Cross-sectional study of gestational weight gain and

perinatal outcomes in pregnant women at a tertiary care

center in southern India
Usha Radhakrishnan
1
, Geeta Kolar
1
and Praveen K. Nirmalan
2
1
Department of Fetal Medicine and Ultrasonography and
2
Clinical Research Unit, Fernandez Hospital, Hyderabad, India
Abstract
Aim: The aim of this study was to determine maternal and neonatal outcomes of less than recommended or
excess gestational weight gain (GWG) based on the recommended Institute of Medicine (IOM) guidelines.
Material and Methods: Using a cross-sectional study design, GWG was assessed for 1462 pregnant women
presenting to a tertiary care perinatal institute in India. Body mass index at baseline, co-existing morbidities,
fetal growth, details of delivery, and maternal and fetal outcomes were determined and documented. Appro-
priate GWG for each woman was determined based on the revised IOM guidelines. Outcome measures
included the proportion of pregnant women compliant with IOM guidelines for GWG and associations of less
than recommended or excess GWG with maternal and neonatal outcomes.
Results: A total of 547 (37.41%, 95% condence interval [CI]: 34.9639.92) pregnant women gained less than
recommended and 313 (21.41%, 95%CI: 19.3623.57) pregnant women gained more than the recommended
weight. Preterm deliveries were associated with less than optimal weight gain (adjusted odds ratio 3.58,
95%CI: 1.757.32) after adjusting for gestational age at delivery. GWG was not associated with neonatal
outcomes in this population.
Conclusions: The lack of associations with perinatal outcomes indicates that the IOM guidelines may not be
the appropriate standard for monitoring GWG in this population.
Key words: body mass index, gestational weight gain, Institute of Medicine guidelines, perinatal outcome,
pregnancy.
Introduction
The Institute of Medicine (IOM) guidelines developed
in 1990 recommended a maternal weight gain of 2535
pounds for women with normal weight for height to
optimize fetal growth and maternal/infant outcomes.
1
Many key aspects of the reproductive health of women
of child-bearing age have since changed, especially
increasing advanced maternal age, a rising prevalence
of obesity, diabetes, hypertension and other chronic
non-communicable diseases, prompting a revision of
the IOM guidelines in 2009.
2
The revised recommenda-
tions provide a specic range of weight gain for over-
weight and obese women that was previously lacking.
The wide acceptance and adoption of the IOM guide-
lines has not, however, translated into optimal gesta-
tional weight gain (GWG) with studies reporting that
37% of normal-weight women and 64% of over-
weight women gain more than IOM recommenda-
tions.
3,4
GWG that exceeds the IOM recommended
levels is associated with complications in delivery
(cesarean section deliveries), large-for-gestational-age
Received: September 24 2012.
Accepted: February 27 2013.
Reprint request to: Dr Geeta Kolar, Department of Fetal Medicine and Ultrasonography, Fernandez Hospital, Hyderabad 500001,
India. Email: geetkolar@gmail.com; drgeeta@fernandezhospital.com
bs_bs_banner
doi:10.1111/jog.12115 J. Obstet. Gynaecol. Res. Vol. 40, No. 1: 2531, January 2014
2013 The Authors 25
Journal of Obstetrics and Gynaecology Research 2013 Japan Society of Obstetrics and Gynecology
(macrosomic) babies, obesity in offspring by age 3
years, greater postpartum weight retention and an
increased risk of being overweight in the future, and
may co-exist with other maternal lifestyle diseases like
hypertension and diabetes.
515
The National Family Health Survey-III from India,
which includes the health of women of child-bearing
age, reports that 33% of women have a body mass
index (BMI) below normal, 14.8% of women are over-
weight or obese and 57.9% of pregnant women are
anemic.
16
Appropriate GWG may help optimize
maternal and fetal outcomes in pregnant women who
may be undernourished at conception. To the best of
our knowledge, there is little or no information from
India on GWG, the adherence to or usefulness of the
IOM recommendations for GWG in this population
and the effects of GWG on fetal outcomes and mater-
nal health. The current study was designed to deter-
mine the distribution of adherence of GWG to the
IOM recommendations and its appropriateness in a
population of pregnant women booked for antenatal
care at a tertiary care perinatal institute in southern
India.
