to measure
fatigue in Japanese industrial workers (Yoshitake, 1978) and was later
revised to measure fatigue in new mothers of full term infants (Milligan et al.,
1997). The FSC was scored as a total scale, comprising of 30 items with
(yes/no) responses and scored 0-30. A high FSC score indicates greater
fatigue. In Milligan et als study of 285 mothers the internal consistency was
0.82-0.95 at three time periods. Construct validity was shown by the positive
association between fatigue scores and depression, multiparity, infant
difficulty and less sleep at three time periods. Internal consistency of the FSC
was 0.89 as assessed by Cronbachs alpha (Chien & Ko, 2003).
The Pearson Bryars Fatigue Feeling Checklist (PBFFC) is a self
reported scale that measures fatigue at six times during the previous day;
starting with upon wakening and finishing with just before retiring.
Responses range from 1, extremely peppy to 10, ready to drop, total
scores range from 6-60. The reported coefficients of reproducibility of
individual items on the scale exceeded or approached the 0.90 acceptance
level, and the coefficient of scalability was 0.71 (van Lier et al., 1993).
In a 2002 review of five low back disability questionnaires the modified
Oswestry Disability Questionnaire, the Quebec Back Pain Disability
Scale, the Roland-Morris Disability Questionnaire, the Waddell
Disability Index, and the SF-36 Physical Functioning Scale (SF-36) were
12
compared in patients undergoing physical therapy for low back pain. The aim
of the study was to compare the reliability of the five low back pain disability
measurements in an ambulatory clinical population seeking physical therapy
for low back pain in hospital outpatient departments, community clinics, and
private practices. The review found that the measurements using the
modified Owestry Disability Questionnaire, the SF-36 Physical Functioning
Scale, and the Quebec Back Pain Disability Scale were the most reliable and
had sufficient width scale reliability to detect improvement or worsening in
most subjects. The reliability of measurements with the Waddell Disability
Index was moderate but the scale appeared to be insufficient to recommend
its use clinically. The Roland Morris Disability Questionnaire and the Role
Limitations Physical and Bodily Pain Scales of the SF-36 lacked sufficient
reliability and scale width for clinical use (Davidson & Keating, 2002).
The International Consultation on Incontinence Questionnaire short
form (ICIQ-SF) is a short questionnaire (five questions) proposed by the
World Health Organisation Consultation on Incontinence, with the aim of
providing an easy to use set of modules covering the assessment of urinary
incontinence severity and its impact on quality of life (Hajebrahimi et al.,
2004). The administration time is approximately 3.5 minutes (Abdel-Fattah et
al., 2007). This questionnaire was used in a study of 64 women consulting for
urinary incontinence. They were asked to complete the ICIQ-SF three times;
twice during the same visit, by self administration and physician interview,
and once at home approximately one week later. The study demonstrated
that information obtained through self administration at the office, at home, or
by the physician was not different (Hajebrahimi et al., 2004). The sensitivity,
13
validity and reliability of the ICIQ-SF have been confirmed in other studies, it
showed moderate correlation with the Kings Health questionnaire and Bristol
female lower urinary tract symptoms quality of life factor questionnaires
(Avery et al., 2004).
The Incontinence Bothersome Scale (IBS) was developed to see if a
simple visual analogue scale (VAS) which takes only a few seconds to
complete, can reliably assess the quality of life in women with urinary
incontinence (Abdel-Fattah et al., 2007). When compared to the Kings
Health Questionnaire (KHQ) which is a validated and reliable questionnaire
in urogynaecology research, results showed poor correlation between the
IBS and KHQ scores (Abdel-Fattah et al., 2007). The author of the study
concluded that it was difficult for the physician and the patients to summarize
all the adverse effects of urinary incontinence into a single score on the VAS
(Abdel-Fattah et al., 2007).
The Sleep and Health Questionnaire (SHQ) and the Epworth Sleepiness
Scale (ESS) are two methods of evaluating sleep disturbances. The SHQ
contains 16 questions grouped into five factors (functional impact of
sleepiness, self reported breathing disturbances, roommate-observed
breathing disturbances, driving impairment, and insomnia), which have been
useful in predicting sleep apnoea.
The ESS is a measure of daytime sleepiness. This self administered
questionnaire asks subjects to rate on a scale of 0 - 3 the chance they would
fall asleep or doze off in eight common situations in life, giving a total score
14
out of 24. Both these questionnaires are subjective assessments of
sleepiness form slightly different angles (Leung et al., 2005).
This overview of existing instruments demonstrates the complexity of
pregnancy symptoms and ways of measuring them. However, despite the
availability of many instruments, they all deal with only one pregnancy
problem. There is no instrument that evaluates all pregnancy symptoms at
the same time. Zibs 1999 study was an interviewer administered study
aimed at determining the nature and range of symptoms occurring in normal
pregnancy. This study however did not look at severity and affect the
symptoms had on the womans activities of daily living (ADLs).
One approach would be to combine the best of the discrete symptom
questionnaires into one tool. However, this would make any such
questionnaire too lengthy for any practical application. The other approach;
the one adopted here, is to develop a completely new instrument, one based
on investigating issues that women experience, using qualitative methods.
Any such instrument should incorporate degrees of severity to be useful to
clinicians. They should also be shown to be valid, reliable and acceptable to
clinicians.
15
3 APPROACH TO THE DEVELOPMENT AND
TESTING OF THE INVENTORY
3.1 Development
A check list or inventory has been defined as a type of informational job aid
used to reduce failure by compensating for potential limits of human memory
and attention (http://en.wikipedia.org/wiki/Checklist). It differs from scales or
indices, which use several related questions to measure one concept or
variable (Drewes, 2009). However, the development of an inventory follows
many of the same stages as those used in the development of most new
instruments; that is literature reviews, in-depth interviews and focus group
interviews. The literature review is an important first step, it provides
information about what is known and can be used to identify information
gaps. Interviews and focus group sessions are used to provide additional
information. They should include all relevant key stakeholders because it has
been shown that the beliefs may differ between groups or representatives of
groups (Maczka et al., 2009).
3.2 Interviews
Interviews can be conducted in an unstructured or structured way. Less
structured interviews may be useful in a preliminary survey , where the
purpose is to obtain information to help in the subsequent planning of a study
(Abramson & Abramson, 1999).However interviews are difficult to do well
and require considerable time and energy (Liamputtong & Ezzy, 2006).
16
3.3 Focus Groups
Focus groups are another method of collecting information and usually
consist of between 6-10 participants (Krueger, 1994).Multiple groups up to
fifty may be used however usually just a few are needed (Kitzinger,
1995).The number of focus groups is determined by the information which is
gathered, when no new themes are coming forward saturation has been
reached.
The aim is for a homogeneous group (similar age, gender, education, ethnic
background and life experiences) to capitalise on shared experiences whilst
still having some diversity in the group to get a cross section of opinion
(Ivanoff & Hultberg, 2006).
The environment needs to be trusting, non-judgemental and encourage self
disclosure. This enables people who are reluctant to express their views in a
one on one interview to feel more supported in a focus group. Participants
are chosen for their knowledge on the topic which often empowers them as
they feel like an expert on the topic. The facilitator has to be careful not to
lead the discussion or reinforce existing expectations and make it clear that
they are there to hear from the participants who should be discussing the
topic between the group members and not directly addressing the facilitator
(Sim, 1998). The facilitator also needs to be empathetic and have good
listening skills (Ivanoff & Hultberg, 2006) whilst striking a delicate balance
between involvement and too much involvement. It has been suggested no
more than 5%-10% of the transcript should be the words of the facilitator
(Hague, 1993) and that having a second researcher in the room is useful in
picking up any undue prompting (Sim, 1998).
17
3.3.1 Advantages
Focus groups allow for a greater spontaneity and are more economical than
one-on-one interviews. They provide a safe forum as participants dont
have to answer every question (Sim, 1998). Participants who cannot read or
write or who have other specific difficulties are not discriminated against
(Robinson, 1999; Sim, 1998). Focus groups may give participants support
and empower them by a sense of group membership. Kitzinger (1995) says
focus groups reach the parts that other methods cannot. This method of
data collection is sensitive to cultural variables and can identify shared and
common knowledge.
3.3.2 Limitations
Focus groups rely on group dynamics and are central to their success;
however, dominant articulate members of the group can suppress the less
self confident or less articulate group members from expressing alternate
view points (Kitzinger, 1995; Sim, 1998). Other limitations include the
compromised confidentiality of group members in a focus group; this could
mean if the topic is sensitive the participants may not want to reveal their
thoughts or personal backgrounds.
3.4 Designing Instruments
Items or questions generated through the development process may be
either open-ended or closed-ended and there are advantages and
disadvantages to both. The open-ended question gives the participant more
scope to report richer information than a discrete list of answers will, however
the responses may be less complete. Open-ended questions are often used
in the exploratory phase to improve understanding of a concept and what
18
language participants use to express it. The disadvantages of open-ended
questions are that they require qualitative methods to code and analyse the
responses which is time consuming and can be subjective (Hulley et al.,
2007). Close-ended questions are far more common, are quicker for the
participants to answer and easier to analyse. The disadvantage of close-
ended questions is that they are not exhaustive, one solution is to include an
option such as other (please specify)(Hulley et al., 2007). A useful strategy
is to conduct a pilot study using open questions on a smaller but
representative sample. From these responses the close-ended questions can
be formulated (Machin et al., 2007).
3.5 Testing
If inventories are to be useful, they should also undergo many of the same
reliability and validity checks as other instruments before being implemented.
Figure 1 shows the framework for the development and testing of the PSI.
19

Figure 1 Framework for the development and testing of the PSI
LITERATURE REVIEW
HEALTH
PROFESSIONAL
INTERVIEWS
FOCUS GROUPS
INTERVIEWS WITH
WOMEN
40- ITEM INVENTORY
FACE VALIDITY TEST RE-TEST
41 ITEM REFINED
INVENTORY
ACCEPTABILITY
TO MIDWIVES
USEFULNESS IN
PRACTICE
D
E
V
E
L
O
P
M
E
N
T

