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A Comparison of 12- and 24-Hour Urine Albumin Levels

in the Confirmation of Diagnosis of Preeclampsia Among Hypertensive

Pregnant Patients Consulting at a Tertiary Hospital in Manila from

April May 2017

1
ABSTRACT

Hypertensive disorders of pregnancy consist of a broad spectrum of

conditions which are associated with substantial fetomaternal morbidity and

mortality. Hypertensive disorders are the second most common obstetric cause

of stillbirths and early neonatal deaths in developing countries. Preeclampsia is

defined as systolic blood pressure (BP) level of 140mmHg or higher and diastolic

BP of 90mmHg or higher, occurring after 20 weeks of gestation in a woman with

previously normal blood pressure in the presence of albuminuria and/or end

organ damage. The gold standard for quantifying proteinuria is a twenty-four-

hour urine collection but efforts have been done to shorten the period required for

the diagnosis of preeclampsia. This would be valuable for management purposes

as well as for decreasing hospital cost and patient inconvenience. The goal of

this study is to determine the correlation between 12- and 24-hour urine total

protein values to examine whether the 12-hour urine samples could be used for

the diagnosis of proteinuria in hypertensive disorders of pregnancy.

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CHAPTER I

INTRODUCTION

Hypertensive disorders of pregnancy, including preeclampsia, consist of a

broad spectrum of conditions which are associated with substantial maternal and

fetal/neonatal morbidity and mortality (Jeyabalan, A. ,2013). The global incidence

of preeclampsia has been estimated at 5-14% of all pregnancies (Osungbade, K.

O., & Ige, O. K., 2011). In developing countries, the incidence of the preeclampsia

is reported to be 4-18%, with hypertensive disorders being the second most

common obstetric cause of stillbirths and early neonatal deaths in these countries

(Ngoc, N.T. et. al, 2006). In the Philippines, maternal mortality ratio in 2015

remains high at 114 per 100,000 livebirths (CIA, 2015) Furthermore, hypertension

complicating pregnancy, childbirth and puerperium is the 2nd leading cause of

maternal mortality constituting 36.7% (PHS, 2013).

Preeclampsia is defined as systolic blood pressure (BP) level of 140mmHg

or higher and diastolic BP of 90mmHg or higher, occurring after 20 weeks of

gestation in a woman with previously normal blood pressure. It is differentiated

from gestational hypertension by the presence of proteinuria defined as either a

300 mg protein in 24-hour urine specimen, a urine protein: creatinine ratio 0.3;

or persistent 30 mg/dL (1+ dipstick) protein in random urine samples. Furthermore,

preeclampsia can also occur in the absence of proteinuria if there is a new onset

3
of signs and symptoms including thrombocytopenia, renal insufficiency, impaired

liver function, pulmonary edema and cerebral or visual symptoms (ACOG, 2013).

In pregnancy, the gold standard for quantifying proteinuria is a twenty-four-

hour urine collection (Singhal, S. R.,2014). The rationale behind 24-hour collection

is that in preeclamptic patients, fluctuation of protein loss in urine varies

significantly over a 24-hour period and collection of less than this duration may not

accurately reflect the actual amount of daily protein loss (Evans, W.,2000).

Adelberg, et. al in 2001 however noted the drawbacks of these method including

too much time for collection that may lead to incorrect estimation due to improper

collection, improper mixing or spillage which may result in a delay in the diagnosis

and treatment, or possibly the prolongation of hospital stay. Therefore, shortening

the period required for the diagnosis of preeclampsia would be valuable for

management purposes as well as for decreasing hospital cost and patient

inconvenience (Rinehart, B.K et. al.,1999). Efforts are going on to find the shortest

and most reliable time period for urine collection, and few studies have been

carried out in this regard (Rabiee, S., 2007; Amirabi A., 2011). Therefore, the aim

of this study was to determine whether 12-hour urine protein values correlate with

those of 24-hour values in women with preeclampsia.

