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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
SYNOPSIS
OF
DISSERTATION
"PERINATAL OUTCOME IN CASES OF AMNIOTIC FLUID INDEX
< 8 CENTIMETERS"
Submitted by
Dr. SOWMYA. K.N.
M.B.B.S.
POST GRADUATE STUDENT IN
OBSTETRICS AND GYNAECOLOGY (M.S)
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,
B.G.NAGARA-571448
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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
Dr. SOWMYA. K.N.
P.G IN OBSTETRICS AND GYNAECOLOGY,
ADICHUNCHUNAGIRI INSTITUTE OF
MEDICAL SCIENCES.B.G NAGARA,
MANDYA DISTRICT -571448
1
NAME OF THE CANDIDATE
AND ADDRESS
(in block letters)
2.
NAME OF THE INSTITUTION
3.
COURSE OF STUDY AND SUBJECT
M.S. IN OBSTETRICS & GYNAECOLOGY
4.
DATE OF ADMISSION TO COURSE
02-06-2008
5.
TITLE OF THE TOPIC
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.
“PERINATAL OUTCOME IN CASES OF
AMNIOTIC FLUID INDEX < 8
CENTIMETERS”
BRIEF RESUME OF INTENDED WORK
6.
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6.1 NEED FOR THE STUDY
APPENDIX-IA
6.2 REVIEW OF LITERATURE
APPENDIX-IB
6.3 OBJECTIVES OF THE STUDY
APPENDIX-IC
MATARIALS AND METHODS
APPENDIX-II
7.1 SOURCE OF DATA
APPENDIX-IIA
7.2 METHOD OF COLLECTION OF
DATA : (INCLUDING SAMPLING
PROCEDURE IF ANY)
APPENDIX-IIB
7.3 DOES THE STUDY REQUIRE ANY
INVESTIGATION OR INTERVENTIONS
TO BE CONDUCTED ON PATIENTS OR
OTHER ANIMALS, IF SO PLEASE
DESCRIBE BRIEFLY.
7.4 HAS ETHICAL CLEARENCE BEEN
OBTAINED FROM YOUR
INSTITUTION IN CASE OF 7.3
8.
APPENDIX-I
LIST OF REFERENCES
YES
APPENDIX-IIC
YES
APPENDIX - III
2
9.
SIGNATURE OF THE CANDIDATE
10.
REMARKS OF THE GUIDE
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NAME AND DESIGNATION
(in Block Letters)
11.1 GUIDE
Prof. Dr. S. VIJAYALAKSHMI, M.D , D.G.O
Professor and Head
Department of Obstetrics and Gynecology
AIMS, B.G. Nagara-571448
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY)
Prof. Dr. BALAKRISHNA. B.V.,
Professor and Head
Department of Radiodiagnosis,
AIMS, B.G. Nagara-571448
11.4 SIGNATURE
Prof. Dr. S. VIJAYALAKSHMI, M.D , D.G.O
Professor and Head
Department of Obstetrics and Gynecology
AIMS, B.G. Nagara-571448
11.5 HEAD OF DEPARTMENT
11.6 SIGNATURE
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12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL
12.2 SIGNATURE
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APPENDIX-I
6.BRIEF RESUME OF THE INTENDED WORK:
APPENDIX –I A
6.1 NEED FOR THE STUDY:
This study is done to know the perinatal outcome in cases of amniotic fluid index < 8 cm
at term. Oligohydramnios is associated with increased incidence of adverse perinatal outcome,
and hence this study is done to establish the need.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
1. Williams text book of Obstetrics, 22nd edition, F.Gary Cunningham, Kenneth. J. Leveno.
The amnion at term is a tough and tenacious but pliable membrane. It is the innermost
fetal membrane and is contiguous with amniotic fluid. The amnion is the tissue that provides
almost all the tensile strength of the fetal membranes.
The human amnion is first identifiable about the 7th-8th day of embryo development.
Initially a minute vesicle, the amnion develops into a small sac that covers the dorsal surface of
embryo. As amnion enlarges it gradually engulfs the growing embryo, which prolapses into its
cavity.
In early pregnancy amniotic fluid is an ultrafiltrate of maternal plasma. By the beginning
of the second trimester, it consists largely of extracellular fluid that diffuse through the fetal skin
and thus reflects the composition of fetal plasma. (Gilbert and Brace, 1993).
After 20 weeks, the cornification of fetal skin presents this diffusion and amniotic fluid is
composed largely of fetal urine.
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The fetal kidneys start producing urine at 12 weeks and by 18 weeks they are producing