I
N
I
T
I
A
L

V
A
L
I
D
A
T
I
O
N

U
S
F
U
L
N
E
S
S

20
4 METHODS
4.1 Design
A mixed methods design was used. It involved inventory development and
testing using interviews, survey and focus group methods. Mixed methods
research is a research design that focuses on collecting, analysing and
mixing, both quantitative and qualitative data in a single study. Its central
premise is that the use of quantitative and qualitative approaches in
combination provides a better understanding of research problems than
either approach alone (Creswell & Plano Clark, 2007).
4.2 Aims
The aim of the project was to develop and validate a Pregnancy Symptoms
Inventory for use by pregnant women and healthcare professionals HCPs
providing their care.
4.3 Participants and setting
The study was conducted at the Royal Brisbane and Womens Hospital
(RBWH) Maternity Outpatients department, which cares for approximately
5000 pregnant women per year. Participants were medical and midwifery
staff who assisted in the development of the inventory and pregnant women
who were involved in its refinement and testing.
4.4 Procedure
The study was conducted in several phases; these will be described
individually.
21
4.4.1 Phase 1 (Expert consultation)
A group of health professionals working in the RBWH Maternity Outpatients
were interviewed and asked to name all the commonly occurring symptoms
of pregnancy that have been reported to them by the patients they had seen
over the years. The experts consisted of one obstetrician gynaecologist, one
obstetric physician and three experienced midwives. The interviews were
conducted in a semi structured format where the researcher was able to ask
for clarification if the expert described a symptom not encountered before.
The symptoms described by each person were kept in a log; to be reviewed
and categorized after all the experts had been interviewed. A list of
symptoms was then generated.
4.4.2 Phase 2 (Focus groups)
Pregnant women who were able to provide written informed consent and who
had booked in to the Maternity Outpatients department for their obstetric care
were included. Those with major medical problems eg diabetes, renal
impairment, severe psychiatric disturbances, substance abuse, mental
incapacity were excluded. Eligible women were sent a letter and invited to
participate in a focus group where their pregnancy symptoms would be
discussed (see Appendix 3). Focus groups were organised to coincide with
busy clinic days and women of the same trimester were invited to attend a
focus group prior to their routine clinic visit. It was hoped that by combining
the two in one trip to the hospital we would get a better attendance. This type
of recruitment is called opportunistic or convenience sampling. That is, the
researcher used opportunities when she was available, to ask people to
22
participate in the study who she thought may be able to provide useful
information (Holloway & Wheeler, 2002).
The groups were attended by women only (no male partners) to allow for free
discussion of symptoms experienced, as some symptoms were of a sensitive
nature. Whilst it was a preference that toddlers not attend, as we were
recording the focus groups and background noise makes it difficult to hear
the taped conversation, it was impossible to turn away women who arrived
with children as there was no one else to care for them. It in some ways
made the group feel like a mothers group having a chat about common or
unique experiences that the women had had during their pregnancy.
Refreshments were offered to create an informal feeling for the focus groups.
A second person was present to help with recording, note taking and
distracting children.
Focus groups consisted of three groups of 5-6 pregnant participants who had
provided written informed consent (Group 1 first trimester up to 12 weeks
gestation; Group 2 second trimester 12 to 28 weeks gestation Group 3 third
trimester 28 to 40 weeks gestation). The goal of the focus group was stated
at the beginning of each session with an explanation that it was the
individuals experience of pregnancy and any associated symptoms in which
we were interested. Equal participation by each woman was encouraged by
the researcher asking anyone who had not had a chance to speak if they had
different experiences.
A number of times the women needed to be led back to the purpose of the
focus group as they would stray off the subject or a particular participant
would take over. Questions were open-ended to encourage discussion
23
amongst the group. The women were asked about symptoms they had
experienced during their pregnancy and, if required, the researcher sought
further clarification or asked for an example to be given. The conversation
was audio taped and transcribed verbatim for analysis. The womens
terminology formed a basis for the wording of the items to ensure symptoms
were clearly understood.
4.4.3 Reconciliation of Data
All of the common symptoms from the literature review were identified by the
experts and by the women in the focus groups. Only one additional item vivid
dreams was proposed by the women. Therefore using a mixed methods
approach and combining data from each of these sources provides strong
validity for the content of the inventory.
4.4.4 Phase 3 (Development and testing)
Responses from interviews with professionals and focus groups interviews
were combined to develop the Pregnancy Symptoms Inventory. Items were
categorized by body part or system using terminology which is understood by
lay people eg gastrointestinal, aches and pains, sleep etc. See Table 2.
The reliability, validity and usefulness of the inventory were tested in a
number of ways.
4.4.4.1 Face Validity
Face validity investigates whether an instrument is calculating the
appropriate construct and whether the items within an instrument measure
the variables in a specific content area (Dempsey & Dempsey, 1992).
Initially, the entire inventory was reviewed by experts to test the face validity.
24
Two groups of 5-9 midwives were asked to comment and give feedback on
the symptoms listed, language used and the positioning of symptoms on the
inventory. All responses from the midwives were noted so that adjustments
could be made to better clarify the inventory.
It was designed to be easily read and understood and was limited to one 2-
sided page so as not to be onerous to fill out. The format allowed for
pregnant women to add additional symptoms and the midwives to add
comments and record their actions on the second page.
The Inventory was then piloted on a group of ten pregnant women to test
readability and comprehension. A number of changes were made to the
language used to describe the symptoms as it was obvious that certain
symptoms were not understood (for example Chloasma became Brownish
marks on face). Despite being asked to just circle terms not understood a
number of the women chose to fill in the questionnaire as well. In addition
two women were not Caucasian and had English as a second language, this
may have contributed to some difficulty with understanding the language.
However it is common to have a multiracial group in MOPD and therefore
useful to test the language used in the PSI on a heterozygous group of
women. See Table 1.
25
Table 1 Comprehension and readability of inventory (n=10)
Gestation Race Terms not understood Filled in
questionnaire
1 20 weeks Caucasian Chloasma N
2 28.5 weeks Caucasian Vaginal Varicose Vein Y
3 35 weeks Caucasian Vaginal Varicose Vein only
symptom not marked
Y
4 28 weeks Caucasian Vaginal Varicose Vein N
5 30 weeks Caucasian Vaginal Varicose Vein N
6 20 weeks Caucasian Y
7 30 weeks Indian Palpitations
Chloasma
partial
8 19 weeks Caucasian N
9 27 weeks Macedonian Vaginal Varicose Vein
Palpitations
Chloasma
N
10 26 weeks Caucasian N

4.4.4.2 Test re-test
The Inventory was completed by 20 women twice, 2-3 days apart to assess
for test-re-test reliability. This time frame was chosen as pregnancy
symptoms can change within a matter of days and the participants were
being asked to recall symptoms over the previous month. This was achieved
by asking the women who were at a routine antenatal visit to consent to fill in
the initial questionnaire. A second self administered questionnaire, which
was coded so that it could be compared to the inventory completed in clinic,
was given to the woman. She was asked to complete it again two to three
days later and send back in a pre-paid self addressed envelope. A second
group of 20 women was sent the questionnaire to complete at home a couple
of days before a planned visit. They were asked to bring the completed
inventory to their visit. They were then asked to repeat the inventory again as
they waited for their planned visit.
26
This was done to overcome a potential bias that suggests that answers may
vary, depending on the environment in which the survey is administered
(Mokkink et al., 2010).
4.4.4.3 Midwives perception of the usefulness of the inventory
Midwives working in the Maternity Outpatients department were educated
about the use of the Pregnancy Symptoms Inventory at their routine lunch
meetings at which 5 to 8 midwives attended. This was repeated several times
to maximize the number of midwives who were aware of the Pregnancy
Symptoms Inventory. The researcher also approached midwives on a one-
on-one basis as 3 midwives had not been present at the in-service sessions.
The one-on-one approach allowed the midwife to ask questions freely and
helped build up a rapport between the researcher and the midwives. The
midwives were informed that each woman arriving for a follow up visit would
be asked to fill in the PSI and asked to hand it to the midwife seeing them
that day. The midwives were then asked to peruse the PSI to see if any
issues had been flagged by the woman as occurring often or affecting them a
lot. This then allowed the midwife to discuss any problems and refer if
necessary to other HCPs. If the woman was to be referred to a HCP the
midwife was asked to record this on the PSI. The Maternity Outpatient
midwives were asked to use the inventory for a one month period and asked
to place the inventories they had been handed in a collection box at the
midwives counter. After the one month trial had ended the midwives were
asked to rate usefulness of the inventory (which was anonymous) on a10cm
visual analogue scale by placing a vertical line through the horizontal line
indicating how useful they found it to be. At one end it said Not useful at all
27
the other said Very useful. As well as rating the usefulness quantitatively,
midwives were also asked if using the instrument had prompted them to take
any action or if a referral had been organised. They were also asked to
comment on any other aspect of the inventory using an open-ended format.
See Appendix 4.
4.4.4.4 Practical use (Administration of the Inventory)
For this part of the testing phase, women attending the maternity outpatient
clinic were asked to think about symptoms that had occurred in the previous
month and rate them on a 4-point Likert scale according to the frequency of
symptoms never, rarely, sometimes, often. A 3-point Likert scale
following this question then asked them to rate how the symptom affected
their activities of daily living as not limited at all, limited a little or limited a
lot. See Appendix 5. The number of categories used in a rating scale has
been subject to debate. While the original Likert scale used 5 categories,
others have argued that more or less may be used, depending on the degree
of accuracy required or what the scales are going to be used for. These are
generally known as Likert-type scales. The choice of 4-item and 3-item
scales used in this study was based on these criteria (Kline, 2005). The
women were also asked to fill in their height, weight and number of weeks
pregnant at the top of the inventory. The inventory was distributed when
women first presented at the clinic. As there is usually a 10-15 minute wait
between arrival at the clinic and the actual midwife visit, they were asked to
complete the inventory, which took 5-7 minutes. This then enabled the
midwife to quickly peruse the inventory and see if there were any areas of
major concern to the woman. The midwife was able to discuss concerns and
28
make a comment in the Midwife action, Referral (please specify) or
comment sections as to what actions, if any, she had taken.
Initially administrative staff were asked to hand the inventory to women as
they arrived, so that the inventory could be filled in while they waited to see
the midwife. It was noted in the first week of the trial not all patients realised it
was to be given to their midwife and nine were handed back to the desk.
Subsequently, administrative staff were educated on the importance of the
inventory being handed to the midwives and this dramatically improved the
number of inventories that were placed in the midwives collection box.
4.5 Ethical Considerations
Approval was granted by the Royal Brisbane and Womens Hospital Ethics
committee and the Queensland University of Technology. The approval
letter is dated 30
th
Nov 2006 and was assigned the study number 2006/125
(Appendix 6). The Patient Information and Consent Form and patient
invitation letters were approved at that time (Appendix 7). In addition, medical
and nursing directors of Maternal and Newborn Services were approached
for their approval to conduct the study in their departments; the Nurse Unit
Manager also gave her support for the project.
Patients were approached on a individual basis by the researcher and asked
if they would be happy to participate in either a focus group, readability
testing or the test re-test reliability testing. A different group of women were
approached once the pregnancy symptom inventory was ready to be tested
in Maternity Outpatients, these were women booked in to midwife run clinics
for their antenatal care. They were advised that their confidentiality would be
29
maintained, that they were free to withdraw at any time and and that they
would not be reimbursed for their participation. They were given a Patient
Information and Consent Form outlining the study and asked to sign in the
investigators presence . This Information contained a statement on how to
contact the Ethics secretary if they wished to speak to someone outside of
the study. All data was stored in compliance with the Ethical standards
required by these Ethics committees.
Specifically, the patient information sheet outlined the following: title and
reason for the research; details of the researcher and supervisor; aim and
purpose of the study; types and methods of data collection; their ability to
withdraw at any time and that their data would be treated in a confidential
manner. They were also provided with contact numbers for answers to any
questions. The patient consent form followed the ethical standards and was
signed prior to interviewing, focus groups and surveying. Participants were
asked if they had read the information sheet and if they had any questions.
They were advised that they could withdraw at any time without ramifications
to their treatment and that study results may be published but in a de-
identified form (Appendix 7). The ethics committee approved the project
which outlined in detail how healthcare professionals (HCPs) working at the
RBWH MOPD would be asked for their opinion and involvement in this study
and did not require separate consent from midwives working in MOPD.
30
5 ANALYSIS
Due to the use of mixed methods in this study, strategies used for data
analysis are reported by phase. All quantitative data was analysed using the
statistical package SPSS version 16.
5.1 Development of inventory:
5.1.1 Phase 1: Expert consultation
Responses from doctors and midwives were collated and a list of symptoms
developed.
5.1.2 Phase 2: Focus groups
Conversations from the focus groups were tape recorded and transcribed.
These were carefully read to detect reference to any symptoms or problems.
When no new symptoms were being identified from discussions with the
women, a list was compiled and the symptoms classified; according to
system headings (for example gastrointestinal; skin/ hair). The additional
signs and symptoms identified through the focus group sessions were added
to the Inventory of initial items generated from the expert interviews. This
preliminary inventory was then shown to the midwives for their comment and
feedback.
5.1.3 Phase 3: Validating and testing the Inventory
5.1.3.1 Face validity
Comments from midwives and women about the wording and structure of the
inventory were analysed by scrutinising written comments.
31
5.1.3.2 Test re-test
Test re-test reliability for both the frequency and severity of each sign and
symptom were assessed using the Pearson's 'r' statistic. Correlation values
range from 0 to 1;values of 0.7 and over are considered to indicate
substantial agreement and values of 0.5 to 0.7 are considered to indicate
moderate agreement (Schene et al., 2000). Success of the different order of
administering the test re-test was evaluated by the proportion of complete
pairs of responses completed. Only those who returned both completed tests
were able to be evaluated.
5.1.3.3 Usefulness of the inventory
Because midwives responses to usefulness of the inventory on the 10cm
visual analogue scale were not normally distributed results were analysed
using the median and range. The VAS is converted to a score by measuring
the point at which the midwife put a vertical line through the 10cm horizontal
line and measured with a ruler in centimetres. Comments on the usefulness
of the inventory were reported verbatim. Referrals to other HCPs were
analysed using frequency distributions. See Table 3.
5.1.3.4 Practical use
Frequencies were determined by the number of those women experiencing a
particular symptom in the previous month. Demographic data and incidence
and severity of each of the symptoms were calculated using means with their
standard deviations (SD) for all continuous data (eg age, gestation). The
relationship between the frequency and severity of each condition on the
womans activities of daily living was assessed by the number of referrals
ordered or offered. When analysing this data frequencies were calculated on
32
completed answers only, missing responses were not used in this
calculation.
33
6 RESULTS
6.1 Phase 1 (Expert healthcare professionals consultation)
During this phase 40 items were produced. The items mentioned most
frequently were nausea, tiredness and sore breasts. Items generated by
experts are prefixed by the letter e in Table 2 and have been categorized by
body part or systems as follows. Healthcare professionals (HCPs) identified
twice as many signs and symptoms as did women in focus groups (40 verus
20). They also nominated all of the symptoms mentioned by the women,
except vivid dreams.
Table 2 Symptoms identified by healthcare professionals (e) and women (f)
Skin/Hair GI Mind Changes
Greasy skin-acne e f Nausea e f Short term
memory
e f
Varicose Veins e Reflux e f Depression e
Pigmentation-
chloasma
e f Constipation e Emotional Highs e f
Itch e Haemorrhoids e Vivid Dreams f
Change in nipples e Vomiting e f Altered body image e
Stretch Marks