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SIGNIFICANCE OF THE STUDY

Preeclampsia is a serious complication of pregnancy and its prompt and

accurate diagnosis is essential in the prevention of maternal morbidity and

mortality. Proteinuria is an important symptom of preeclampsia hence the gold

standard for its diagnosis is the 24-hour period collection of urine protein which is

part of the standard antenatal care. However, a 24-hour period required for the

collection of urine may result in the delay of diagnosis and treatment hence result

to prolonged hospital stay. Therefore, shortening the period of timed collection

required for the diagnosis of preeclampsia provide advantages for management

purposes as well as shortened hospital stay and patient inconvenience.

The goal of this study is to determine the correlation between 12- and 24-

hour urine total protein values to examine whether the 12-hour urine samples could

be used for the diagnosis of proteinuria in hypertensive disorders of pregnancy.

Factors were also determined include social demographics including age,

marital status, educational attainment, occupation, financial status and religion as

well as clinical factors such as the patients gravidity and parity. With this

knowledge, this will be vital in the assessment of factors related to preeclampsia.

Management strategies can be developed based on this information as to provide

a good prognosis in patients with preeclampsia. This can also be a basis for health

5
promotion policies to accomplish the millennium development goal of improving

maternal health and the most recent sustainable development goal of achieving

good health and well-being.

RESEARCH OBJECTIVES

General Objective

To determine if 12-hour urine total protein values correlate with the 24- hour value

to confirm the diagnosis of preeclampsia in patients consulting at Ospital ng

Maynila Medical Center from April to May 2017

Specific Objectives

To describe the socio-demographic profile of the pregnant women consulting at

Ospital ng Maynila Medical Center on April to May 2017

To compare the reliability of a 12-hour urine protein to that of a 24-hour urine

protein in the diagnosis of preeclampsia

LIMITATION OF THE STUDY

This study aimed at pregnant women consulting at Ospital ng Maynila

Medical Center Department of Obstetrics and Gynecology who was found to have

features of preeclampsia. And from this population, 12 hour and 24-hour urine

protein collection will be conducted as to determine if both results are comparable

6
in the diagnosis of preeclampsia. Hence, generalizing the results beyond the

intended circumstance shall be avoided.

Prospective studies are less prone to selection bias since the outcome is

unknown at the time of determining the population as is evident in the study.

Furthermore, it does not use standard questionnaires thus information bias

including recall bias and social desirability bias were generally avoided. In the

study, general data as well as socioeconomic and clinical factors were determined.

To avoid response bias, the form was explained in detail with adequate instruction

in filling up the forms of the respondents. The proponent is also present if in case

any questions arise.

Due to prolonged sample collection, drawbacks may arise including

improper collection, improper mixing, spillage and improper measurement. This is

addressed by using a calibrated instrument which includes a graduated cylinder

for correct urine volume determination and a stirring rod for adequate mixing of the

specimens. Also, the entire collection is supervised by a trained health professional

to ensure near accurate results.

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CHAPTER II

REVIEW OF RELATED LITERATURE

Preeclampsia

Gestational hypertension is defined as blood pressure reaching 140/90 in

pregnant women after 20 weeks of gestation without the presence of proteinuria.

(Horsager, R., et al., 2014). Preeclampsia is defined as systolic blood pressure

(BP) level of 140mmHg or higher and diastolic BP of 90mmHg or higher, occurring

after 20 weeks of gestation. This is accompanied by proteinuria exceeding 300 mg

protein in 24-hour urine specimen, a urine protein: creatinine ratio 0.3; or

persistent 30 mg/dL (1+ dipstick) protein in random urine samples (ACOG, 2013).

In the absence of proteinuria, preeclampsia can still be present with the following

signs and symptoms accompanying the new onset of hypertension. This includes

thrombocytopenia with platelet count less than 100,000 /microliter, renal

insufficiency defined as serum creatinine concentration greater than 1.1 mg/mL or

a doubling of the serum creatinine concentration in the absence of other renal

diseases, impaired liver function with elevated transaminase, pulmonary edema

and cerebral or visual disturbances (ACOG, 2013).

8
Preeclampsia with severe features is defined as any of these features

present: an increase in blood pressure 160/110 mmHg on two occasions at least

four hours apart in a woman on bed rest, thrombocytopenia with platelet count less

than 100,000 /microliter, renal insufficiency defined as serum creatinine

concentration greater than 1.1 mg/mL or a doubling of the serum creatinine

concentration in the absence of other renal diseases, impaired liver function with

elevated transaminase, pulmonary edema and cerebral or visual disturbances

(ACOG, 2013).