7-14 ml of urine per day.
Fetal urine contains more urea, creatinine and uric acid than fetal plasma. It also contains
desquamated fetal cells, vernix, lanugo and various secretions. Because these are hypotonic, the
net effect is decreasing amniotic fluid osmolality with advancing gestation.
Pulmonary fluid contributes to a small proportion of amniotic fluid volume and fluid
filtering through the plasma accounts for the rest.
Clearance :
Is mainly through the fetal swallowing of the amniotic fluid and intra membraneous
absorption. Swallowing begins at 10-12 weeks, coincident with the ability of the small intestine
to undergo peristalisis and transport glucose actively.
Fetal swallowing appears to have little effect on amniotic fluid volume in early pregnancy
because volume swallowed is small. However late in pregnancy, the volume of amniotic fluid
appears to be regulated substantially by fetal swallowing, for when swallowing is inhibited,
hydramnios is common.
Term fetuses swallow between 200-760 ml per day.
2. Brace R.A. Pitkin Roy M., Scot James R., Phriladelphia “Amniotic fluide regulators in
clinical obstetrics and gynecol” – Raven Publication 1997, 40 (2) : 280-9.
Goodlin et al., have shown that, there is strong correlations between maternal plasma
volume and amniotic fluid, i.e., elevated maternal plasma volume is associated with
polyhydramnios and decreased plasma volume with oligohydramnios.
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3. Arias Fernando Practical guide to high risk pregnancy and delivery, 2nd edition, MosbyYear book Inc 1993 : 3-20, 150-159.
Amniotic fluid volume increases rapidly in first half of pregnancy, it is about 60 ml at the
end of 1st trimester, 100-150 ml at 16 weeks, 700 ml at 32 weeks, 800-1000 ml at 37 weeks,
decreases thereafter 700-800 ml at 40 weeks, 400-450 ml at the end of 42 weeks, 250 ml at 43
weeks and 160 ml at 44 weeks of gestation.
4. Ian Donald’s practical obstetric problems – Renu Misra , 6th edition.
Manning et al., defined oligohydramnios when largest pocket on USG in its broadest
diameter measured less than 1 cm. Subsequently they revised this criteria to single pocket
measuring 2 cm in both vertical and horizontal planes.
Phelan described amniotic fluid index and oligohydramnios was defined as amniotic fluid
index < 5 cm and borderline oligohydramnios as AFI between 5-8 cm and polyhydramnios as >
20 cm.
Causes :
1. Maternal
: Postdatism, hypertension, premature rupture of membranes,
autoimmune disorders.
2. Fetal
: Intra uterine growth restriction, fetal anomalies i.e., renal
anomalies.
Effect of Oligohydramnios :
Increased intervention in the form of induction of labour and caesarean delivery may
increase maternal morbidity. Increased perinatal morbidity and mortality has been reported in
pregnancies with decreased amniotic fluid volume, particularly when it occurs remote from term.
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Incidence of small for gestational age babies, meconium aspiration, fetal heart rate
decelerations, abnormal position of hands and feet, potterfacies, pulmonary hypoplasia, low
apgar score, NICU admission, fetal distress are found to be higher in cases of oligohydramnios.
5. Newbould MJ, Lendon M, Barron AJ : “Oligohydramnios sequence ; Spectrum of renal
malformation” Br. Journal Obstet Gynecol 101 : 598, 1994.
Described autopsy findings in 89 infants with oligohydramnios sequence or potter
syndrome.
3% had normal renal tract, 34% bilateral renal agenesis, 34% bilateral cystic
dysplasia, 9% unilateral agenesis with dysplasia, 10% minor renal abnormalities.
6. Locatelli A, Vergani P, Toso L. Verderio M., et al., “Perinatal outcome associated with
oligohydramnios in uncomplicated term pregnancies”. Dept. of OBG, University of
Milano-Bicocca Via Solferino 16, 2005. Monza, Italy.
341 out of 3049 women had AFI less than or equal to 5 and concluded that