e Dry Mouth e
Aches and Pains Genitourinary Sleep
Carpel Tunnel
(numb hands)
e Urinary frequency e f Restless Legs e
Aches e Vaginal Discharge e f Poor Sleep e f
Back pain e f Incontinence e f Snoring e
Sciatica e f Thrush e
Breast pain
(mastalgia)
e f Libido e f
Supra Pubic
Ligament Pain
e CVS General
Sacro Iliac Joint
Pain
e Dizziness e f Tiredness e f
Headache e f Palpitations e
Leg Cramps e Dyspnoea e
Sore Nipples e Taste/Smell
changes
e f
34

6.2 Phase 2 (Focus Groups)
There were twenty symptoms mentioned in the focus groups, nineteen of
which had also been mentioned by the experts; these are prefixed with both
e and f in Table 2.The additional item identified in the focus group sessions
was vivid dreams and is prefixed by the letter f in Table 2.
6.3 Phase 3 Validating and testing the inventory
6.3.1 Face validity (midwives)
Originally these symptoms were categorized by body part or system. Some
re-aligning of the position of some symptoms was suggested by the
midwives. Other valuable feedback was provided such as grouping restless
legs and leg cramps close to each other so that the women understood
these to be different symptoms. A number of symptoms were refined after
discussion with midwives eg supra pubic ligament pain and sacroiliac joint
pain became Hip or Pelvic pain. It was suggested Depression and Anxiety
should be listed separately. Fainting was added under dizziness. Food
cravings were added to the list as a separate item to taste/smell changes.
These changes were shown to the midwives who agreed on the face validity
of the new document.
One other useful comment was to highlight Please turn over in bold on the
bottom of the first page so that women did not forget to answer the second
page.
35
6.3.2 Face validity (Comprehension and readability of the
inventory by pregnant women)
The inventory was tested for comprehension and readability by a
convenience sample of 10 women attending their routine clinic visit. The
women were from mixed ethnicity and backgrounds. They were asked to
read the inventory and circle any word they did not understand. Three terms
were not understood eg Chloasma, Palpitations and Vaginal Varicose Vein.
These words were changed to Brownish marks on face, Heart Palpitations
and Painful Veins in Vagina.
Contrary to instructions, a number of the women filled in the inventory despite
being told to just circle the words they did not understand. A number of other
symptoms and comments were also added. Two women did not have English
as their first language however this does reflect the population seen in our
Maternity Outpatients. Details of responses are shown in Table 2.
6.3.3 Test re-test
Individual item test-re-test reliability was between 0.51-1 with the majority (34
items) scoring 0.70 indicating substantial agreement. See Table 3.
More women in the group who were sent the inventory at home first and then
asked to fill it in again in Maternity Outpatients completed both inventories.
Of the 20 women (gestation range 19 to 39.5 weeks), who were given their
first inventory in the clinic, only nine (45%) returned the second inventory in a
complete enough fashion to be used. By contrast, 14 (70%) of the 20 women
(gestation range 16.5 to 37 weeks), who had a clinic visit booked and who
were contacted by phone and asked if they would be happy to fill in the
36
inventory, remembered to bring in their inventory back and completed the
second inventory in clinic.
Two items did not have sufficient responses to calculate the correlations
(fainting and painful veins in the vagina). However, 23 of the remaining 39
items scored .80. Items such as nausea, reflux, constipation, dry mouth,
restless legs, thrush, carpel tunnel, shortness of breath, anxiety, vivid
dreams, varicose veins and change in nipples scored .090. Details of all
responses are shown in Table 3.

Table 3 Test re-test results for 23 women in Maternity Outpatients
Symptom R Symptom R
Nausea 1.0 Haemorrhoids .80
Constipation 1.0 Altered Body Image .80
Thrush .98 Breast Pain .79
Restless Legs .97 Dizziness .78
Dry Mouth .96 Heart Palpitations .77
Carpel Tunnel .94 Chloasma .77
Reflux .92 Itch .77
Anxiety .92 Forgetfulness .76
Change in Nipples .92 Poor Sleep .75
Vivid Dreams .91 Back Pain .71
SOB .90 Sciatica .70
Varicose Veins .90 Hip Pelvic Pain .70
Leg Cramps .89 Sore Nipples .70
Headache .88 Urinary Frequency .67
Food Cravings .87 Greasy skin .61
Vomiting .84 Stretch Marks .56
Snoring .84 Taste smell changes .55
Incontinence .84 Tiredness .51
Increased Vaginal
Discharge
.84 Painful veins in Vagina *
Change in Libido .84 Fainting *
Feeling Depressed .83
* Response not received
37
6.3.4 Usefulness of the inventory
Ten midwives of thirteen who were rostered to work in MOPD were surveyed
on the usefulness of the Pregnancy Symptoms Inventory after they used it for
one month in MOPD in March 2008 using a visual analogue scale (a 10cm
line). Of the three who did not complete the survey two were midwives filling
in from birth suite and felt they had not used the inventory for long enough to
comment and one midwife no longer worked for the hospital. The majority of
midwives (7 out of 10) rated the usefulness at >7 and 4 of these midwives
rated it 10 out of 10. The median VAS score was 8.4 (range .9 to 10). Nine
out of ten also said the pregnancy symptom inventory had prompted a
referral for a specific need. Comments indicated that the tool was generally
well accepted and that it had the potential for improving practice. For
example, one respondent said: Since the survey I have changed the way in
which I conduct a first booking in, to be more mindful of the symptoms of
pregnancy (especially incontinence). Good thing to always update. Another
said: This inventory was great at identifying pregnancy related issues that
are in need of referral. When educating midwives in MOPD on the use of the
PSI it was noted that the more experienced midwives appeared to embrace
the use of the PSI more willingly than the less experienced midwives. Full
details of scores and comments are shown in Table 4.

38
Table 4 Visual Analogue Scale and if PSI prompted referral and
associated comments (Midwife Survey)
Midwife VAS Referral Comment
1 10.0 Yes
2 .9 Yes Physio
3 10.0 Yes Very useful. Referrals made or identified by doing
this survey
4 10.0 Yes Keep doing it would love to have it continue
5 2.6 No
6 7.1 Yes
7 8.2 Yes While I found it helpful many midwives seemed to not
fully understand how it worked - so needed a easier
training explanation
8 8.6 Yes Since the survey I have changed the way in which I
conduct a first booking into be more mindful of the
symptoms of pregnancy (especially incontinence).
Good thing to always update.
9 6.8 Yes Possible opportunity for women to prioritise their
concerns. Otherwise very effective tool for
identification of symptoms although quite timely.
10 10.0 Yes This survey was great at identifying pregnancy
related issues that are in need of referral however
more time should be allowed at booking in visit to
complete as they are time consuming when you only
have an hour to complete the booking in visit

6.3.5 Practical use
6.3.5.1 Characteristics of Respondents
The inventory was given to 211 women attending a routine midwifery
appointment at the MOPD for routine antenatal care between 3
rd
March 2008
and 7
th
April 2008. Responses were received for all 211 women only a couple
of women approached did not want to fill in the inventory. Of the 159 women
who gave their age, the mean was 28.9 years (SD 6.16; range 15 44
years). The mean gestation was 23.06 weeks (SD 7.46; range 12-42 weeks).
None of the women surveyed were in the first trimester of their pregnancy.
The majority (153) were in their middle trimester (12-28 weeks) and 52 were
39
in their third trimester (28-42 weeks). The reason that there were no women
in their first trimester was because women do not present to Maternity
Outpatients for their first visit until 18 to 20 weeks unless they have a specific
medical need and are then seen by specialist doctors not midwives for these
visits. The mean Body Mass Index (BMI) for respondents was 26.8 (SD
5.89). This was based on the 174 (82.5%) women who nominated their
height and weight; the remaining 37 (17.5%) women did not know or wish to
disclose either their height or their weight as these questions were left blank.
See Table 5.
Table 5 Demographics of surveyed women (n=211 unless otherwise
stated)
Characteristic Range N (%) or Mean [SD]
Mean Age in Years 15-44 years 28.9 [6.157]
Mean Gestation in weeks 12-42 weeks 23.1 [7.5]
No. of Women < 12 weeks 0
No. of Women 12-28
weeks
153/205 (74.6%)
No. of Women 28-42
weeks
52/205 (25.4%)
BMI 15.8-50.7 26.76 [5.9]