Qualitative and Quantitative Evaluation of Proteinuria

Proteinuria is one of the cardinal features of preeclampsia (Somanathan,

N., Farrel, T., & Galimberti, A., 2003; Wagner, L. K.,2004). A recent

recommendation was to abandon the requirement that proteinuria be present to

confirm the diagnosis of pre-eclampsia, however, quantifying proteinuria is

necessary to confirm its diagnosis. Proteinuria is defined by the National High

Blood Pressure Education Program Working Group in 2001 as excretion of 300

mg or more of protein in a 24-hour specimen. This will usually correlate with a

concentration of 30 mg/dL (+1 on dipstick) in a random urine determination or

random spot urine protein/creatinine ratio of 30 mg/mmol and presumes that there

is no evidence of a urinary tract infection (Brown, M., et. Al., 2001). Although

proteinuria is central to the diagnosis and assessment of severity of preeclampsia,

9
the methods of recording its presence or extent are poorly described or

standardized.

The dipstick estimation of spot urine samples is the most commonly used

and recorded method. However, several studies showed that the accuracy of

dipstick urinalysis with a 1+ threshold in the prediction of significant proteinuria is

poor and therefore of limited usefulness to the clinician (Brown, M. A., & Buddie,

M. L.,1995; Rodriguez-Thompson, D., & Lieberman, E. S.,2001; Waugh, J. J., et

al., 2004).

An alternative method for quantitative evaluation of proteinuria is the

measurement of random urinary protein to creatinine ratio (UPCR), which avoids

the influence of variations in urinary solute concentration and provides a more

convenient and rapid method to assess protein excretion (Sanchez-Ramos, L.et

al,,2013) These are widely studied however with contradicting results. Several

studies had showed random UPCR as a valid correlation with 24-hour urine

collection (Price C.P., Newall, R.G, & Boyd JC, 2005; Wikstrom, A.K, 2006) and

some have evaluated the usefulness of the protein-to-creatinine ratio as a

screening tool for the evaluation of proteinuria in subjects with suspected

preeclampsia (Wongkitisophon, K. et. al, 2003; Justesen, T.I et. al, 2006).

Conversely, other studies have reported weaker correlation which showed that the

random protein/creatinine ratio did not reflect the protein/creatinine ratio from 24-

10
hour urine collection accurately, which suggested that the random protein/

creatinine ratio does not adjust adequately for variation in protein excretion from

hour-to-hour (Durnwald, C, & Mercer, B., 2003).

Many studies have been carried out to study the correlation of level of

proteinuria during different collection periods with that of 24 hour-urine protein. In

two different studies, total protein values for 8- and 12-hour urine samples correlate

positively with values for 24-hour samples for patients with proteinuria (Adelberg,

Miller, Doerzbacher, and Lambers, 2001; Rabiee, 2007).

Wongkitisophon, et. al. in 2003 and Amirabi and Danaii in 2011 both

showed that there was a correlation between 4-hour and 24-hour urine proteins.

The finding indicates that a random 4-hour sample might be used for the initial

assessment of proteinuria.

Two studies suggested that two-hour urine sampling offers the same clinical

information as 24-h urine collection for the evaluation of renal function in

pregnancy (Evans, et al., 2000; Somnathan, et al, 2003).

In a broader study conducted by Singhal, et. al, 2014, it was found out that

there was significant correlation (p value < 0.01) in two, four, eight and 12-hour

urine protein with 24-urine protein, with correlation coefficient of 0.97, 0.97, 0.96

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and 0.97, respectively. When a cut off value of 25 mg, 50 mg. 100 mg, and 150

mg for urine protein were used for 2-hour, 4-hours, 8-hour and 12-hour urine

collection, a sensitivity of 92.45%, 95.28%, 91.51%, and 96.23% and a specificity

of 68.42%, 94.74%, 84.21% and 84.21% were obtained, respectively.