oligohydramnios is associated with a higher risk of low birth weight centile.
7. Erika H. MD. et al., : 1999
A 4 month study showed that there is 2 fold increase in the incidence of adverse perinatal
outcome among the women with borderline AFI and 4 fold increase in incidence of IUGR.
8. Brain M. Casey, MD, et al., Dollas, Texas “Pregnancy outcomes after antepartum
diagnosis of oligohydramnios at or beyond 34 weeks gestation” Am. J. Obstet. Gynaecol.
2000 ; 182 : 909-12.
147 (2.3%) out of 6423 women had AFI < 5 cm. The complications observed were,
increased labour induction 42%, still birth 1.4%, Nonreassuring FHR 48%, NICU admission 7%,
Meconium aspiration syndrome 1%, Neonatal death 5%.
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9. Raj Sriya, Sunil Singhal, Manu Rajan et al., “Perinatal outcome in patients with Amniotic
Fluid index < 5 cm” J. of Obst and Gyn. Of India Vol. 51, No. 5 : Sept / Oct 2001, P. 98100.
A prospective case control study of 72 women, showed that nonreactive NST and FHR
showed inverse relationship with AFI. (36.11% in AFI < 5 cm). Low birth weight in 58.38%,
low apgar at 1 min 38.88%, NICU admission 88%.
10. Hill L.M., Oligohydramnios : Sonographic diagnosis and clinical implications. Clinical
Obstet. Gynecol. 1997 Jun ; 40 (2) : 314-327.
The incidence of structural malformations and aneuploidy with oligohydramnios ranges
between 7-37% and 4.4 – 30.7% respectively.
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APPENDIX –IC
6.3 OBJECTIVES OF STUDY
1. To study the perinatal outcome in cases of amniotic fluid index < 8 cms.
2. To evaluate the significance of amniotic fluid index in predicting the subsequent fetal
distress and operative interference.
Incidence :
The reported incidence of oligohydramnios varies between 0.5 - >5% depending on the
definition of oligohydramnios used and the population studied.
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APPENDIX-II
7.0 MATERIALS AND METHODS
APPENDIX-II A
7.1 SOURCE OF DATA
This study is being conducted at Sri Adichunchanagiri Hospital and Research Centre, B.G.
Nagara, from October 2008 onwards.
Study Group :
Consists of all women attending antenatal visits in Sri Adichunchanagiri Hospital and Research
Centre, B.G. Nagara, and those admitted to labour room with term and post term gestation.
APPENDIX-II B
7.2 METHOD OF COLLECTION OF DATA
Data will be collected with regards to age, demographic characteristics, socio economic
status, detailed history including patients complaints, duration of complaints, menstrual and
obstetric history, contraceptive history, significant past, family and personal history.
A detailed general physical examination will be done for built and nourishment, the blood
pressure pulse rate, absence / presence of pallor, icterus, clubbing of naily, lymphadenopathy,
pedaloedema systemic examination including CVS, RS and per abdominal examination for any
previous surgical scar.
Bimanual examination and necessary investigations will be done to diagnose the case.
Previous USG findings, indication for induction of labour and operative interference, nature of
amniotic fluid, NST are recorded.
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Fetal outcome i.e., weight of baby, apgar at 1st and 5th minute malformations, indications
for NICU admission such as low birth weight, fetal distress, pulmonary hypoplasia duration of
hospital stay, perinatal mortality, investigations and condition at discharge are noted down.
Study Design :
Pregnant women at term who were admitted for labour and delivery who had AFI < 8
composed the study group. The case patients were matched with control subjects for gravidity,
parity, gestational age, maternal complications including chronic hypertension, diabetes mellitus,
preeclampsia and IUGR.
Statistics :
For the statistical analysis of the study : Chi Square Test will be applied.
INCLUSION CRITERIA