Methods
The study was initiated after the study protocol was
approved by the Institutional Review Board of the
study institute, which is an advanced tertiary care peri-
natal teaching institute that carries out approximately
5000 deliveries each year. Pregnant women aged 18
years or older, booked for antenatal care at the study
institute prior to 22 gestational weeks with the gesta-
tional age conrmed by ultrasound dating and with a
singleton fetus were considered as eligible for inclu-
sion in the study. Pregnant women who did not meet
the inclusion criteria and pregnant women whose
maternal health necessitated termination of pregnancy
prior to 25 gestational weeks or did not provide
informed consent were excluded from the study.
Written informed consent was obtained from each par-
ticipant prior to recruitment.
Details of antenatal care at the study institute, based
on standardized clinical care protocols, were initially
entered into a medical case record and subsequently
transferred into an electronic database. Maternal and
neonatal morbidity were identied and documented
using standard clinical denitions and categories.
Every pregnant woman was assessed for height using a
measuring tape, weight using a calibrated electronic
weighing machine, blood pressures in the seated posi-
tion, medical, surgical and obstetric history, personal
risk behavior and nutrition assessments. Baseline
investigations included, but were not limited to, hemo-
globin, blood sugar levels (including a 2-h 75-g oral
glucose tolerance test between 24 and 28 weeks of ges-
tation based on the International Association of the Dia-
betes and Pregnancy Study Groups [IADPSG] criteria),
screening for thyroid disorders and trimester-specic
ultrasound exams. The BMI for each woman was esti-
mated as the weight in kg divided by height in m
2
. The
weight gain during each trimester was assessed at
2024 weeks and at 3035 weeks using the same weigh-
ing machine. The presence of medical co-morbidities,
gestational age at delivery, details of delivery (includ-
ing mode of delivery and complications associated
with delivery) and neonatal outcomes were routinely
recorded. Consistent with the IOM guidelines, a
BMI < 18.5 kg/m
2
was considered as lean, 18.5
24.9 kg/m
2
as normal, 2529.9 kg/m
2
as overweight
and 30 kg/m
2
or above as obese. The IOM guidelines
(revised in 2009) developed for the US population rec-
ommends a GWG of 12.518, 11.516, 711.5 and
59 kg as appropriate for women with pre-pregnancy
BMI considered as lean, normal, overweight and obese,
respectively.
2
Overweight and obese pregnant women
and women with gestational diabetes or diabetes mel-
litus were referred for nutritional counseling as part of
routine antenatal care. However, pregnant women
with a lean pre-pregnancy BMI were sent for nutri-
tional counseling based on the discretion of the treating
clinician.
Fetal growth was assessed through serial ultrasound
measurements by trained sonologists. The Voluson
with curved array transabdominal transducer AB
27 MHz with multihertz and harmonic capability and
HP machine with transabdominal probe was used for
the ultrasound exams with images stored in digital
imaging media. These images were available for retro-
spective assessment and re-measurement of all fetal
parameters as needed. The rst-trimester scan was
done at 1113
+6
weeks of gestation for nuchal translu-
cency and dating of gestational age by measuring
crownrump length. The second-trimester targeted
imaging for fetal anomalies scan was done at 1924
weeks of gestation. Dating of pregnancy was done
during this period if it was not done earlier. The third-
trimester scan (fetal well-being scan) was done at 3035
weeks of gestation and the growth of the fetus was
plotted on the population-based growth curves. The
biparietal diameter, head circumference, abdominal
U. Radhakrishnan et al.
26 2013 The Authors
Journal of Obstetrics and Gynaecology Research 2013 Japan Society of Obstetrics and Gynecology
circumference, and femur length taken using standard
planes of ultrasound were considered and used as a
combination of these variables to derive an estimated
fetal weight and growth pattern of the given fetus.
Population-based growth curves (from Sonocare soft-
ware developed by Mediscan systems at Chennai) for a
south Indian population were used to determine the
type of fetal growth. Fetuses whose growth parameters
were in between the 5th and 95th centiles were consid-
ered as average for gestational age, fetuses whose
growth parameters were on the 95th centile or above
were considered as large for gestational age and fetuses
whose growth parameters were on the 5th centile
or lower were considered as small for gestational
age.
The Open Epi-Epidemiologic Calculator was used to
estimate a sample size of 1015 pregnant women based
on a two-sided signicance level (1-alpha) of 95% and
a hypothesized frequency of inappropriate GWG
(greater than or lower than recommended weight gain
guidelines) of 70 5% in an estimated 5000 annual
deliveries at Fernandez Hospital.