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CHAPTER III

METHODOLOGY

A. RESEARCH DESIGN

A prospective analytical cross sectional study design was used for the

comparison of 12-hour urine albumin and 24-hour urine albumin in the diagnosis

of preeclampsia. Initial screening of patients admitted at the Obstetrics and

Gynecology Ward of Ospital ng Maynila Medical Center with features of

preeclampsia who met the inclusion criteria were identified and written consents

were obtained. During the 1st 48 hours of the patient, urine sample for the 12-hour

albumin and the 24-hour albumin were collected and sent to the reference

laboratory. Results were obtained and analyzed for the comparison of the 2

samples in the diagnosis of preeclampsia.

B. RESEARCH SITE

The study was conducted among pregnant women admitted at the

Obstetrics and Gynecology Ward of Ospital ng Maynila Medical Center (OMMC)

located at Barangay 719, President Quirino Avenue Corner Roxas Boulevard,

Malate, Manila 1004.

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C. OPERATIONAL DEFINITION OF VARIABLES

Independent Variable

12-hour Urine Albumin collection of urine sample to measure the amount of

protein in 12 hours

24-hour Urine Albumin collection of urine sample to measure the amount of

protein in 24 hours

Dependent Variable

Preeclampsia

hypertension (BP 140/90 mmHg) on two occasions at least four hours

apart after 20 weeks of gestation and/or hypertension (BP 160/110 mmHg)

on two occasions at least four hours apart in a woman on bed rest

proteinuria exceeding 300 mg protein in 24-hour urine specimen, a urine

protein: creatinine ratio 0.3; or persistent 30 mg/dL (1+ dipstick) protein in

random urine samples

In the absence of proteinuria, new onset hypertension with any of the following

signs and symptoms:

thrombocytopenia with platelet count less than 100,000 /microliter

renal insufficiency defined as serum creatinine concentration greater than

1.1 mg/mL or a doubling of the serum creatinine concentration in the

absence of other renal diseases

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impaired liver function with elevated transaminase

pulmonary edema

cerebral or visual disturbances

Confounders

Socio-demographic factors - includes the subjects age, educational status,

language and financial status

a. Age refers to the length of time the respondent has lived (years) at

the time of the study

b. Marital Status - status of an individual in relation to marriage,

classified as follows:

i) Single - A person who has never been married

ii) Married - A couple living together as husband and wife, legally or

consensually

iii) Common law cohabitating couple not legally bound

iv) Separated - A person separated legally or not from his/her

spouse because of marital discord or misunderstanding

c. Educational Attainment refers to the respondents highest attained

education.

d. Occupation refers to the respondents usual or principal work or

business, especially as a means of earning a living

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e. Financial Status refers to the self-reported monthly household

salary of the respondent. This was arbitrarily divided under the

following categories:

i. Low income those with monthly family income of Php 5,000

15,000

ii. Middle income - those with monthly family income of Php 15,

001-30,000

iii. High income - those with monthly family income of Php 30,001

and above

f. Religion - refers to the respondents set of beliefs, values, and

practices based on the teachings of a spiritual leader

D. SELECTION OF RESPONDENTS

Inclusion Criteria

Eligible respondents are those that are representative of the following criteria:

- Pregnant women admitted at the Obstetrics and Gynecology Department of

OMMC with elevated systolic and diastolic blood pressure of at least 140

and 90 mmHg respectively

- Patient length of hospital stay must be at least 24 hours

- Fourteen to forty-five years of age (14-45 y.o.)

- Minors (14-17 yrs. old) with accompanying legal guardian

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- Over 20 weeks age of gestation

- With clinical features of preeclampsia

- Length of stay within the area of study is less than 6 weeks

- Willing to participate in the study and duly signed patient consent

- Able to listen, speak, write and communicate in English or Filipino

Exclusion Criteria

- Those that refused to participate in the study

- Those with comorbidities or pre-existing medical condition such as pregnant

women with urinary tract infection, preexisting renal disease and chronic

hypertension

- Minors (14-17 yrs. old) without accompanying legal guardian

- Plan on giving birth in the province or outside Metro Manila

- Unable to listen, speak, write and communicate in English or Filipino

E. SAMPLING DESIGN

A letter approved by both the chief resident and the Chairman of the

Department of Obstetrics and Gynecology was sent to the Directors Office and

Chief of Clinics Center for approval before data collection. Identification of patients

admitted at the Obstetrics and Gynecology Ward of Ospital ng Maynila Medical

Center (OMMC) with features of preeclampsia and met the inclusion criteria for the

17
study were obtained. Eligible participants were given a brief overview of the study

and a consent form was asked to be filled out for those that agree to participate in

the study. All those that declined are considered non-responders. All participants

who are enrolled are asked to fill out the sociodemographic data and patients 12

and 24-hour urine albumin samples were collected with the guidance of health

personnel (nurse on duty, clinical clerk or post graduate intern).