6.3.5.2 Frequency of symptoms
The frequency of symptoms is shown in descending order in Table 6. The top
four often reported symptoms were urinary frequency 109 (52.2%),
tiredness 94 (45.5%), poor sleep 58 (27.5%) and back pain 41 (19.5%).
These were similar to the top four symptoms that women described as Limit
a Lot their daily activities (ADLs); these were back pain 19 (11%), tiredness
16 (9.2%), poor sleep 15 (8.5%) and nausea 13 (7%). The total number
responding to questions on Limit is less as only those who had experienced
40
that symptom were required to give an answer. Table 7 contains full details.
Whilst some of the symptoms had occurred often a number of symptoms
reported less frequently had the potential to adversely affect the womens
activities of daily living (ADLs). For example, incontinence was reported to
occur often by only eight (3.8%) women, however, 34 (16.2%) reported it
occurred sometimes or often and 16 (8.2%) said that this affected their ADLs.
Feeling depressed often was only reported to occur in 3 (1.5%) of our
sample however 28 (16%) women said it affected their ADLs. Poor sleep was
reported by 58 (27.5%) women as occurring often however 96 (54.5%)
women said that poor sleep affected their ADLs.
There were eleven other symptoms listed on the survey these were swelling
feet and hands (3),hair falling out (2), cramps (2), sore heels(1), body
stiffness (1), heavy stomach (1), sweating (1), pain under ribs (1), watery
eyes (1), cough (1), stuffy nose (1).The symptom which was least described
was fainting with only 2.5% of those who answered the question saying they
had experienced fainting sometimes. No one complained of fainting often.
41
Table 6 Prevalence of self reported often or sometimes experienced
pregnancy symptoms as a proportion of valid responses.
Frequency N= Valid
Responses
Often Sometimes Total
Prevalence
Urinary Frequency 209 52.2% 33% 85.2%
Tiredness 209 45.5% 41.5% 87%
Poor Sleep 211 27.5% 35.05% 62.55%
Back Pain 210 19.5% 40.5% 60.0%
Vaginal Discharge 205 17.6% 32.2% 49.8%
Forgetfulness 198 15.7% 39.9% 55.6%
Headache 200 14.5% 36% 50.5%
Vivid Dreams 201 13.9% 27.4% 41.3%
Taste Smell Changes 197 13.7% 20.3% 34.0%
Change in Nipples 196 13.3% 25% 38.8%
Nausea 207 12.6% 21.7% 34.3%
Change in Libido 197 11.2% 32% 43.2%
Hip Pelvic Pain 199 10.6% 23.1% 33.7%
Constipation 207 10.1% 23.1% 33.2%
Food Cravings 208 9.1% 28.4% 37.5%
Reflux 203 8.9% 20.7% 29.6%
Leg Cramps 210 8.6% 22.9% 31.5%
Dizziness 200 8.5% 19% 27.5%
Stretch Marks 193 7.8% 10.9% 18.7%
Greasy Skin Acne 199 7.5% 18.6% 26.1%
Restless Legs 208 7.2% 23.1% 30.3%
Dry Mouth 210 7.1% 25.7% 32.8%
Breast Pain 173 6.5% 25.5% 32.0%
Altered Body Image 190 6.3% 19.5% 25.8%
Vomiting 210 6.2% 11.4% 17.6%
Sore Nipples 199 6.0% 23.6% 29.6%
Shortness of Breath 201 5.0% 25.9% 30.9%
Itch 198 4.5% 17.7% 22.2%
Snoring 207 4.3% 10.6% 14.9%
Varicose Veins 194 4.1% 12.9% 17.0%
Incontinence 209 3.8% 12.4% 16.2%
Carpel Tunnel 208 3.4% 7.7% 11.1%
Sciatica 209 3.3% 14.4% 17.7%
Anxiety 200 3.0% 16.5% 19.5%
Chloasma 201 3.0% 3.0% 6.0%
Thrush 203 2.5% 6.4% 8.9%
Painful Vein in Vagina 204 2.5% 2.9% 5.4%
Haemorrhoids 203 1.5% 4.4% 5.9%
Feeling Depressed 201 1.5% 20.4% 21.9%
Heart Palpitations 197 1.0% 9.1% 10.1%
Fainting 198 0.0% 2.5% 2.5%
As the number of women responding to questions varied, the denominator is displayed for
each symptom (N)
42
Table 7 Prevalence of self-reported limitation as a proportion of those
women who reported experiencing the symptom.
Frequency N Limit a lot Limit a
little
Total Prevalence
Back pain 173 11.0% 41% 52.0%
Tiredness 173 9.2% 67.3% 76.3%
Poor Sleep 176 8.5% 46% 54.5%
Nausea 186 7% 23.1% 30.1%
Headache 167 6.6% 44.3% 50.9%
Hip Pelvic Pain 199 6.3% 22.2% 28.5%
Vomiting 194 5.2% 13.9% 19.1%
Forgetfulness 168 4.8% 29.8% 34.6%
Sciatica 195 4.1% 9.3% 13.4%
Urinary Frequency 173 2.9% 36.4% 39.3%
Change in Libido 175 2.9% 14.9% 17.8%
Altered body image 172 2.3% 8.1% 10.4%
SOB 177 2.3% 23.2% 25.5%
Dizziness 177 1.7% 26.2% 28.3%
Stretch Marks 174 1.7% 2.3% 4.0%
Food Cravings 183 1.6% 3.3% 4.9%
Leg Cramps 183 1.6% 15.3% 16.9%
Restless Legs 184 1.6% 12% 13.6%
Incontinence 194 1.5% 6.7% 8.2%
Change in Nipples 171 1.2% 4.7% 5.9%
Constipation 185 1.1% 10.3% 11.4%
Reflux 186 1.1% 14% 15.1%
Thrush 194 1.0% 3.1% 4.1%
Painful vein in Vag 200 1.0% 2.5% 3.5%
Vaginal Discharge 173 0.6% 6.9% 7.5%
Taste Smell changes 178 0.6% 15.2% 15.8%
Breast Pain 174 0.6% 8.0% 8.6%
Anxiety 200 0.6% 12.2% 12.8%
Feeling Depressed 175 0.6% 15.4% 16.0%
Greasy skin acne 182 0.5% 4.9% 5.4%
Dry Mouth 189 0.5% 2.6% 3.1%
Itch 183 0.5% 4.4% 4.9%
Snoring 188 0.5% 1.6% 2.1%
Varicose veins 183 0.5% 4.4% 4.9%
Carpel tunnel 204 0.5% 4.4% 4.9%
Vivid dreams 175 0.0% 4.6% 4.6%
Sore Nipples 174 0.0% 8.2% 8.2%
Chloasma 190 0.0% 0.5% 0.5%
Haemorrhoids 199 0.0% 1.0% 1.0%
Heart Palpitations 190 0.0% 6.3% 6.3%
Fainting 190 0.0% 2.1% 2.1%
As the number of women responding to questions varied, the denominator is displayed for
each symptom (N). Women who did not experience a symptom did not answer limit question.
43
6.3.5.3 Relationships between symptoms and referrals
Because a number of symptoms seemed to be linked a post-hoc analysis
was conducted. Statistically significant relationships can be seen in Table 8.
Poor sleep had a strong association with a number of symptoms including
back pain (0.001), restless legs (0.013), feeling depressed (0.002), anxiety
(0.043), tiredness (0.008) and urinary frequency (0.018). Tiredness and
Nausea were also related (0.028).
Table 8 Statistically significant relationships between symptoms and
referrals from the inventory (n=211)
Symptom P* N of valid cases
Tiredness and Nausea 0.028 206
Poor Sleep and Back pain 0.001 210
Poor Sleep and Restless Legs 0.013 208
Poor Sleep and Feeling Depressed 0.002 201
Poor Sleep and Anxiety 0.043 200
Poor Sleep and Tiredness 0.008 209
Poor Sleep and Urinary Frequency 0.018 209
Feeling Depressed and Mental Health Nurse 0.008 201
Anxiety and Mental Health Nurse 0.004 200
Back Pain and Physio Referral 0.002 210
Hip/ Pelvic Pain and Physio Referral 0.009 199
*Pearsons Chi-Square

Referrals
In the one month trial midwives made or suggested a number of referrals
[see Table 9]. Of the 211 inventories 25 (11.9%) women were referred to a
physiotherapist with an additional 10 (4.7%) declining the physiotherapy
referral; 11 (5.2%) women were referred to the continence nurse with an
additional two (1.0%) declining this referral; and five (2.4%) were referred to
the mental health nurse; six (2.8%) more women, who were assessed as
44
needing mental health support declined the referral. Relationships between
symptoms and referrals included: physiotherapy referral and back pain
(0.002); physiotherapy referral and hip/pelvic pain (0.009); mental health
nurse referral and feeling depressed (0.008) and mental health nurse referral
and anxiety (0.004).
Table 9 Proportion of referrals by midwives documented on
Pregnancy Symptom Inventory (n = 211)
Referrals N (%)
Physiotherapy Referrals 25 (11.8%)
Continence Nurse Referral 11 (5.2%)
Blood Tests 6 (2.8%)
Mental Health Nurse Referral 5 (2.3%)
Dietitian Referral 2 (0.9%)
Urine Tests 2 (0.9%)
Social work Referral 1 (0.4%)
General Practitioner Referral 1 (0.4%)

Declined Physiotherapy

10 (4.7%)
Declined Mental Health Nurse 6 (2.8%)
Declined Continence Nurse Referral 2 (0.9%)
Declined Social Work Referral 1 (0.4%)

Other referrals made by the midwives included referral for blood tests (ie
haemoglobin for women complaining of tiredness or shortness of breath) and
midstream urine tests ordered for women with frequency of urine.
The continence nurse keeps accurate records of all referrals she receives
from the MOPD. Consequently, she was able to provide a snap shot of
referrals made during the 12-month period in which the trial was conducted.
The trial of the inventory ran from March 3
rd
2008 to 9
th
April 2008 in the
MOPD. As can be seen in Figure 2, there was a dramatic rise in the number
45
of referrals to the continence nurse in the month of March 2008 (from an
average of 1.8/month for the year up to 17 referrals in March) when the
pregnancy symptoms inventory was being trialled. This represents more than
an eight-fold increase in the number of referrals. The effect of the inventory
on referrals is further demonstrated by a return to normal referral patterns
once the trial finished. The discrepancy between the number of referrals (11)
made by midwives who used the inventory and the continence nurse (17)
could be that the midwife forgot to note their referral on the inventory or other
physician-based referrals were made to this service from MOPD.
Referrals to the physiotherapist and the mental health nurse can be seen in
Table 9. It was not possible to gain accurate referral numbers for the
previous 12 months from these departments.

Figure 2 Incontinence referrals from Maternity Outpatients

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46
7 DISCUSSION
7.1 Questionnaire Development
The development of the Pregnancy Symptoms Inventory followed a rigorous
multi- step approach involving a literature review, expert interviews, focus
groups, face validity testing, comprehension and readability assessment,
test-re-test analyses and content analysis to produce a multi-item scale
which was piloted by midwives who then assessed its usefulness on a Visual
Analogue Scale. The available literature on health scale development
supports the use of these methods when designing such a tool. (Bowling &
Ebrahim, 2005; Cheraghi et al., 2009; Hulley et al., 2007; Victorson et al.,
2008). This study focused on the development of a tool that
comprehensively assessed multiple symptom categories on a scale reflecting
important clinical criteria. It was designed to be on a 2-sided page so that it
could be easily read and understood and not too onerous to fill out. It also
allowed for pregnant women to add additional symptoms and the midwives to
add comments and record their actions on the second page. Keeping it to
one page would allow it to be added to the womens medical notes more
easily for future reference.
The aim of this study was to design and validate a Pregnancy Symptoms
Inventory. The extent to which this aim has been achieved will be discussed
using a framework of the specific research questions asked and the
hypotheses proposed. For convenience and because they are associated,
question one and question two will be combined.
47
Question 1: What pregnancy signs and symptoms are reported by
healthcare professionals? And
Question 2: What pregnancy signs and symptoms are reported by
patients?
The Pregnancy Symptoms Inventory (PSI) is a new, comprehensive
instrument for use in antenatal care. It was developed using semi structured
interviews with expert healthcare workers, working in an obstetric
environment and focus groups of pregnant women. Healthcare professionals
identified twice as many signs and symptoms as did women in focus groups
(40 verus 20). They also nominated all of the symptoms mentioned by the
women, except vivid dreams. This may be because HCPs see so many
women in their work life and are very familiar with problems reported to them.
Whereas the women in the focus groups had only their own experiences from
which to draw. Healthcare professionals (HCPs) were also more likely to
mention physical problems such as dyspnoea, sacro-iliac joint pain, nipple
changes, stretch marks and varicose veins than the women. However, this
may be an artefact of the numbers in the focus groups which totalled 5-6
women. These numbers may not have allowed for the full diversity of
symptoms experienced during pregnancy. Irrespective of this, it was
pleasing to see that healthcare professionals (HCPs) did nominate all of the
issues that were also a concern to women. However, it does not follow that
they necessarily enquire about these problems at an antenatal visit, so the
self-completed inventory should prove useful for women when engaging in
dialogue with their HCP. The dramatic increase in incontinence referrals for
48
the month the PSI was used certainly supports the notion that it helps to
engage women and their HCP in dialogue about issues which are troubling.
The most often reported symptoms in the inventory of 211 women were,
urinary frequency (52.2%) tiredness (45.5%) poor sleep (27.5%) and back
pain(19.5%) this is in agreement with the findings in Zib et als 1999 study
which stated all 4 of these symptoms in their top 5 most frequently reported
symptoms. Nausea was described by 34.3% of the surveyed women who
were in their 2
nd
or 3
rd
trimester and 30.1% said it had affected their daily
activities. As it is commonly expected that many women suffer nausea in
their first trimester and that many describe it as disappearing in their 2
nd