17
A potential dropout
rate of 30% was considered to further revise the esti-
mated sample size to 1320 pregnant women.
Statistical analysis was performed using stata statis-
tical software (version 9.0). The distribution and the
95% condence intervals (95%CI) around the point
estimates for women who had optimal, less than rec-
ommended or more than recommended GWG based
on the IOM guidelines were determined. The distribu-
tion of gestational medical co-morbidities, mode of
delivery and complications, and neonatal outcomes
were compared between the three groups. The c
2
-test
or Fishers exact test were used to compare categorical
variables and a one-way anova test was used to
compare continuous variables. A multivariate logistic
regression model (that adjusted for factors found sig-
nicant in a bivariate analysis) was used to explore
associations of the different GWG categories with
maternal and neonatal outcomes. A P-value < 0.05 was
considered as statistically signicant.
Results
The study included 1462 pregnant women booked at
Fernandez Hospital for antenatal care from June 2010
to April 2011. The mean (standard deviation) age of
study participants was 27.30 (4.27) years (range 1844
years). The mean (standard deviation) weight gain
during pregnancy was 10.51 (4.46) kg (range 128 kg).
An optimal weight gain based on the IOM recommen-
dations was present for 602 (41.18%, 95%CI: 38.67
43.72) of the pregnant women. A total of 547 (37.41%,
95%CI: 34.9639.92) pregnant women gained less than
recommended and 313 (21.41%, 95%CI: 19.36, 23.57%)
pregnant women gained more than the recommended
weight. Table 1 presents the characteristics of the 1462
pregnant women in the study stratied by GWG.
The distribution of maternal and neonatal outcomes
with GWG is presented in Tables 2 and 3, respectively.
Preterm deliveries (<37 weeks of gestation) were sig-
nicantly more common in women with less than
optimal weight gain (see Table 2). Gestational hyper-
tension was less common in women with less than
optimal weight gain; however, this difference was not
statistically signicant (see Table 2). Babies born to
mothers with less than optimal weight gain had sig-
nicantly lower mean birthweights (see Table 3) and
were more likely to be low birthweight (<1.5 kg)
although this association was not statistically signi-
cant. Babies born to mothers with more than optimal
weight gain were signicantly more likely to be large
for gestational age (see Table 3). In a multivariate
regression model that adjusted for age of mother,
parity, gestational age at delivery and BMI, preterm
deliveries were signicantly associated (adjusted odds
ratio 3.58, 95%CI: 1.757.32) with less than optimal
weight gain in pregnancy (see Table 4). Gestational
weight gain, categorized as per the revised IOM guide-
lines, was not signicantly associated with other mater-
nal or neonatal outcomes.
Discussion
The results of the study indicate a lower than optimal
adherence in this population to the IOM recommen-
dations for appropriate GWG. Overall, more than one
in three pregnant women gained less than the recom-
mended weight and one in ve pregnant women
gained more than the recommended weight during
pregnancy. In this study, 59.07% of pregnant women
with a lean BMI at baseline gained less than recom-
mended weight and 36.24% and 29.27% of over-
weight and obese pregnant women gained more
than the recommended weight during pregnancy.
Lower than optimal weight gain was associated with
increased preterm births and lower mean birth-
weights, even after adjusting for gestational age at
delivery. However, it is possible that the less-than-
optimal weight gain and lower birthweights were an
effect rather than cause of prematurity.
Gestational weight gain
2013 The Authors 27
Journal of Obstetrics and Gynaecology Research 2013 Japan Society of Obstetrics and Gynecology
Consistent with previous studies, it was found that
women with gestational diabetes gained less than rec-
ommended weight during pregnancy.
18,19
It is possible
that the lower-than-recommended weight gain is
attributable to stricter nutritional counseling when we
consider that the majority (86.03%) of pregnant women
with gestational diabetes in this study were on a com-
bination of diet control and exercise. The association of
hypertensive disorders in pregnancy with more-than-
recommended weight gain is consistent with available
knowledge, although our study design does not allow
us to comment on a cause-and-effect correlation.
18,20
The inuence of edema and uid retention on mea-
sured weight in hypertensive disorders of pregnancy
needs further study. Similar to other studies, more-
than-recommended weight gain during pregnancy was
associated with an increased incidence of operative
deliveries through a cesarean section.