The study was conducted on pregnant women consulting at Ospital ng

Maynila Medical Center on April 2017 to May 2017.

F. SAMPLE SIZE ESTIMATION

Sample size was computed using the Raosoft Sample Size Calculator.

Assumptions on confidence level, margin of error, population size and response

distribution were made based from the findings from previous literature on the

comparison of different hourly urine albumin collection in the diagnosis of

preeclampsia done by Crisologo and Flores in 2009. The computed sample size is

29 as shown in the figure below.

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G. DATA COLLECTION

Urine collection started at 8 am on the first morning after admission to the

hospital. Prior to urine collection, all women were carefully instructed regarding the

procedure. Ice boxes were provided for storage of the urine specimen throughout

the 24-hour urine collection. The samples were collected using a Foley catheter to

ensure standardization of urine collection. At 8 am patients urine bag was drained

which signals the start of the collection period. The urine samples for each patient

were collected in two separate and clearly marked containers. One of the

containers was used to collect the first 12-hour urine sample (from 8 am to 8 pm)

and labelled Bottle #1, and the other one was used for the subsequent 12-hour

urine sample collected from 8 pm to 8 am the following day which was labelled

Bottle #2. After the 24-hour specimen collection, the sample in each bottle was

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thoroughly mixed using a stirring rod to ensure sample homogeneity. The urine

volume of Bottle #1 was obtained using a graduated cylinder which was then

recorded. A 5-mL aliquot was collected and placed in a clean vial. This represents

the 12-hour sample. Bottle # 1 was then mixed to Bottle #2 with thorough mixing.

Total volume was determined and another 5-mL aliquot was obtained which

represented the 24-hour urine collection. Both samples are sent to the reference

laboratory for sample processing. Results are obtained after 2 working days.

Urine concentration of protein in the two samples were determined using dipstick

method. The total urinary protein (mg/day) was determined by multiplying the total

urine volume (dl) by the concentration of protein in the test sample (mg/dl).

H. DATA QUALITY CONTROL, PROCESSING AND ANALYSIS

The 24-hour urine protein was used as a gold standard to determine the sensitivity,

specificity, positive predictive value (PPV) and negative predictive value (NPV) of

12-hour urine sample. The receiver operating characteristic (ROC) curve was used

to determine the cut-off point for predicting proteinuria. Demographic data are

presented as descriptive graph and the variable age as meanSD. The results of

the 12-hour urine samples were compared to the 24-hour urine results by simple

regression analysis to determine a correlation coefficient (r) by using Statistical

Package for Social Sciences (SPSS, version 24). A p-value of < 0.05 was

considered statistically significant.

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RESULTS

A total of 20 patients were eligible and thus included in the study. The

findings indicate that the mean age of the study population is 31.9 7.22 years.

Figure 1 represents the percentage distribution of Marital Status of the

respondents. Majority of the respondents 9 (45%) have common law partners. Six

(30%) were married, 3 (15%) were single and 2 (10%) were common law.

Figure 2 represented patients educational attainment. Eleven (55%)

reached college level, 5 (25%) were college graduates, 3 (15%) reached high

school level, 1 (5%) was able to reach elementary level.

Figure 3 represents the frequency distribution based on occupation. Twelve

(60%) of patients were employed, 2 (10%) were self-employed and 6(30%) were

unemployed. On the other hand, figure 4 below represented the distribution of

respondents based on financial status. Eight (40%) of the parturients answered

that they belong to the middle-class income earners. Eight (35%) came from a

high-income class household and 5 (25%) came from low-income class household.

Lastly, figure 5 denoted the percent distribution of patients based on

religion. Majority of patients 16 (75%) were Catholics, 4 (20%) were Born Again

Christians and 1 (5%) belonged to the Jehovahs Witness sect.