trimester this is a significant number of women who had nausea beyond the
first trimester. Lacasse et al 2009 described 40.1% of her 367 patients
suffered nausea and vomiting of pregnancy into their second trimester. Davis
2004 found in her evidence based review that only 50% of pregnant women
had relief by 14 weeks(Davis, 2004).
Tiredness or fatigue was reported in this study sometimes or often in 87%
of the women. This is almost identical to the study of 476 Scandinavian
women which showed that over 90% of their sample experienced fatigue
throughout their pregnancy (Rodriguez et al., 2001). This, almost universal
state, may be due to the physical affect of pregnancy per se or the heavy
workload demands on women in general, who are frequently in full-time
employment as well as managing households.
Back pain affected 60% of our sample, sometimes or often and this concurs
with a number of studies that report rates of between 55-75% (Kristiansson et
49
al., 1996; Mogren & Pohjanen, 2005; Orvieto et al, 1994; Pool-Goudzwaard,
2005). Although such a high proportion of women reported back pain, very
few are referred to a physiotherapist for management. For example, when we
reviewed referral patterns only 17% had been offered physiotherapy referral.
This highlights the need for greater attention to be paid to symptoms during
pregnancy. The Pregnancy Symptoms Inventory should prove useful in
alerting HCP to signs and symptoms they may otherwise be unaware. The
inventory when added to the patient record may also result in a reduction in
the frequency of repetitive questions about their symptoms.
In summary, seeking advice from experts and pregnant women gave a well
rounded picture of the many and varied symptoms experienced in pregnancy.
It was reassuring to have a large number of the symptoms reported from both
sources. Whilst this Pregnancy Symptoms Inventory is not exhaustive it is
detailed and allows for other symptoms to be listed by the woman giving her
an opportunity to bring up any other symptom that has been bothersome.
The generation of an inventory of symptoms known to occur in pregnancy
may help as many women do not associate a range of symptoms with being
pregnant and are unaware that pregnancy can cause or exacerbate
symptoms. Anecdotal evidence from pregnant women indicates that there is
a culture of putting up with discomforts which in some cases can be
alleviated by appropriate care and treatment for example tiredness and
shortness of breath can both be symptoms of a low haemoglobin and easily
treated with iron supplements. Frequency of urine can indicate a urinary tract
infection which are common in pregnancy and easily identified if a microurine
sample is taken and sent to pathology. Back pain can benefit from
50
physiotherapy for strengthening exercises and incontinence problems
alleviated by referral to the incontinence nurse or physiotherapist for pelvic
floor exercises.
Question 3: Can these signs and symptoms be combined in a
pregnancy symptoms inventory that would be useful to health workers
who provide care to pregnant women?
Initial testing of the PSI in the current study is encouraging. Some questions
had a lower response rate and it may be useful to investigate reasons for
this. However, the lowest response rate was 82%, which remains acceptable.
Face validity testing produced some changes that were easily incorporated
after being reviewed by a random group of pregnant women from different
ethnic backgrounds and experienced midwives. Dempsey and Dempsey
(1992) stated that face validity investigates whether an instrument is
calculating the appropriate construct and whether the items within an
instrument measure the variables in a specific content area. The test re-test
results showed the majority of symptoms 87% scored .70 and 59% scored
.80%. It was also well accepted by staff and patients with many positive
comments made by experienced midwives. Forty percent of the midwives
surveyed scored the inventory at the highest possible score 10 out of 10.
Seventy percent of the midwives scored the usefulness at 7 out of 10 or
higher. Of the three midwives who scored the usefulness at less than seven
out of 10 one referred to a physiotherapist as a result of using the tool and
the other commented that it was a very effective tool for identification of
symptoms but made a comment on how long it took .
51
Question 4. Does the use of a pregnancy symptoms inventory result in
an increase in referrals to appropriate service providers?
The rate of referrals to our continence nurse, increased by over 8 fold the
month of the trial. This backs up Chiarellis 2004 claim that patients and
medical practitioners alike are reticent to discuss this somewhat
embarrassing subject (of incontinence.) This study lead to the MOPD adding
a question on continence to their clinic visits with midwives, as this issue had
clearly been under reported in the past by patients.
During the study period referrals to other healthcare professionals were
made and recorded on the PSI however it is unclear if the referrals were an
increase on usual practice as no baseline data for these referrals was
available. Women who described urinary symptoms were asked for a
microurine to rule out urinary tract infections as a cause. This is well within
the scope of practice for midwives. Other issues such as tiredness, fatigue
and shortness of breath were managed by ordering a full blood count to
check the womans haemoglobin levels which can often dip in pregnancy.
This is often treated with iron supplements.
Early detection and treatment of symptoms can often prevent a worsening of
the symptom which can lead to loss of work and quality of life. The American
College of Obstetricians and Gynaecologists 2004 guidelines on nausea and
vomiting of pregnancy state failure to treat early manifestations of nausea
and vomiting of pregnancy increases the likelihood of hospital admissions for
hyperemesis gravidarum. It has also been stated that cultural beliefs and
taboos, lack of knowledge and information, and lack of healthcare providers
52
knowledge regarding incontinence all contribute to a lack of treatment
seeking (Bush et al., 2001).
7.2 Hypotheses
The study proposed two hypotheses:
1) That a pregnancy symptoms inventory, when used as part of a
standard prenatal visit, will be useful to healthcare professionals; and
2) That a pregnancy symptoms inventory will identify, and be able to
discriminate between mild conditions and those requiring intervention.
The first hypothesis is supported. It has been clearly shown that the midwives
in the Maternity Outpatients found it to be a useful tool with comments such
as Referrals made or identified by doing this inventory and very effective
tool for identification of symptoms being made. Other comments which
indicate that the PSI has the ability to implement practice change include
Since the survey I have changed the way in which I conduct a first
booking in to be more mindful of the symptoms of pregnancy
(especially incontinence). Good thing to always update.
The second hypothesis was supported to some extent. There was certainly
some evidence that women who reported symptoms, often, were referred to
a healthcare professional. The aim of any new tool would be that referrals are
only made where necessary so as not to waste limited resources. To the
authors knowledge, this is the first time such a relationship has been shown
and provides further evidence for the usefulness of the Inventory in both
practice and in research settings.
53
7.3 Midwives Attitudes and Practice Change
One finding which was a surprise to the researcher was that the more
experienced midwives in clinic seemed to be more open and accepting of the
Pregnancy Symptom Inventory as a potentially useful risk assessment tool,
whilst the less experienced midwives were cautious of this new form. It is
often felt that older people are more resistant to change (McGregor & Gray,
2002) but conversely the more senior midwives experience may have lead
them to accept something they see as making their job easier.
One of the comments made was that the inventory was seen as more work
and that they would need more time to do a booking in visit if they were to
go through the inventory with each woman.
It would appear that other researchers (McKellar et al., 2009) discovered
that the negativity of the ward midwives regarding innovations implemented
in her study contrasted strikingly with the positive responses from both
parents and the action research midwives. She explained that two themes
emerged which may explain the response of the midwives to the actions;
firstly a lack of ownership of the actions and secondly, the problematic nature
of the current culture of the postnatal-care environment. Whilst this study
refers to the postnatal environment and the current study was done in the
antenatal setting of the busy Maternity Outpatient clinic, similar themes of
time pressure and midwives being rotated in from other areas to perform
tasks is common to both settings. In such busy situations, a researcher
asking for assistance to trial an inventory may appear onerous to some staff.
54
Implementing practice change is always difficult but it is often facilitated by
the presence and support of a clinical champion from the area, one who has
the respect of other staff. Other suggestions when implementing the PSI
would be to conduct inservice sessions outlining which patients to refer to
physiotherapy, the continence nurse, the mental health team or which blood
tests to order for certain symptoms. The impression from the current study
was that in general, staff were trying to do a good job in an often hectic
environment. One of the factors that contributed to the success of the project
was that the investigator had been exposed to the staff in the previous 12-
months whilst working on another project in the Maternity Outpatients clinic;
so was consequently well known and trusted.
7.4 Limitations
There were a number of qualitative aspects to the study, which are potentially
open to biases (Mays & Pope, 1996). Strategies to reduce the researchers
bias /own opinion included the use of a mixed method approach where
information underpinning the development of the inventory was sought from
two different groups (expert interviews and focus groups). Subsequently the
instrument was subjected to validation by experts and other pregnant
women. There were also inservice sessions with the midwives where they
were asked for comment and allowed to express their views regarding the
Pregnancy Symptoms Inventory. Despite the addition of the words please
turn over in bold on the bottom of the first page, a number of women still
only filled in one page of the inventory. This could have occurred due to lack
of time before being called into clinic visit or disinterest.
55
Another limitation was the lack of baseline data around referrals to other
health professionals, and blood and other test ordering patterns. The only
useable baseline data was from the Continence Nurse, so it was not possible
to determine the affect of the inventory on other areas. However, the
midwives did indicate on the PSI, that after reviewing responses they had
offered their patient a referral or ordered a test.
The Pregnancy Symptoms Inventory (PSI) provides information only on
women in their second and third trimesters as none of the 211 women
surveyed with the PSI were in their first trimester. This is because the
majority of women are not booked in to MOPD until 18 weeks unless they
have a medical condition or a previous pregnancy outcome which indicates
that they need early follow up. Before their first visit to our clinic, women see
their own general practitioner (GP) for pregnancy confirmation and early
pregnancy care. These GPs were too numerous to make it feasible to access
women in their first trimester.
However, focus groups did include women who were in their first trimester
and the discussions with this group predominantly discussed nausea,
vomiting and tiredness as a major concern early in their pregnancy.
Therefore the incidence of these symptoms may be higher if we had a more
representative group. The symptom swollen hands and feet, common in
pregnancy, were somehow not mentioned in discussions with experts and
focus groups. This problem was noted by a woman on the other symptoms
early in the survey of 211 but was not feasible to add as the inventory was
underway. There were eleven other symptoms listed on the survey these
were swelling feet and hands (3),hair falling out (2), cramps (2), sore
56
heels(1), body stiffness (1), heavy stomach (1), sweating (1), pain under ribs
(1),watery eyes (1), cough (1), stuffy nose (1).
7.5 Implications for Practice
The Pregnancy Symptoms Inventory may be a useful tool for pregnancy care
providers when used to detect and treat symptoms and could become part of
routine care. The effectiveness of the instrument may be enhanced if the
midwife addressed any unanswered items, as they may not have been
understood. One current outcome of this study has been that the MOPD at
the Royal Brisbane and Womens Hospital has introduced a pathway for
asking questions on continence based on the huge increase in referrals to
the Continence nurse during the study and this is now a routine part of the
antenatal visit.
Introduction of the Pregnancy Symptom Inventory by a clinical champion
from the clinic in which it is to be used, would aid acceptance of the tool. It
could be accompanied by a clinical pathway or decision tool to provide
guidance about 1) when to refer and to whom; 2) appropriate test to order
and; 3) appropriate advice to provide. In terms of the instrument itself,
swollen hands and feet should be added to the inventory; it is a very common
symptom and, in certain patients an indicator that they could be developing
preeclampsia.
7.6 Implications for Pregnant Women
There are many old wives tales surrounding pregnancy, many learnt from
family and friends and not always evidence based which gives women a
distorted view of what is normal in pregnancy. Some symptoms such as
57
incontinence may be embarrassing for women to bring up with their midwife.
So the ability to tick a box on an inventory, which is reviewed by their
midwife, who can then take appropriate action referring them where
necessary, may benefit women. For example 13 women offered a continence
referral 11 women accepted the referral to seek help for their symptoms.
Pregnant women who were involved in the focus groups and those who
completed the inventory were more than happy to share their experiences. In
the focus groups, in particular, women who did not know each other found
the experience of being pregnant at the same time a bonding experience and
were very happy to discuss their individual experiences. They seemed happy
that someone was interested in how they were feeling.
7.7 Recommendations for Research
Further testing of the usefulness of the inventory in larger and other
populations is required. In any such research, baseline data around referral
patterns and the ordering of blood and other tests should be collected. This
would allow the effect of the Inventory on these indicators to be measured.
Any future research should include women in their first trimester. It could be
beneficial to record the parity as it would be interesting to see if this has any
effect on outcomes.
In addition, the PSI could be used as an outcome measure to assess the
impact of lifestyle interventions, in pregnancy, such as increased social
support or exercise programs. The Inventory would be useful in these
circumstances because social issues, support and access to health care are
58
frequently related to many of the symptoms described, such as depression,
nausea/vomiting and pain.
7.8 Conclusions
At this time no brief comprehensive assessment tool exists that examines
pregnancy related symptoms in their entirety. The results of the reliability and
validity of the tool are promising. The Pregnancy Symptoms Inventory was
generally well accepted by midwives and could be a useful tool for pregnancy
care providers, aiding clinicians in early detection and subsequent treatment
of symptoms.
59
Acknowledgements