2,6
Maternal weight gain more than the IOM recom-
mendations has been reported with an increased risk of
Table 1 Characteristics of the 1462 pregnant women included in the study
Characteristics Optimal weight gain
(n = 602)
Less-than-optimal
weight gain (n = 547)
Excess weight gain
(n = 313)
Total
(n = 1462)
Lean BMI at baseline 35 (33.33%) 62 (59.05%) 8 (7.62%) 105 (7.18%)
Optimal BMI at baseline 277 (40.26%) 337 (48.98%) 74 (10.76%) 688 (47.06%)
Overweight BMI at
baseline
217 (42.97%) 105 (20.79%) 183 (36.24%) 505 (34.54%)
Obese BMI at baseline 73 (44.51%) 43 (26.22%) 48 (29.27%) 164 (11.22%)
Previous cesarean
section
128 (21.26%) 134 (24.50%) 56 (17.89%) 318 (21.75%)
Chronic hypertension 13 (2.16%) 18 (3.29%) 5 (1.60%) 36 (2.46%)
Diabetes mellitus 8 (1.33%) 18 (3.29%) 11 (3.51%) 37 (2.53%)
Prior hypothyroid 53 (8.80%) 42 (7.68%) 28 (8.95%) 123 (8.41%)
Prior renal disease 12 (1.99%) 8 (1.46%) 8 (2.56%) 28 (1.92%)
Prior CVS disease 2 (0.33%) 9 (1.65%) 2 (0.64%) 13 (0.89%)
Primigravida 266 (44.19%) 170 (31.08%) 147 (46.96%) 583 (39.88%)
Nulliparous 333 (55.32%) 223 (40.77%) 202 (64.54%) 758 (51.85%)
Pre-eclampsia 21 (3.49%) 17 (3.11%) 13 (4.15%) 51 (3.49%)
Eclampsia 4 (0.66%) 2 (0.37%) 1 (0.32%) 7 (0.48%)
Gestational hypertension 17 (2.82%) 9 (1.65%) 14 (4.47%) 40 (2.74)
Gestational diabetes 137 (22.76%) 143 (26.14%) 78 (24.92%) 358 (24.49%)
Screen hypothyroid
(detected during
antenatal care)
25 (4.15%) 30 (5.48%) 13 (4.15%) (4.65%)
BMI, body mass index; CVS, cardiovascular system.
Table 2 Maternal outcomes and gestational weight gain
Maternal outcomes Optimal weight
gain (n = 602)
Less-than-optimal
weight gain
(n = 547)
Excess weight
gain (n = 313)
P-value*
Preterm (<37 weeks) 54 (8.97%) 96 (17.55%) 25 (7.99%) <0.001
Postpartum hemorrhage 11 (1.83%) 3 (0.55%) 5 (1.60%) 0.14
Cesarean section 255 (48.76%) 221 (45.38%) 155 (54.96%) 0.04
Assisted vaginal delivery 79 (22.77%) 59 (18.15%) 29 (18.59%) 0.28
Preterm premature rupture of membranes 16 (2.89%) 13 (2.57%) 6 (2.17%) 0.83
Premature rupture of membranes 48 (8.19%) 41 (7.69%) 37 (12.05%) 0.08
Pre-eclampsia 21 (3.70%) 17 (3.28%) 13 (4.44%) 0.70
Eclampsia 4 (0.73%) 2 (0.40%) 1 (0.36%) 0.69
Gestational hypertension 17 (3.01%) 9 (1.76%) 14 (4.76%) 0.05
Gestational diabetes mellitus 137 (23.06%) 143 (27.03%) 78 (25.83%) 0.29
Screen-detected hypothyroid 25 (4.58%) 30 (5.94%) 13 (4.58%) 0.54
*P-values determined using the c
2
-test and Fishers exact test. Fishers exact test was used where category counts were <5. A P-value < 0.05
was considered as signicant. Denominator includes those categorized as normal for that category.
U. Radhakrishnan et al.
28 2013 The Authors
Journal of Obstetrics and Gynaecology Research 2013 Japan Society of Obstetrics and Gynecology
neonatal complications like macrosomia, hypoglyce-
mia and hyperbilirubinemia (jaundice).