As shown in Table 2, we found meaningful correlations between 12 hour-

urinary protein concentrations and traditional 24-hour urine albumin values. PPV,

21
NPV, sensitivity and specificity for the gold standard 24-hour urine protein

collections were respectively all 100% The same indices for the 12-hour urine

protein collections were 100%, 92.9%%, 85.7% and 100% Accuracy for 12-hour

urine protein determination was 95.0%

The area ROCof both 24 hour urine and 12 hour urine samples are shown

in Figures 6 and 7 respectively. The area ROC curve as shown in Figure 7,

identified that a value of 176.240 mg/d in the 12-hour urine sample has the highest

prediction value, (in comparison

The analyzed data revealed that 12-hour urine samples could be used to

measure proteinuria in women with preeclampsia, but 24- hour urine protein still

remains the gold standard test for diagnosis of significant proteinuria.

DISCUSSION

The socio-demographic variables showed that the standard age of patients

was 31.9 7.22 years. Most patients were Catholics (75%) and reached college

level (55%). Multiple studies suggest that the risk of preeclampsia is higher for very

young pregnant women as well as pregnant women older than 40. (Skjaeryen,

Wilcox and Lie, 2002; Catoy, Ness, Kip and Olsen, 2007). In the study, majority of

the pregnant patients were employed. Studies suggest that being employed

outside the home is a risk factor for development of preeclampsia as compared

22
with a housewife. The working status of women increases the risk due to increased

stress levels brought by work. (Ross, et. al, 1998).

Preeclampsia is a serious complication of pregnancy resulting in maternal

and perinatal morbidity and mortality. Proteinuria establishes the diagnosis of

preeclampsia and is a reliable factor in the prognosis of the disease. Currently the

24-hour urine is the gold standard for the evaluation of proteinuria. There are

multiple laboratory tests used in the detection of proteinuria. The most commonly

used is the dipstick method for random urine specimens however it has been

proven to have low sensitivity and specificity (Price, Newall and Boyd, 2005).

Currently, the gold standard is still the 24-hour urine albumin determination

however, it was found to be time consuming and inconvenient for both the patient

and the health staff handing the urine collection.

A shorter period of diagnosis is therefore needed in order to provide clinical

benefits such as prompt diagnosis and early administration of treatment leading to

earlier hospital discharge rates and lower health care costs. Patient compliance

will improve since urine collection is shortened and simplified (Schubert and

Abernathy, 2006).

Many studies have been carried out to study the correlation of level of

proteinuria during different collection periods with that of 24 hour-urine protein. In

a study using protein to creatinine ratio, it showed significant correlation with the

standard 24-hour urine albumin However, this only holds true for patients with

23
protein values of less than one gram in 24-hours. (Aggarwal, et. al, 2008).

However, there is also a study revealing that the random urine protein to creatinine

ratio was not a good predictor of significant proteinuria in patients with

preeclampsia (Papanna, et. al, 2008).

Several studies have been done for the evaluation of proteinuria in a shorter

period (2, 4, 6, 8 and 12 hours). A large-scale study revealed that there was

significant correlation (p value < 0.01) in two, four, eight and 12-hour urine protein

with 24-urine protein, with correlation coefficient of 0.97, 0.97, 0.96 and 0.97,

respectively. Furthermore, when a cut off value of 25 mg, 50 mg. 100 mg, and 150

mg for urine protein were used for 2-hour, 4-hours, 8-hour and 12-hour urine

collection, a sensitivity of 92.45%, 95.28%, 91.51%, and 96.23% and a specificity

of 68.42%, 94.74%, 84.21% and 84.21% were obtained, respectively (Singhal, et.

al, 2013). A study done by Adelberg et. al, in 2001, concluded that total protein

values for 8- and 12-hour urine samples correlate positively with values for 24-hour

samples for patients with proteinuria.

A study revealed significant correlation between the 2-hour and 24-hour

urine protein levels (Pearson's correlation coefficient 0.76 (P 0.000) hence

concluded that a random 2-hour sample could be used for the initial assessment

of proteinuria and so avoid the delay associated with 24-hour quantification of

urinary protein (Somanathan, Farrell and Galimberti, 2004)

24
In a study by Amirabi and Danaii in 2011, there was noted significant

correlation between 4 hour samples and 24 hour samples (P<0.001, r=0.86).