I would like to thank the midwives and administrative staff in the Maternity
Outpatients at the Royal Brisbane and Womens Hospital for their help in
conducting this study in their department.
Also my supervisors Nuala Byrne and Joan Webster for their invaluable
advice and expertise.
I would not have been able to proceed with this research without the support
of Dr Charles Denaro and Dr Leonie Callaway.
60
Appendix 1 Prevention of Gestational Diabetes

Due to copyright restrictions, this article is
not available here. Please consult the
hardcopy thesis available from QUT Library
or view the published version online at:

http://dx.doi.org/10.2337/dc09-2336
64
Appendix 2 Exercise in obese pregnant women:
The role of social factors, lifestyle and pregnancy
symptoms
Exercise in obese pregnant women: The role of social
factors, lifestyle and pregnancy symptoms.

Katie F Foxcroft*
, Ingrid J Rowlands*
2
, Nuala M Byrne
3
, H David McIntyre
4
,

and
5
Leonie K Callaway
5
For the BAMBINO group

Department of Internal Medicine, Royal Brisbane and Womens Hospital, Brisbane,

Australia

Queensland Institute of Medical Research and School of Population Health,

University of Queensland, Brisbane, Australia.
3
School of Human Movement Studies and Institute of Health and Biomedical
Innovation, Queensland University of Technology, Brisbane, Australia
4
, Head of Mater Clinical School, School of Medicine, University of Queensland
5
, Royal Brisbane and Womens Hospital and School of Medicine, University of
Queensland, Brisbane, Australia

* These authors contributed equally to this work
Corresponding author
The complete BAMBINO Group: Leonie K.Callaway, Paul B.Colditz, Nuala
M.Byrne, Barbara E. Lingwood, Ingrid J. Rowlands, Ainsley Groves, Xanthe
Sansome, Briony R. OConnor, Susan Croaker, Katie Foxcroft, and H.David
McIntyre
Email addresses:
KFF: katie_foxcroft@health.qld.gov.au
IJR: Ingrid.Rowlands@qimr.edu.au
NMB: n.byrne@qut.edu.au
HDM: david.mcintyre@mater.org.au
LKC: l.callaway@uq.edu.au
-1-

Abstract
Background
Physical activity may reduce the risk of adverse maternal outcomes, yet there are very
few studies that have examined the correlates of exercise amongst obese women
during pregnancy. We examined which relevant sociodemographic, obstetric, and
health behaviour variables and pregnancy symptoms were associated with exercise in
a small sample of obese pregnant women.
Methods
This was a secondary analysis using data from an exercise intervention for the
prevention of gestational diabetes in obese pregnant women. Using the Pregnancy
Physical Activity Questionnaire (PPAQ), 50 obese pregnant women were classified as
Exercisers if they achieved 900 kcal/wk of exercise and Non-Exercisers if they
did not meet this criterion. Analyses examined which relevant variables were
associated with exercise status at 12, 20, 28 and 36 weeks gestation.
Results
Obese pregnant women with a history of miscarriage; who had children living at
home; who had a lower pre-pregnancy weight; reported no nausea and vomiting; and
who had no lower back pain, were those women who were most likely to have
exercised in early pregnancy. Exercise in late pregnancy was most common among
tertiary educated women.
Conclusions
Offering greater support to women from disadvantaged backgrounds and closely
monitoring women who report persistent nausea and vomiting or lower back pain in
early pregnancy may be important. The findings may be particularly useful for other
interventions aimed at reducing or controlling weight gain in obese pregnant women.
-2-

Word count: 231
-3-
Background
Physical activity during pregnancy is important for womens general health and may
reduce the risk of adverse maternal, fetal and neonatal outcomes. Current
recommendations advise pregnant women without medical or obstetric complications
to aim for 30 minutes of physical activity on most days of the week [1]. Randomised
controlled trials have shown that the uptake of regular exercise among sedentary
pregnant women has significant benefits for women in pregnancy. Specifically,
women who participated in three hours of weekly vigorous exercise in pregnancy
reported greater satisfaction with their physical stamina, energy levels, appearance
and general health than sedentary pregnant women [2]. In another study of pregnant
women who were overweight, participation in three hours of aerobic exercise per
week was associated with higher fitness levels as demonstrated by increased oxygen
uptake, than overweight women who remained sedentary [3]. Exercise also appears to
have benefits for neonates, with the uptake of moderate-intensity exercise in
pregnancy being associated with normal fetal growth [4]. However, some women may
have difficulty meeting current recommendations, or participating in physical activity
altogether during pregnancy because of health and psychosocial factors.
The correlates of physical activity among women during pregnancy have been
examined in only a few studies. Sociodemographic variables such as education and
income [5-8] have been positively associated with physical activity in pregnancy
whereas a negative association has been found for age [7, 9]. Women who have
children at home and an unfavourable pregnancy history [9] are less likely to be
physically active during pregnancy. Although there is limited evidence, psychosocial
variables such as employment during pregnancy and lack of childcare [10] have also
been identified as correlates of physical activity in pregnancy [11]. However, overall
-4-
the evidence tends to be conflicting with several studies finding no relationship
between these variables and womens physical activity levels during pregnancy.
Womens physical health and health behaviours before and during pregnancy may be
important predictors of physical activity during pregnancy. Women who have a high
pre-pregnancy body mass index (BMI) [11] or who smoke [6, 7] are less likely to be
physically active in pregnancy. On the other hand, pre-pregnancy physical activity has
been associated with remaining physically active during pregnancy [10]. Remaining
active during pregnancy may be beneficial for womens well-being, with one study
showing that exercise during the first trimester of pregnancy was related to reduced
reporting of nausea and vomiting in the 2
nd
trimester of pregnancy[12].
Physical symptoms are common and normal in pregnancy, but they may deter or
prevent some women from exercising during pregnancy. For example, almost 80% of
pregnant women experience nausea and vomiting [12] in their first trimester.
Although this generally resolves by the 12th week of pregnancy, around 40% of
women report nausea and vomiting into their second trimester and some women are
affected for the entire pregnancy. Further, back pain during pregnancy affects
anywhere between 24 and 90% of women and may interfere with womens ability to
exercise [13, 14]. While pregnancy symptoms may have a large impact on womens
wellbeing, there is evidence to suggest that exercise may improve womens
symptoms[8].The correlates of exercise during pregnancy among women who are
obese have not been examined. Women who are obese are at the greatest risk for
pregnancy complications [15] and weight retention in the longer term [16], and thus it
seems important to examine whether there are factors that are common to obese
pregnant women who do exercise. This study examines the correlates of exercise in a
small sample of pregnant women who were identified as achieving, or not achieving
-5-
adequate exercise-specific energy expenditure requirements throughout their
pregnancy. We expected that the relevant sociodemographic, obstetric and health
behaviour variables, and pregnancy symptoms, would be associated with exercise
during pregnancy in this group of women. This information would be useful for
informing lifestyle interventions that aim to reduce or control weight gain among
obese pregnant women.
Methods
Participants
This is a secondary analysis of a study of 50 women who were recruited as part of a
randomised controlled trial (RCT) examining the feasibility of an individualised
exercise program for obese women during pregnancy. Full details of study design and
participant recruitment have been reported previously [17]. Women receiving
antenatal care and delivering at the Royal Brisbane and Womens Hospital (RBWH)
in Queensland, Australia, were recruited from the hospitals maternity outpatient
clinic between 12 and 14 weeks gestation. Ethics clearance was obtained for the study
from the Royal Brisbane and Womens Hospital (RBWH) Human Research Ethics
Committee. The RCT study is registered with the Australian Clinical Trials Registry
(ACTRN012606000271505). Women were included in the study if they were: aged
18-45; had a BMI of 30 kg.m
-2
or greater; were willing to participate in an exercise
program; and able to provide informed consent. Exclusion criteria included: non-
English speaking; contraindication or inability to exercise; medical or obstetric
contraindication to exercise including hemodynamically significant heart disease;
restrictive lung disease; incompetent cervix (cerclage); multiple gestation; severe
anemia; chronic bronchitis; type 1 diabetes; orthopaedic limitations; poorly controlled
seizure disorder; poorly controlled hyperthyroidism; heavy smoker.
-6-
Pre-intervention Stage.All eligible women were invited to attend a single early group
education session at around 12 weeks gestation. Women received written information
on exercise[1], nutrition [18] and weight gain during pregnancy[19]. The women were
subsequently invited to attend a face-to-face interview with a research midwife.
Interviews collected information on demographics and physical and mental health and
health behaviours.
Intervention
Women randomized to the intervention received a) an individualised exercise plan b)
regular exercise advice and c) paper-based diaries for self-monitoring. A face-to-face
interview at 12 weeks with a physiotherapist, who had expertise in pregnancy
management and exercise physiology, was conducted to develop womens
individualized exercise plans; to assess readiness for change, and encourage goal
setting. Women were reviewed every 4 weeks by physiotherapists, with phone calls
between visits to assess their adherence to the program. Women who were not
meeting exercise targets had additional face-to-face support, with identification of
barriers and modification of the exercise plan.
Both the intervention and control groups were followed up at 12, 20, 28 and 36 weeks
by a research midwife who recorded their weight, pregnancy symptoms and
administered the PPAQ.
Energy Expenditure
We examined the correlates of energy expenditure, which are expressed as
kilocalories per week (kcal) in this paper. Energy expenditure was derived from the
Pregnancy Physical Activity Questionnaire (PPAQ). Data was collected at 12, 20, 28
and 36 weeks gestation.
-7-
Pregnancy physical activity questionnaire (PPAQ; [20]). This is a self-report
instrument which measures the time spent participating in 32 activities including
household/caregiving, occupational, sports/exercise, transportation, and inactivity.
The PPAQ is reliable and valid measure of exercise during pregnancy. Specifically,
the intraclass correlation coefficient for the sports and exercise activity subscale was
0.83, and scores for the sports and exercise subscale correlate moderately with
actigraph data [20].
From the PPAQ, we extracted data for sports and exercise activities only. The types of
sports and exercise activities assessed in the PPAQ include walking, jogging, prenatal
exercise classes, swimming and dancing. To calculate weekly energy expenditure
using the PPAQ, the duration of time spent in these exercise activities was multiplied
by specific intensities (i.e. MET values) and scores are expressed as MET-hours per
week.
In order take into account the womens weight, which can greatly affect energy
expenditure, weekly kilocalories (kcals) expended by the women during exercise was
calculated. Weekly kcals at each time point were derived by multiplying MET-hours
per week by weight (kg). Because the data was severely skewed, it was converted into
categorical outcome variables at each time point. Because there are no recommended
cut-offs, we chose the cut-point of 900 kcal/wk based the results of prior exercise
intervention delivered to non-pregnant, obese individuals [21]. Thus, at each time
point, women who achieved < 900 kcal/wk were classified as Non-exercisers and
women who achieved > 900 kcal/wk were classified as Exercisers.
-8-
Predictor Variables
Background information. A semi-structured interview was used to collect information
on maternal sociodemographic, obstetric, and health and health behaviour
characteristics. The womans height was measured at this interview and using self-
reported pre-pregnancy weight, pre-pregnancy BMI was calculated.
Pregnancy symptoms. Women were asked to describe their pregnancy symptoms at
12, 20, 28 and 36 weeks. Based on womens qualitative descriptions of their
symptoms at each time point, separate dichotomous variables were created for
nausea/vomiting and fatigue. For each symptom, women who reported having had the
symptom were coded as Yes, and women without this symptom were coded as
No.
The number of symptoms reported by women was also used to create variables
showing the total number of symptoms reported at each time point. These variables
were categorised as: 0-1; 2-3; 4 or more.
Low back pain. The Roland-Morris Disability questionnaire (RDQ-24) is a self-report
questionnaire assessing the level of physical disability resulting from low back pain.
The questionnaire contains 24 statements describing symptoms of low back pain, and
individuals are asked tick only those statements which apply to them on the day of
completion. Total scores range from 0 to 24, with higher scores indicating greater
disability. The RDQ-24 has been shown to be a reliable measure of low back pain that
has been validated in a number of populations and countries. Internal consistency for
the scale is good with Cronbachs alpha ranging from 0.84 to 0.93[22].
Statistical Analysis
All analyses were conducted using STATA version 10.0 (StataCorp, Texas, USA).
Univariate differences between the groups on the sociodemographic, obstetric,
-9-
physical and mental health and health-related variables, and pregnancy symptoms,
were examined using chi-square tests for independence and Fishers exact tests for
categorical variables, and unpaired t-tests for continuous variables. Women were
included in the analyses at each time point if they had data on the PPAQ.
Results
Participant Characteristics
The mean age of the sample (n=50) was 30 5yrs and slightly more than half of
women were married and had at least one child (Table 1). Most women (74%)
reported being in either part-time or full-time employment at 12 weeks gestation and
30% were tertiary educated. Almost one fifth of women had a history of miscarriage
and 26% had had a previous caesarean section. The median pre-pregnancy weight was
90kg and 36% of women had a BMI greater than 35 kg.m
-2
, but smoking rates were
relatively low (6%). At 12 weeks gestation, nausea and fatigue affected 78% and 54%
of women, respectively. Back pain affected 6% of women at 12 weeks and increased
to 30.5% at 36 weeks gestation. Characteristics of the women according to their group
allocation in the randomised control trial have been published elsewhere [17].
Energy Expenditure
Table 1 shows the proportion of women who were classified as Exercisers and Non-
exercisers. At 12 weeks gestation, the proportion of Non-exercisers (66%) was almost
double that of Exercisers (34%). Therefore, more than half of the women were not
achieving greater than 900 kcal of exercise per week. Athough there was a marked
decrease in the proportion of Non-exercisers at 20 (40%) and 28 (41%) weeks, the
percentage of Non-Exercisers increased to 57% at 36 weeks. Data derived from the
semi-structured interviews with the women conducted as part of the RCT showed that
-10-
walking was the preferred method of exercise over the course of the trial, although a
wide variety of activities were undertaken [23].
Predictors of Exercise in Early Pregnancy
Table 1 shows the selected sociodemographic, obstetric, health and health behaviour
predictors of exercise at 12 weeks gestation for women who were classified
Exercisers and Non-exercisers. Pre-pregnancy weight and a history of previous
miscarriages were associated with exercise status. Exercisers were more likely to have
a lower pre-pregnancy weight (z = 2.74, p = 0.006) and a history of miscarriage than
non-exercisers (p = 0.047, Fishers exact test). The number of children living at home
was also a determinant of exercise status. At 20 weeks, Exercisers were more likely to
have at least one child living at home than Non-exercisers
2
(df = 1, N = 42) = 4.29, p
= 0.038.
Predictors of Exercise in Late Pregnancy
Educational attainment was a significant predictor of exercise in late pregnancy (see
Table 1). At 36 weeks, women who had completed tertiary education were three times
more likely to be an Exerciser (p = 0.02, Fishers exact test). At 28 weeks, women
who were randomised to the intervention group in the RCT were more likely to be
classified as an Exerciser
2
(df = 1, N = 41) = 3.94, p = 0.047, and there was also a
trend towards Exercisers being slightly younger than the Non-Exercisers (p = 0.09,
Fishers exact test).

