COILEGE OF PHYSICIANS & SURGEONS PAKISTAN

REGIONAL CENTRE
Rovi Rood, PIMS, G-8/3,ISLAMABAD

Ref. no. F-1.4-1/CPSP-ID/SAC/25/

Dated 27th F ebruary, 2025
Synopsis #10754
Dr.Aqsa Iram
oBG-2023-277-12391
3067123434

Dear Doctor,

Please refer to your synopsis titled:

"Association of oligohydramnios and intrauterine growth restriction (IUGR) with working

women I A correlational study"

Your slmopsis has been examined by the Synopsis Assessment Committee and some
observations/suggestions have been made (Copy enclosed).

Please Note:

Followine Documents Are Required For ssion of S.moosis after Re-Upload on E-Portal

1. Two corrected copies of Synopsis (single-sided print)

2. Two covering letters (duly signed and stamped by supervisor),
3. Non-duplication Certificate (duly signed and stamped by supervisor)
4. Ethical Committee letter (Photocopy)
5. One incorrect copy (Revised Synopsis)
6. A copy of RTMC
7. A copy of screenshot of Re-uploaded synopsis on E portal

Thanking you,

Yours Sincerely

I^

Dr. Tayya aisal

Senior Consultant Epidemiologist,
Regional Centre,
CPSP Islamabad

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ii r' 4(r : OIIG-2023-277 -1239 SPIICIALITY: OBG & GYN
l'", .lvtE: Dl.Aqsa Iram D/o.W/o : Saiid Faroocl
S/o.
. .,e ol Comnrencement o1'l'raining: 09.01.2023 RECEIVED :26.12.24
l:('i-,S-[ ROI-t, No # 7301u SESSION :2023
INSTI'|UTIONS: Aziz Iiatirnnh I Iospital/ ."'.' :-.
:l L i P i-r itvl S I OR: Dr'. Rahi I a Fathat Clharudhr)'
F-atima N4edical & Dental Colle I.-SD

i., l,rl-, No: 3067 1 23434 Email : 4960airnht@grnai l.com

TIT
cirrtio amnio$ and intrauterine growth restriction (IUGR) with working
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TO WHOMIT MAY COI{ CERN

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Itisto certlfythatthc synopslstoplcof Dr. AQ$A InM

,,Assoclatlon of Ollgohydramulos and tntrauterke Growth Restdctlon

{IUGR) with Worklng Women;
A Correlatloual etudy"

ls original and it has not been duplicated ln A:iz Fatimah or other

training hospital of this city during last 5 years.

ox.
&
ttanttl

Dr. Rahila Farhat Chaudhry

Professor of Obstetrics and
Aziz Fatimah Hospital
Faisalabad.

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S twtikttiww(,

Oute: 15,1017Q24

Rpf. Nq; IE#*a3.?4 :

Receareh ?itle: AssCIciaiio* *f Ofig$hidrunrfiie$ and trttragtsrine Orowth Restricliou

Workingwomen: A'Conclarioaal *tirdy. :

a.

Ilrinripal Inv*rtigator(s): Dr: Aqca lrm '.:

you ars hcreby inlormed that your aforcmcntioned research proposal is approved by ctlricol

gne year to conduct this

committee. after rcview and discussion. This approval is for a period of

study.

'
Prof. Dr. Ghulam Abbas Sheikh AtO
i
ChtirmanlnstitutionllEtlricaltommittee
1,,
tf

This e thical approval is irsued subjce r to thc folluwing conrlitiuns:

L A signed personal deelaration of rcsponsibility'

Z. If the rcsearch question changes sigrri{icantty so as to alter the nature of thc utudy' a new
, uz
applicction for cthical clcarance tttust bc subrrtittcd.
j. Ir renrains rhe Principal investigator's responsibility to ensure that allthe necessary forms
and informed consent are retained for further rclbrence'

tPlease quote IEC approval number in all inquiries

Cc: Departmenl of Mcdical Education

a--...--

S CamScanner
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The Director
Research, Training and Monitoring Cell
College of Physician and Surgeon, Pakistan,

Researc ,h Tooic

,,Association of Oligohydramnios and Intrauterine Growth Restriction

(IUGR)withworkingwomen;ACorrelationalstudy,,

Submitted bY Superuised bY

Dr Aqsa Irm Prof.Dr Raheela Farhat Ch.