Congruent results were also presented by Wongkitisophon, et al. in 2003 regarding

4- hour urine protein value and the standard 24-hour urine protein.

Rinehart et al. in 1999 studied the correlation of two consecutive 12-hour

urine samples with that of a 24-hour urine collection in 29 patients of preeclampsia

and showed sensitivity of 96%, specificity of 100%, positive predictive value of

100%, negative predictive value of 80%, and a correlation coefficient of 0.89. In a

similar setting, Kieler et al. in 2003 compared 12-hour urine samples with 24-hour

urine collection in 30 women with preeclampsia. It was found that 12-hour

collection correlated well with 24-hour collection and they concluded that 24-hour

urine collection can be substituted with 12-hour collection. This study also yielded

similar results. It was found out that the positive predictive value, negative

predictive value, sensitivity and specificity of the 12-hour urine albumin were 100%,

92.9%%, 85.7% and 100% respectively. The 12-hour urine albumin was

significantly correlated to the 24-hour urine albumin (P<0.0001; r=0.956).

CONCLUSION AND RECOMMENDATION

The findings of this study indicate that the 12-hour values of urine protein

correlated positively with values of 24-hour samples. This might be used as

evidence to suggest the values of total urine protein of 12-hour samples might be

25
used for initial assessment of preeclampsia. The use of such samples for the

assessment of preeclampsia helps avoid the patients' inconvenience and delay in

the treatment of the disease.

A bigger sample size is recommended for future researches as to increase

the power and significance of the study.

26
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32
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Chem 2005; 51: 1577-86.

33
APPENDIX

Figure 1. Percent Distribution by Marital Status of


Respondents

10% 15%

Single
Married
Common law
30%
45% Separated

Figure 2. Percent Distribution by Educational Attainment


of Respondents

5%

25% 15% Elementary


Level
High School
Level
College Level

College
Graduate

55%

34
Figure 3. Percent Distribution by Occupation of
Respondents

10%

30% Unemployed

Employed

Self-employed

60%

Figure 4. Percent Distribution by Financial Status of


Respondents

25%
35% Low income

Middle income

High income
40%

35
1

0.9

True positive rate (Sensitivity)


0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0
0 0.2 0.4 0.6 0.8 1
False positive rate (1 - Specificity)

Figure 6. The receiver operating characteristic (ROC)

curve of 24-hour urine samples.

0.9
True positive rate (Sensitivity)

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0
0 0.2 0.4 0.6 0.8 1
False positive rate (1 - Specificity)

Figure 7. The receiver operating characteristic (ROC)

curve of 12-hour urine samples..

36
1

0.9

0.8
True positive rate (Sensitivity)

0.7

0.6

0.5
12 hour urine albumin
0.4 24 hour urine albumin

0.3

0.2

0.1

0
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
False negative rate (1 - Specificity)

Figure 8. Correlation between the 12-hour urine protein and 24-hour urine

protein

37
Table 1. List of all Respondents with 12-Hour Urine Albumin and 24-hour Urine

Albumin Determination

ID Age 12-hour Urine 24-hour Urine

Albumin Albumin

1 24 112.6 107.1

2 38 141.7 200.7

3 34 55.1 198.4

4 39 117.3 169.3

5 35 95.0 132.0

6 21 50.0 67.0

7 36 186.0 152.0

8 19 91.0 83.4

9 26 82.0 60.0

10 43 111.0 118.0

11 31 141.0 194.0

12 33 176.24 244.0

13 39 98.0 145.0

14 39 148.0 142.0

15 24 906.0 1346.0

16 42 26.0 80.0

17 35 365.0 210.0

38
18 25 451.0 487.9

19 26 637.0 671.0

20 29 755.0 799.5

Table 2. Correlation Parameters Between 12-Hour Urine Albumin and 24-hour

Urine Albumin

12-hour Urine Albumin 24-hour Urine Albumin

Sensitivity 85.7% 100.00%

Specificity 100.00% 100.00%

Positive Predictive 100.00% 100.00%

Value (PPV)

Negative Predictor 92.9% 100.00%

Value (NPV)

Accuracy 95.0% 100.00%

Cut-off Point for 176.240 300.00

Proteinuria

r 0.956 1.0

P value <0.0001 <0.0001

39
A Comparison of 12- and 24-Hour Urine Albumin Levels in the Confirmation
of Diagnosis of Preeclampsia Among Hypertensive Pregnant Patients
Consulting at a Tertiary Hospital in Manila from April May 2017
Principal investigator: Arlene P. Umali M.D.