Pregnancy Symptoms
Self-reported pregnancy symptoms were associated with exercise status during
pregnancy (Table 2). Specifically, women classified as Exercisers were less likely to
report nausea or vomiting at 28 weeks gestation than Non-exercisers (p = 0.01,
-11-
Fishers exact test). Differences between the Exercisers and Non-exercisers were also
found for low back pain. The distributions of low back pain for the Exercisers
and Non-exercisers showed that Exercisers were more likely to report fewer
symptoms of back pain than Non-exercisers (z = 1.99, p = 0. 047). There were no
significant differences between the groups for fatigue and poor sleep at any point
during pregnancy.

Discussion
The aim of the study was to examine the correlates of exercise among obese women
in early and late pregnancy. Although relevant sociodemographic, health behaviour
variables and pregnancy symptoms were associated with exercise status in this study,
the only obstetric variable to show an association with exercise status was previous
miscarriages. Women who had a history of miscarriage were more likely to be
Exercisers very early in pregnancy. This is likely to reflect the fact that many
pregnant women who have a history of pregnancy loss are anxious about future loss
and may subsequently adopt healthier lifestyles in an attempt to prevent future
miscarriages [24, 25].
Sociodemographic variables, including the number of children living at home and
education were associated with exercise status in this study. We found that women
with at least one child living at home were more likely to be classified as Exercisers,
which is contrary to other evidence showing that women with children at home are
less likely to be physically active [6, 9, 10]. It is possible that the women in our study
with children were also not currently working, or had children who were older and in
school. This may have allowed the women to have more time to exercise accounting
for our findings. We found that education was a predictor of exercise status in late
-12-
pregnancy. Consistent with previous findings [6, 8, 9, 26], women classified as
Exercisers were more likely to have completed tertiary education than Non-
exercisers. Our findings are not unexpected considering that the link between obesity
and low socio-economic status has been previously established [27]. Social
disadvantage is associated with a range of poor health behaviours, and thus obese
pregnant women who come from disadvantaged backgrounds may benefit from
greater intervention. Pre-conception counselling may be particularly important for this
group of women. However, low socio-economic status is generally associated with
poor access to health services and this, in combination with the low rates of planned
pregnancies [28], suggests that community-based interventions for these women may
need to be considered as a feasible alternative. The fact that women assigned to the
intervention group in the RCT were more likely to be classified as Exercisers in late
pregnancy suggests the importance of providing support for obese pregnant women to
facilitate long-term health behaviour change.
Pregnancy symptoms were also associated with exercise status during pregnancy.
Women who reported lower back pain at 12 and 20 weeks and nausea or vomiting at
20 and 28 weeks were less likely to be classified as Exercisers. These findings are
consistent with other evidence suggesting that exercise in early pregnancy is related to
decreased reporting of nausea and vomiting in late pregnancy.[12] However, the
direction of the relationship between these pregnancy symptoms and exercise in our
study was not clear. The findings may suggest that exercise helps alleviate nausea and
vomiting in pregnancy. Alternatively, women may have chosen to exercise because
they experienced less nausea or vomiting during their pregnancy. In this study we
found physical health differences between the Exercisers and Non-Exercisers.
Specifically, pre-pregnancy weight in the Exercisers was lower at 12 weeks gestation
-13-
than in the Non-exercisers. The differences between the groups for back pain found in
early pregnancy also support this, and are consistent with evidence suggesting that
pre-pregnancy physical activity is associated with a reduced risk of back pain during
pregnancy.[14] Further work is required to determine if this is a causal relationship.
In our study, it is unclear whether women who have less back pain are more likely to
exercise, or whether women who do exercise benefit from a reduction in back pain.
A major issue with lifestyle interventions is the assessment of physical activity. Both
subjective and objective measures of physical activity have well known limitations
(27). The PPAQ was very useful measure in our study easy to complete and tailored
to measure physical activity among women during pregnancy. The self-report nature
of the questionnaire meant that we relied on the women to accurately recall their
activity, and this may have led to an overestimation of exercise hours. Thus, our
results may not generalise to other studies, particularly those relying on objective
measures of exercise.
In the RCT, a number of women withdrew from the trial at different stages, limiting
the data that was available for analysis over the course of the trial. A total of five
women (n = 3, control; n = 2, intervention) dropped out soon after their baseline visit.
Three women withdrew from the trial when they discovered they had been
randomised to the control group and were disappointed with this outcome. Two
women who were randomised to the exercise arm also withdrew at 12 weeks when
they were diagnosed with gestational diabetes based on their baseline blood tests.
Among the remaining women, those that withdrew from the study (n = 4, control; n =
5, intervention) did so because of medical or obstetric complications (e.g. miscarriage,
intrauterine fetal death, sacroiliac joint instability, gestational diabetes); five women
delivered before 36 weeks and thus did not have data collected at 36 weeks. The
-14-
retention rates in the RCT and the reasons for non-completion have been published
elsewhere [18].
The small sample size in our study limited our ability to adjust for other variables,
including age and pre-pregnancy BMI. The women who remained in the study may
represent a highly motivated group, which may limit the extent to which these results
generalise. The results of this small pilot study suggest that it may be important to
adjust for sociodemographic variables (e.g. age, education), as well as pre-pregnancy
BMI in future analyses examining the correlates of exercise in pregnancy.
Conclusions
This is the first study to identify the correlates of exercise during pregnancy in an
obese population. We found that health-related variables tended to predict exercise in
early pregnancy whereas sociodemographic variables were most likely to predict
exercise in late pregnancy. Specifically, women who had a history of miscarriage; a
lower pre-pregnancy BMI; who reported no nausea and vomiting; and who had no
lower back pain, were those women who were most likely to have exercised in early
pregnancy. Exercise in late pregnancy was most common among women who were
better educated, and there was a trend for younger women to be classified as
Exercisers during the third trimester of pregnancy. However, the direction of the
relationship between exercise and pregnancy symptoms is unclear and requires further
examination using larger samples prospectively designed to answer these questions.
The findings may be particularly useful for researchers who are designing
interventions aimed at reducing or controlling weight gain in obese pregnant women.
Interventions that offer greater support to women from disadvantaged backgrounds,
and closer monitoring of women who report persistent nausea and vomiting or lower
-15-
back pain during pregnancy may be beneficial. Providing this care and support may
be an initial step towards increasing obese womens participation in exercise during
pregnancy.
-16-
Competing interests
None
Authors Contributions
KFF: Has been involved in design of the study, data collection, analysis and drafting
the manuscripts. IJR has made substantial contributions to the statistical analysis of
data and drafting of the manuscript. NMB has been involved in interpretation of the
data and revising the intellectual content. HDM was involved in study design and
revision of the intellectual content. LKC has been involved in the design of the study,
obtained funding, provided oversight of the data collection and data analysis and
revision of the intellectual content. All authors have read and approved the final
manuscript.
Authors information
KFF: RN, Research Midwife.
IJR: BPsycSc(Hons), PhD. Postdoctoral Research Fellow at University of Queensland
and Queensland Institute of Medical Research.
NMB: BHMS, MAppSc, PhD.
HDM: MBBS (Hons), FRACP.
LKC: MBBS (Hons), FRACP, PhD.

Acknowledgments:We would like to thank the entire BAMBINO group from the
Royal Brisbane and Womens Hospital, Brisbane, Australia, for their contribution to
the project Susie Croaker, Dietitian- Nutritionist, Department of Nutrition and
Dietetics Xanthe Sansome, physiotherapist and research assistant Briony
OConnor, physiotherapist and Ainsley Groves, exercise physiologist, School of
Human Movement Studies, QUT.