RTMC No: OBG -2023-277 -1239 I

PROF. DR. FARIIAT CT}

MB85, (6old Medalt$)
l
f,L Medlcal &
t- Signature: Signa

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d-

T1\
.l

The Director
Research, Training and Monitoring Celi
College of Physician and Surgeon, Pakistan,

Research Topic

,,Association of Oligohydramnios and Intrauterine Growth Restriction

(IUGR)withworkingwomen;ACorrelationalstudy,,

Submitted bY Supenrised bY

Dr Aqsa Irm Prof.Dr Raheela Farhat Ch'

RTMC No: OBG -2023-277 - L239 I

F
t' 6 PROF. DR. TABHAT CE.
(6old Medall$i
MBBS,
Profe9sor
Fatl Medlcal &
Signature: Signa

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r 1

Association of Oligohydramnios and Intrauterine Growth Restriction

(IUGR) with working women I A Correlational study
Introduction
The amniotic fluid surrounding the fetus is a vital component for
intrauterine fetal growth and development. It helps in regulating
temperature, promotes lung development, provides space for
musculoskeletal development, averts umbilical cord compression, and helps
in escaping injury and effects of uterine contractions. Therefore, it is an
important indicator of fetal well-being and is an important assessment
parameter in the surveillance of fetal developmentl.

Oligohydramnios is defined as a condition with a low volume of amniotic

fluid relative to gestational age. The condition affects 3- 5o/o of the
pregnancies2. Usually, the degree of Oligohydramnios is proportional to the
severity of placental hypoperfusion and IUGR (Intra Uterine Grt-rwth
Restriction)s. IUCR is a condition where fetus fails to achieve its genetic
i
?.
potential, leading to perinatal morbidity and mortality. It is commonly
associated with oligohydramnios as uteroplacental insufficiency common in
both. Increased perinatal morbidity and mortality could be because of the
umbilical cord compression, potential uteroplacental insufficiency and
increased incidence of meconium-stained amniotic fluid and
oligohydramnios. However, some of the recent studies have shown no effect
of isolated oligohydramnios in perinatal outcome. Decrease of amniotic fluid
volume and IUGR is associated with increased labour induction, stillbirth,
non-reassuring fetal heart pattern, meconium aspiration syndrome and
neonatal death. The most likely cause of oligohydramnios in IUGR babies is
decreased urine outputa. Chauhan et al conducted a study to determine the
e n &rrd oligohydramnios
r-* f uJ B't \e'.r+-"t , rniQ rr'4"rrf-* a1919"
r high-risk patients. Among* total 18 etons, IUGR was suspected in
k ))
! ry
22oh and the prevalence of oligohydramnios was 60/07.
-:*:::-

Oligohydramnios and Intrauterine are the

conditions that complicates the pre ted local data is
these condtions aro, this study is carried out to assess e for

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development of IU in working women study will help to develop
guidelines for women with these conditions to reduce feto-maternal
morbidity and mortality.

OBJECTIVE
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To dete SSO of Oligohydramnios and ^lntrauterine Growth
Restriction (lU in working women

OPERATIONAL DEFINITIONS
a
Working Women: A female person engaged d employment or labor.

Oligohydramnios: assessed on ultra-sonographic examination as Amniotic

Fluid Index (AFI) less than 5 cm or largest pocket in broadest dimension is
less than 2 crn will be labelled as oligohydramnios.

Intrauterine Growth Restriction: will be defined as birth weight below the

1Oth percentile for gestational age and appropriate weight for gestational age
(AGA) as birth weight between 1Oth and 90th percentile.

METHODS
Study
LW flq 16u';ttfn, r,;ffi
S

Setting: Department of Gynecologlr, Aziz Fatima Hospital Faisalabad )L

v {o{5,:.t,}.^

Duration: 6 months after the approval of synopsis

Sample Size: It is obtained usi_4g WHO sample size calculator at

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Level of
t'*e'm
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Absolute precision= 3o/o
cr.nF1 *]: %;' io, *#"*3
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Sample Size calculated:24 t *^uf
 Sampling Technique:
Non probability Consecutive sampling

pen dant Variables:

. Oligohydramnios
.
Intrauterine Growth GR)

Indepe ndant Variables:

. Working Sta
Inclusion Criteria:
' Age 18-40 Years

. Gestational age 28:40 weeks

a Singleton pregnancy

a Undergoing biophYsical Profile

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76

Exclusion Criteria:

i: o Multiple pregnancy

a Pregnancies complicated with medical illness like gestational diabetes,

preeclampsia, Severe anemia, liver disorders and heart diseases

o PPROM (Preterm branes

Q
othesis: There is no asso ciation between oligo and
N
f.:) r-.
intrauterine growth restriction (IUGR) with working women ()
I
Alternate Hypothesis: There is an association between oligoh
and intrauterine growth restriction (IUGR) with working women

DATA

After the approval from hospital ethical review committee patients will be
enrolled after matching inclusion and exclusion criteria. Written informed
consent will be taken from patients. Patients fulfilling the inclusion criteria
will be included in study. Demographic and Clinical features of patients will
be noted such age, parity, BMl, gestational age' A11 required investigation
,
ri'ill be done. A11 women wili undergo biophysical profile. Oligohydramnios
s.ill be confirmed by measuring AFI as per definition.
Intrauterine Res as birth weight ,e

lOth percentile age an appropriate t for gestational age

(AGA) as birth weight between 10ft and 90th percentile. A11 the da will be
collected on pre-designedquestionnaire.