Participant Consent Form


Magandang araw!
Ikaw ay napili upang makilahok sa isang pag-aaral sa ospital na ito, na naglalayon
na alamin kung ang lebel ng albumin sa ihi sa loob ng labindalawang (12) oras ay
maihahambing sa lebel ng albumin sa ihi sa loob ng dalawamput apat (24). Ang
mga nasabing test ay ginagamit upang masabi kung may Preeclampsia ang isang
buntis. Ang magiging resulta ng pag-aaral na ito ay magagamit upang matukoy
ang mga bagay na may kinalaman sa preeclampsia at kung paano mas
maaalagaan ang mga pasyenteng buntis na meron nito.
Maaari rin itong makatulong na maging basehan sa pagbuo ng mga polisiya na
makakatulong upang makamit ang layunin ng Millenium Development Goal na
pagandahin ang kalusugan ng mga ina at ang layunin ng Sustainable
Development Goal na magkaroon ng magandang kalusugan ang lahat ng mga
tao.

Kung kayo man ay pumapayag na sumali sa pag-aaral na ito, mayroon lamang


kaming papasagutan na questionnaire pagkatapos ng inyong admission dito sa
Ospital ng Maynila. Pagkatapos niyo manganak, ipapagawa po natin ang test na
tinatawag na 12-hour urine albumin at 24-hour urine albumin. Maglalagay sa
inyo ng sonda o catheter upang direktang makolekta ang inyong ihi. Matapos
ang labindalawang oras, kukuha ng kaunting sample mula sa nakolektang ihi at
ipapadala ito sa laboratoryo upang maproseso. Matapos nito ay patuloy pa rin ang
pagkolekta ng ihi sa susunod na labindalawa pang oras. Matapos ang
dalawamput apat na oras, ipapaproseso ang lahat ng mga makokolektang ihi at
tatanggalin na ang inyong sonda o catheter niyo. Mayroong propesyunal na
magpapaliwanag sa inyo kung ano ang mga dapat gawin bago simulan ang
pagkolekta ng inyong ihi. Matapos ang takdang oras ng pagkolekta ng ihi,
ipapaliwanag sa inyo ng inyong doktor ang naging resulta ng mga nasabing test.
Wala kayong kakailanganin na bayaran para sa mga ipapagawang test sa pag-
aaral na ito.

Kung mayroon mang parte ng pag-aaral na ito na nalilito o may problema kayo,
maaari niyong kausapin ang pangunahing nagsasagawa ng pag-aaral. Wala man
kayong direktang benepisyo na makukuha sa pagsali niyo sa pag-aaral na ito,

40
makakatulong ang mga impormasyon na maibabahagi niyo upang mas malaman
kung makakatulong ang lebel ng ihi sa loob ng labindalawang (12) oras sa
pagkumpirma kung may Preeclampsia ang isang buntis. Bukod dito,
makakatulong rin kayo upang makagawa ng mga programa na mas
makakapagpaganda sa estado ng kalusugan ng mga nagbubuntis. Dahil dito,
lubos naming inaasam na kayo ay makakalahok sa pag-aaral na ito.

Deklarasyon
Nabasa at naintindihan ko ang mga nakasaad sa information sheet at ang layunin
ng pag-aaral na ito. Naiintindihan ko na:
Kung ako ay lalahok sa pag-aaral na ito, ito ay dahil personal ko itong
kagustuhan.
Ako ay pumapayag na sumailalim sa mga tests na kasama sa pag-aaral na
ito.
Maaari akong tumanggi na sagutin ang kahit anong katanungan kung ito
ang nais ko.
Naiintindihan ko na ang mga sagot ko sa questionnaire at ang resulta ng
mga ipapagawa sa aking tests ay mananatiling pribadong impormasyon.

Consent

Ako ay pumapayag / hindi pumapayag na makilahok sa pag-aaral na ito. (Bilugan


ang inyong kasagutan)

Lagda: ___________________

Petsa: ____/____/____

41