21
Jaundice and
hypoglycemia in neonates were more common in
women with excess weight gain; however, neonatal
outcomes did not vary signicantly across BMI catego-
ries after stratication by pre-pregnancy BMI. The
number of stillbirths and perinatal deaths was not
sufciently large enough to explore for any statistical
Table 3 Neonatal outcomes and gestational weight gain categories
Neonatal outcomes Optimal weight
gain (n = 602)
Less-than-optimal
weight gain (n = 547)
Excess weight
gain (n = 313)
P-value*
Mean birthweight in kg 2.99 (0.49) 2.79 (0.56) 3.07 (0.51) <0.001
Low Apgar at 5 min 5 (0.84%) 2 (0.37%) 1 (0.32%) 0.47
Stillborn 5 (0.83%) 6 (1.1%) 2 (0.64%) 0.77
Neonatal death 2 (0.33%) 2 (0.37%) 2 (0.64%) 0.77
Small for gestational age 30 (5.44%) 31 (6.05%) 11 (4.09%) 0.51
Large for gestational age 51 (8.92%) 35 (6.78%) 44 (14.57%) 0.001
Birthweight < 1.5 kg 7 (1.16%) 17 (3.11%) 5 (1.60%) 0.05
Jaundice 286 (47.51%) 254 (46.44%) 163 (52.08%) 0.26
Sepsis 27 (4.49%) 31 (5.67%) 9 (2.88%) 0.17
Congenital anomalies 18 (2.99%) 22 (4.02%) 9 (2.88%) 0.54
Hypoglycemia 9 (1.50%) 10 (1.83%) 10 (3.19%) 0.21
Respiratory distress 18 (2.99%) 27 (4.94%) 9 (2.88%) 0.15
Birth asphyxia 5 (0.83%) 3 (0.55%) 0 (0.00%) 0.27
*P-values were determined using the c
2
-test and Fishers exact test for categorical variables and one-way anova test for continuous variables.
Fishers exact test was used where category counts were <5. A P-value < 0.05 was considered signicant. Denominator includes those
categorized as normal for that category.
Table 4 Multivariate logistic regression model for associations of gestational
weight gain with maternal and neonatal outcomes
Maternal outcomes Less-than-optimal
weight gain
Adjusted OR
(95%CI)
Excess weight gain
Adjusted OR
(95%CI)
Preterm (<37 weeks) 3.58 (1.757.32) 0.42 (0.141.25)
Cesarean section 0.82 (0.471.44) 1.56 (0.862.82)
Assisted vaginal delivery 0.75 (0.421.31) 1.03 (0.442.36)
Preterm premature rupture of
membranes
0.5 (0.131.87) 2.25 (0.4212.08)
Premature rupture of membranes 1.15 (0.572.31) 2.52 (1.205.28)
Pre-eclampsia 0.89 (0.401.96) 1.88 (0.724.90)
Eclampsia 0.09 (0.0016.06) 0.58 (0.0122.69)
Gestational hypertension 0.63 (0.261.52) 0.71 (0.252.00)
Low Apgar at 5 min 0.20 (0.021.60)
Stillborn 2.00 (0.1822.05)
Neonatal death 0.59 (0.093.87) 1.00
Small for gestational age 0.99 (0.511.95) 0.52 (0.201.36)
Large for gestational age 0.64 (0.331.25) 1.49 (0.862.60)
Birthweight < 1.5 kg 3.00 (0.5915.01) 0.33 (0.015.96)
Jaundice 0.95 (0.701.30) 1.39 (0.961.99)
Sepsis 1.02 (0.422.45) 1.24 (0.403.84)
Congenital anomalies 1.04 (0.472.30) 0.79 (0.232.63)
Hypoglycemia 0.95 (0.233.78) 3.90 (0.9715.62)
Respiratory distress 1.07 (0.422.75) 0.98 (0.303.16)
Birth asphyxia 0.34 (0.052.23)
Adjusted for age of mother, parity, gestational age at delivery and body mass index,
reference category is optimal weight gain and normal for each category of morbidity. CI,
condence interval; OR, odds ratio.
Gestational weight gain
2013 The Authors 29
Journal of Obstetrics and Gynaecology Research 2013 Japan Society of Obstetrics and Gynecology
signicance. Stillbirths were more common in women
with less-than-optimal weight gain although this may
be associated with preterm deliveries.
Consistent with several other studies, less-than-
optimal weight gain was associated with preterm
deliveries and lower birthweights.
2,6,22,23
However, it is
not possible to suitably comment on causation attribut-
able to less-than-optimal weight gain as data on GWG
by gestational age in weeks was not collected. A strati-
ed analysis of weight gain by gestational age may
provide more information that can support a possible
causal mechanism.