DATA ANALYSIS

The data will be"'analyzed in SPSS version 25.O. Frequency

percentages will be calculated for gravidity, P.li!y, Mis
(,' PE*m'l
/c,
socioeconomic status, resicience, Type of em
Oligohydramnios, IUG t
SD will be calculated for age, gestational
f,4dPi
age, weight, height, BMI, AFI, Fetal weight. Chi-square test will be applied.
The stratification will be done for age, gestational age, BMI, parity, gravidity
socioeconomic status and to see the effect on Oligohydramnios, IUGR. Post
stratification chi-square test will be applied and the p- value <0.05 will be
considered as statistically significant.
L{ &, fut/ d,(, 't( IN
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\ ,.Association of Oligohydramnios and Intrauterine Growth Restriction

(IUGRI in working womenl A Correlational study "

Name: - Ase: Years Gestatioqal ase

weeks

Residence: - Rural/Urban

Socioeconomic Status: - Lower/Midde/High

Weight: - kg Height: ' cm BMI:- kglrr,2

Gravidity: -

Parity: -

,
Misscarriages: -
rt I V
G
i'. dt'
Type of Employment or Labor z ?

(-) lrclY \l *\
Qualification: '7

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l- G{ f'/1.
,(:

Main outcome Variable: - I [l J' Si

(
kl \ \Ad
I
Oligohydramnios: Yes/ No

a,/-
Diagnosis By: Clinical examination/Ultrasound

If Ultrasound then Ultrasound done by:

Radiologist/ Obstetrician / WM O / Midwife

a

Amniotic Fluid Index (AFI| : cm

Maximum Vertical Pool (MVPI: cm

History of PPROM: Yes/No

t
\

IUGR: - Yes/No

Estimhted Fetal Weight (EF.W): Kgs

Weight of baby at the time of Birth: Kgs

Associated Medical Conditions if any:

la
:

a
aF

f
References:

l. Figueroa L, McClure EM, Swanson J, Nathan R, Garces AL, Moore JL,

et al. Oiigohydramnios: a prospective study of fetal, neonatal and
maternal orltcomes in low-middle income countries. Reprod Health.
2o2o;77(t\:7-7.

L. Iqbal I, Asghar S, Nisa K, Rashid F, Qureshi KK, Riaz R. Case*Control

,--'
Study on Fetal Outcomes in Isolated Oligohydramnios in Third
Trimester. J Rawalpindi Med ColI. ZCjZZ;26(l|: 57-61.

b a Talesara H, Shah VC, Modi DA, Modi RS. Fetomaternal outcome in

pregnancy with oligohydramnios: a prospective study Int J Reprod
Contracept Obstet Gyneco1.202 1; 10:57 l-4.

{.,1
I
l Singia R. Assessment of Risk factors and Fetal Outcome in Pregnant
Women with Intra Uterine Growth Retardation. Euro J Pharm Med
I

Res. 20 19;5(7): 302-05.

I
\. He Y, ZinengD, Shang W, Wang X, Zhao S, Wei Z, et al. Prevalence of
oligomenorrhea among women of childbearing age in China: a large
ta- community-based studY. Women's Health. 2O2O; 16:
//
e 1745506520928617 ,

A a Brzezinski-Sinai NA, Stavsky M, Rafaeli-Yehudai T, Yitshak- Sade M,

p,rzezinski-Sinai I, Imterat M, et al' Induction of labor in cases of late
preterm isolated oligohydramnios: is it justified?. J Matern Neonatal
,.
Med. ):2271-9

1y Chauhan SP, Taylor M, Shields D, Parker D, Scardo JA, Magann EF

r high*risk
intrauterine growth restriction and. oligohydramnios among
patients. Amer J Perinat ot. Z,A6||?4 ^tO4) :2 I 5 -2 1 .
':;r*'=:.-.*'r {-.--{/

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Dcar Sir,

"Agsoclatlon of
Enclosed hercwith please find thc rescuch protocol titled:
(IUGRI wlth
oligohydramrlos snd latteuterlne Growth Reatrlctlon
WorktnS! Womeu; A Correlationat atudyn

As a prc-requisite of FCPS-lt in rhc subject of obstetrics and Gynecology

Pren:rrcd br':

;. RTNC Reskttptiort:
'i tu,
Srrbrnilled on:

\:rrnr of Suncn'isor: Prof . Dr Rahila Farhat ChaudhrY

i
ta
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Designrtionl

Name

/. Signature:

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Atlr f.tltha M?dls.t &
grntet Coil*f{ ttlrrl'bld

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