Age of the mother 18-35 years.

Gestational age 37-42 weeks.

Singleton gestation with cephalic presentation.

AFI < 8 cm.

Intact membranes.
EXCLUSION CRITERIA

Gestational age < 37 weeks.

Associated fetal malformations

Ruptured membranes.

Multiple gestation.
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APPENDIX-II C
7.3 Does the study require any investigation or intervention to be conducted on the patients
or animals, if so please describe briefly
YES
Special investigations like Doppler flowmetry and any other investigation will be done if
indicated in a particular case.
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APPENDIX-III
8. LIST OF REFERENCES
1. Williams text book of Obstetrics, 22nd edition, F.Gary Cunningham, Kenneth. J. Leveno.
2. Brace R.A. Pitkin Roy M., Scot James R., Phriladelphia “Amniotic fluide regulators in
clinical obstetrics and gynecol” – Raven Publication 1997, 40 (2) : 280-9.
3. Arias Fernando. Practical guide to high risk pregnancy and delivery, 2 nd edition, MosbyYear book Inc. 1993 : 3-20, 150-159.
4. Ian Donald’s practical obstetric problems – Renu Misra , 6th edition.
5. Newbould MJ, Lendon M, Barron AJ : “Oligohydramnios sequence ; Spectrum of renal
malformation” Br. Journal Obstet Gynecol 101 : 598, 1994.
6. Locatelli A, Vergani P, Toso L. Verderio M., et al., “Perinatal outcome associated with
oligohydramnios in uncomplicated term pregnancies”. Dept. of OBG, University of
Milano-Bicocca Via Solferino 16, 2005. Monza, Italy.
7. Erika H. MD. et al., : 1999
8. Brain M. Casey, MD, et al., Dollas, Texas “Pregnancy outcomes after antepartum
diagnosis of oligohydramnios at or beyond 34 weeks gestation” Am. J. Obstet. Gynaecol.
2000 ; 182 : 909-12.
9. Raj Sriya, Sunil Singhal, Manu Rajan et al., “Perinatal outcome in patients with Amniotic
Fluid index < 5 cm” J. of Obst and Gyn. Of India Vol. 51, No. 5 : Sept / Oct 2001, P. 98100.
10. Hill L.M., Oligohydramnios : Sonographic diagnosis and clinical implications. Clinical
Obstet. Gynecol. 1997 Jun ; 40 (2) : 314-327.
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PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION A
a
“PERINATAL OUTCOME IN CASES OF
AMNIOTIC FLUID INDEX < 8
CENTIMETERS”
Title of the study
b
Principle investigator
(Name and Designation)
Dr. SOWMYA. K.N.
P.G IN OBSTETRICS AND GYNAECOLOGY,
ADICHUNCHUNAGIRI INSTITUTE OF
MEDICAL SCIENCES.B.G NAGARA,
MANDYA DISTRICT -571448
c
Co-investigator
(Name and Designation)
Prof. Dr. S. VIJAYALAKSHMI, M.D , D.G.O
Professor and Head,
Department of Obstetrics and Gynecology
AIMS, B.G. Nagara-571448
d
Name of the Collaborating
Department/Institutions
e
Whether permission has been obtained from
the heads of the collaborating departments &
Institution
DEPARTMENT OF RADIODIAGNOSIS,
AIMS, B.G.NAGARA
YES
Section – B
Summary of the Project
Section – C
Objectives of the study
APPENDIX I
Section – D
Methodology
DEPARTMENT OF O.B.G.,
A Where the proposed study will be undertaken
S.A.H. & R.C., B.G.NAGARA
2 YEARS
(OCTOBER 2008 TO SEPTEMBER 2010)
B Duration of the Project
C Nature of the subjects:
Does the study involve adult patients?
YES
Does the study involve Children?
NO
Does the study involve normal volunteers?
NO
Does the study involve Psychiatric patients?
NO
Does the study involve pregnant women?
YES
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D If the study involves health volunteers
I.
Will they be institute students?
NO
II.
Will they be institute employees?
NO
III. Will they be Paid?
NO
IV. If they are to be paid, how much per
NO
session?
E Is the study a part of multi central trial?
NO
F If yes, who is the coordinator?
(Name and Designation)
NA
Has the trail been approved by the ethics
Committee of the other centers?
-
If the study involves the use of drugs please
indicate whether.
-
I. The drug is marketed in India for the
NA
indication in which it will be used in the study.
II. The drug is marketed in India but not for
the indication in which it will be used in the
study
NA
III. The drug is only used for experimental use
in humans.
NA
IV. Clearance of the drugs controller of India
has been obtained for:
NA
 Use of the drug in healthy volunteers
 Use of the drug in-patients for a new
indication.
NA
 Phase one and two clinical trials
 Experimental use in-patients and healthy
volunteers.
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G How do you propose to obtain the drug to be
used in the study?
-
Gift from a drug company
-
Hospital supplies
-
Patients will be asked to purchase
-
Other sources (Explain)
NA
H Funding (If any) for the project please state
-
None
-
Amount
-
Source
-
To whom payable
NO
Does any agency have a vested interest in the
I
NO
out come of the Project?
Will data relating to subjects /controls be stored
J
NO
in a computer?
Will the data analysis be done by
K
-
The researcher?
-
The funding agent
YES
NO
L Will technical / nursing help be required form
NO
the staff of hospital.
If yes, will it interfere with their duties?
NO
Will you recruit other staff for the duration of
NO
the study?
If Yes give details of
I.
Designation
NA
II.
Qualification
NA
III.
Number
NA
IV.
Duration of Employment
NA
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M Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent?
YES, CONSENT WILL BE TAKEN FROM
Will it be taken from the subject themselves?
THE PATIENT
Will it be from the legal guardian? If no, give
reason:
N Describe design, Methodology and techniques
APPENDIX I
Ethical clearance has been accorded.
Chairman,
P.G Training Cum-Research Institute,
A.I.M.S., B.G.Nagara.
Date :
PS : NA – Not Applicable
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