Nearly two-thirds of pregnant women with lean
BMI at baseline had a less-than-optimal weight gain
in this tertiary care center. This statistic is important
when one considers that approximately one in three
women of childbearing age in India has a lean BMI.
16
The study design does not allow us to attribute
reasons for the less-than-optimal weight gain in the
subgroup of women with lean BMI. An exploration
of any potential beliefs or practices pertaining to
reduced obstetrical complications (if GWG was not in
excess) was not performed.
24
The subgroup of preg-
nant women with lean BMI is not prioritized for
nutritional counseling, thus, possibly affecting appro-
priate weight gain.
The study highlights several areas of concern. From
a clinical perspective, it is necessary to develop and
evaluate appropriate GWG criteria in this population
based on associations with maternal and fetal out-
comes. This study shows that the IOM guidelines may
not be appropriate for use in this population as they
were developed on a different population. Addition-
ally, the IOM guidelines are not based on associations
with improved clinical outcomes. The proportion of
women with lean BMI and less-than-optimal weight
gain is a matter of concern in India. Any impact of
appropriate nutritional counseling and adherence to
recommended GWG guidelines on women with lean
BMI and preterm births in this population needs
further study.
The representativeness of the study population to
the general population of southern India is a limita-
tion of the study. The proportion of pregnant women
with lean BMI at baseline in this study is much lower
than the general population and the proportion of
pregnant women that were overweight or obese at
baseline is much higher than the distribution in
the general population.
16
India has recently revised
the BMI cut-offs for Asian Indians
25
with a
BMI > 25 kg/m
2
considered as obese leading to a sub-
stantial increase in the proportion of pregnant women
categorized as obese. A previous study from the study
institute has shown an increase in the prevalence of
obesity from 19.49% to 54.63% when the revised
guidelines are used as the upper limits of what was
previously considered a normal BMI (BMI of 23.0
24.9 kg/m
2
) is now considered as overweight.
25,26
However, there has been no revision of limits for lean
BMI.
25
Obstetricians caring for pregnant Asian Indian
women may need to consider the revised BMI catego-
ries to determine overweight/obese pregnant women
in their clinical practice, although these revised BMI
categories did not consider obstetric outcomes during
their development. The re-categorization necessitates
a change in the appropriate BMI-based GWG guide-
lines that can be applied for Asian Indian women.
A larger study is necessary to develop appropriate
guidelines for GWG by gestational weeks and trimes-
ter. It is possible that the associations we nd might
change in direction and/or strength if we use the
revised BMI categories for India. We could not,
however, test for shifts in associations, as weight gain
guidelines based on the revised BMI categories for
Asian Indians are not available.
The higher incidence of gestational diabetes mellitus
can be attributed to the use of the IADPSG criteria for
the detection of gestational diabetes. The lack of repre-
sentativeness may be attributed to the tertiary care
referral nature of the study institute with nearly 60% of
pregnant women presenting at the institute referred
from other practices. The results of this study may not
be generalizable to the larger community of pregnant
women in southern India.
In conclusion, there is a lower-than-optimal adher-
ence to recommended IOM guidelines for GWG in
this population. Less-than-optimal GWG is associated
with preterm births, even if the pregnant women
are overweight or obese at baseline. The lack of
signicant associations of less than or more than
optimal weight gain with clinical perinatal outcomes
indicates that the IOM standards for GWG may not be
appropriate for this population. Further studies
are required to determine appropriate GWG criteria
for this population based on clinical perinatal
outcomes.
Acknowledgments
Dr U.R. was involved with all aspects of the study
including data collection and writing of the manu-
script, Authors G.K. and P.K.N. were involved with the
U. Radhakrishnan et al.
30 2013 The Authors
Journal of Obstetrics and Gynaecology Research 2013 Japan Society of Obstetrics and Gynecology
design, analysis, interpretation of results and writing of
the manuscript. The manuscript has been read and
approved by all the authors; the requirements for
authorship have been met by all authors; and each
author believes that the manuscript represents honest
work. The study protocol was approved by the Institu-
tional Review Board of Fernandez Hospital, Hydera-
bad through the protocol number EC Ref # 18_2010 R1
and approved on 31 May 2010.
Disclosure
None of the authors have any conict of interest or
nancial disclosures pertaining to this manuscript to
report.
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