We would also like to thank Alison Barry, Dr Karin Lust, Dr Sophie Clarke, Barbara
Waters, Kellie Himstedt, Dr Jon Hyett, and Dr Lynda Gillen for their support and
contribution to the project and the midwives from Maternity Outpatient Department
(MOPD), the birth suite and the labour ward.
Funding
The BAMBINO project was supported by a Royal Brisbane and Womens Hospital
foundation strategic initiative grant.
-17-
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-19-
Tables
Table1. Sociodemographic, health, obstetric, and health behaviour
predictors for women classified, Exercisers and Non-exercisers during
pregnancy
12 wt<' ks' 20 w,..ks' 2S .HtkJ' 36 "'teks'
\',\KI,\8lt: /I 18 ,,"'.l4 /I 17 2.
,'lion- h t ITi!;t r$ Non- En rci $l'l"$ "'on- Eu rciStI'1 Non-
heiStrs htrdstrs herl'i !>t1'S .:. t rdstrs
RC I" study group
CQ1Ilrol 18 (550/0) 7(41%) 10 (63%) 9(38%) 11 (65%) 8(33%) I1 (S5Y. ) 5 (330/0)
Imen 'en/ion 15{4S0/0) 10(590/0) 6(38%) 15(630/.) 6 (350/. ) 16 (67%) 9(450/0) 10 (670/0)
P
0.31' 0,12'
0.1)47)
0.20'
Age M (SIl ) 30.0(5.7) 30.5 (4.1) 29.6 (5. 4) 30.3 (5.2) 31.9 (4.5) 29. 1 (5.4) 29.4 (H) 32.1 (U)
P
039 0.10 0.09 0.12
THli Rry 10 (JW. ) 5 (3W. ) 4(22%) II (46%) 5 (290/0) 10 (42%) 4 ( IWo) 9 (600/0)
P
0.95 ' 0,42' 0.02'
Mari lal Slarus
Married 24(730/0) 9(53%) 10(56%) 17 (71%) 9 (530/0) 17 ( 71 %) 13 (62%) 10 (67"/0)
P
0,16' 0.31' 0.77'
24(730/0) 13 (7Wo) 16 (89-/ 0) 17(710/0) 17 (81 %) 18(86%) I1 (73%)
P
0,77) 0,2<r 0.11 ) 0.42)
1 r hild a t humt 18 (55%) 12 (7 1%) 7 (39%) 17(81%) 8 (47%) 16 (67%) 14 (67"4 ) 9 (6O'ro)
P
027)
0.038' 0.21' 0.68'
Pn-"ious 3 (9-10) 6 (35%) 1(6%) 6\25%) 1 (6%) 6(25%) 3 (140/0) 4 (270/0)
misurriages
p 0,21 0.21 0.42
1'rn iuus catprnn 8 (24%) 5 3(17%) 7(33%) 3(180/0) 7 (29%) 3( 14%) 6(40%

p
0,69' 030' 0.48' 0.12'
SmokH 3(9%) 0(00/0) 2( 11%) 1 (4%) 2 ( 120/0) 0 (0%) 2(10%) 0(0%)
, 0,54' 0,57) 0. 17) 0.50
1
Prf-p rf'gna nfY 93(75176) 85 (6895) 92 (75176) 87.5(68 93(681 76) 87.5 (78 93(68 175) 89 (78.2
"right 105) 115) 176)
P
0.0 11 0.3]1 0.48
1
0.521
ll iSlOr)' oFmt nlal 11 (33%) 8(47%)
hea lt h diagnostS
7 (39%) 8(33%) 6(35%) 8 (33%) 9(43%) 4 (270/0)
P
034' 0, 71' 0.89' 0.32'
Note. IChi -sqaure test. lMann-Whitney lest. Data for pre-pregnaney weight is
presented as: Median (range). 3Fisher's exaet test. 4Numbers may not sum to total
beeause some data missing
-20-
-21-

V,\RI,\UI..:
Table 2. Number of pregnancy symptoms: nausea, vomiting, fatigue, low
back pain during pregnancy in PPAC Exercisers versus PPAQ Non-
exercisers
11 .. ....... 20 .. ....... 23 .. ..... .16 ............
,._17
1f I8
.U
,, 17
,._u
,, 21
Or s,' mpl0m. "oR-t: ,e",i>t'" t: ,t"';"-" h ...,i>t", ,",on_.: ,.",i ... ", .:..",;,-",
,-, 9(27". ) 4 (24 . ) 5 (28".) 4 (24.) 10(42"'.) 2 (10".) 3 (20".)
,-, 11 (6S.) 10(36 .) 8(33 .) 1(41 '.) 12(SOO.) 14 (70'.) 9(60". )
4 Or moll: 1 (21' 0) 1 (12'! .) 3 (17".) 6(35.) 3 (2(I'Y,)
, 0.72' O. IS'
.,..
0.88'
Sou..a& 3 6(37". ) 8 (44'.) 7(41-.) 1(4%) IWo) 2(13%)

, 0. 136' QClJ3'
'"'"
O.S6S'
" .fig .. 11(65 .) 3 (17".) '1(38'. ) 7(41 '.) 3(m.) 3 (IS'.) 2
, 0.)7' 0. 18' 0.6:1' 1.00'
" ," 32 ,." 16 " ," 14 .ll
,, _ IS
.ll ,, '" 21 ,." 14
n.ok 1 (0-15) 0(0-7) 3 (0- 14) 0(0-10) 1 (0-8) 3 (0-19) 2 (0-24)
, 0.001'>' 0.1l.I' ,.w 0.25'
Nofe. lChi-sqaure test. 2Mann_ Whitney test. Data for back pain is presented as:
Median (range). 3Fisher's exact test. 4 Numbers may not sum to total because some
data missing.
-22-
-23-

88
Appendix 3 Letter of Invitation

Royal Brisbane and Womens Hospital
Health Service District

Division of Medicine, Department of Internal Medicine
Internal Medicine Research Unit

Enquiries to:
Katie Foxcroft
Research Nurse
Phone: 07 3636 5164
Fax: 07 3636 5737

Dear

You are invited to participate in a research project being
conducted at the Royal Brisbane and Womens Hospital.
We are interested in hearing about symptoms women have during
their pregnancy. We will be conducting a couple of informal
discussion groups to record symptoms you may be experiencing
so that we can develop a symptoms inventory or survey that is
relevant to all pregnant women.
We would then like to road test the survey to make sure it is
relevant to pregnant women, well understood and user friendly.
If you are interested in participating in these discussion groups
and currently less than 12 weeks pregnant, we would invite you to
consider participating in this study.
Further information is available by calling me on 36365164.

Regards

Katie Foxcroft

Principal Investigator
89
Appendix 4 Survey of Midwives who used the PSI

Survey of Midwives who used the Pregnancy Symptoms
Survey in MOPD March 2008

Instructions

Please give your answer by putting a vertical line through the
horizontal line.

How useful did you find the Pregnancy Symptoms Survey at
identifying symptoms??

Very
Useful

Did you refer anyone for further assistance eg physio, incontinence
nurse or mental health?
Yes No
(Please circle)

Please make any other comments or suggestions for improvement.
(Optional)
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
91
Appendix 5 Inventory completed by women included
in the study
94
Appendix 6 Permission from the Ethics Committee
, '
Queensland
Government
Royal Brisbane & Women's Hospital & Health Service District
Ofice of the Human Research Ethics Committees
30 November 2006
Ms Katie Foxcroft
Commercial Studies Coordinator
Internal Medicine Research Unit
RBWH
Dear Ms Foxcroft
Queensland Health
Enquiries to: Coordinator
Phone: 07 3636 5490
Fax: 07363678 00
Our Rei: 20061125
E-mail RBWH-Ethics@health.qld.
gov.au
PROTOCOL 2006/125: DEVELOPMENT AND VALIDATION OF A PREGNANCY SYMPTOMS
INVENTORY
At a meeting of the Royal Brisbane & Women's Hospital Human Research Ethics Committee held
on 25 September 2006, the Committee reviewed the above Protocol. The Royal Brisbane &
Women's Hospital Human Research Ethics Committee is duly constituted, and operates and
complies with the National Health and Medical Research Council's 'National Statement on Ethical
Conduct in Research Involving Humans and Supplementary Notes, 1999'. The Chair of the HREC
reviewed your further correspondence on the 27 November 2006.
tt is advised that on the recommendation of the Human Research Ethics Committee, the Clinical
Chief Executive Officer, Royal Brisbane & Women's Hospital has approved your request for ethical
approval of the following:
Protocol V1. 1 dated 2410812006
PICF V2 dated 1611112006

Recruitment Letter
NEAF dated 10111106

During the conduct of the study you are required to adhere to the following conditions:
If recruitment has not commenced within 12 months, please advise the Coordinator, HREC.

All forms required when submitting reports to the HREC are accessible on the Herston Intranet. In
the first instance please access the Commencement Form and return to this office when the study
commences. Please contact the Coordinator if you do not have access to this site.
In accordance with RBWH Policy 72005: Clinical Trial Documentation, all medical records of
research participants must contain documentation regarding the patient's involvement in the trial.
All investigations must be carried out according to the "Declaration of Helsinki 2000" as
subsequently modified and the latest statement by the National Health and Medical Research
Council on Human Experiments and on Scientific Practice. Should a copy of the 'Declaration of
Helsinki 2000' as subsequently modified be required, please request a copy from the Coordinator,
Human Research Ethics Committee.
Attachment I is a letter listing some matters specified by the National Health and Medical
Research Council to which you as the research worker must adhere.
Ofice
Herston Rd
Herston Q 4029
Postal
Post Ofice Herston
Queensland 4029 Australia
Phone
0736365490
ISD + 61 7 3636 5490
Fax
0736367800
Attachment 11 gives the Committee composition with specialty and affiliation with the Royal
Brisbane & Women's Hospital.
You are required to provide a report on any pilot study and the outcome of the study at the
completion of the trial or annually if the trial continues for more than 12 months.
If any subsequent change/amendment is made to the protocol it will be necessary for you to
obtain approval from the Human Research Ethics Committee. In addition a summary of the
amendments and a comment is required from the Principal Investigator. All amended documents
must contain revised version numbers, version dates and page numbers. Changes must be
highlighted using Microsoft Word "Track Changes" or similar. Please contact the HREC
Coordinator if assistance is required.

Serious Adverse Events must be notified to the Committee as soon as possible. In addition the
Investigator must provide a summary of the adverse events, in the specified format, including a
comment as to suspected causality and whether changes are required to the Patient Information
and Consent Form.
If the results of your protocol are to be published, an appropriate acknowledgment of the Hospital
should be contained in the article. Copies of all publications resulting from the study should be
submitted to the Human Research Ethics Committee.
Please ensure that a copy of any publication that results from this protocol is also forwarded to the
Herston Medical Library for future reference.
The Hospital administration and the Human Research Ethics Committee may inquire into the
conduct of any research or purported research, whether approved or not and regardless of the
source of funding, being conducted on hospital premises or claiming any association with the
Hospital; or which the Committee has approved if conducted outside the Royal Brisbane &
Women's Hospital Health Service District. This may include consultation with the Principal
Investigator and/or a visit to the research site by a member of the HREC and/or Coordinator of
the HREC.
Should you have any problems, please liaise directly with the Chairperson of the Human Research
Ethics Committee early in your program.
We wish you every success in undertaking this research.
Yours faithfully
FM ;j?
for Clinical CEO
Royal Brisbane and Women's Hospital
Health Service District
Ofce
Herston Rd
Hers!on Q 4029
Postal
Post Ofice Herston
Queensland 4029 Australia
Phone Fax
0736365490 0736367800
ISD + 61 7 3636 5490
97
Appendix 7 Participation Information and Consent
Form
101
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Development and Validation of a Pregnancy

Department of Internal Medicine, Royal Brisbane and Womens Hospital, Brisbane,

Queensland Institute of Medical Research and School of Population Health,

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