SYNOPSIS

Rajiv Gandhi University of Health Sciences,

Bangalore, Karnataka.

TOPIC:

“PREGNANCY OUTCOMES AFTER DIAGNOSIS OF OLIGOHYDRAMNIOS AND

TREATMENT WITH INTRAVENOUS HYPERALIMENTATION AT RRMCH”

NAME OF THE CANDIDATE: Dr. Gayatri A

GUIDE: Dr. Nagarathnamma

COURSE AND SUBJECT: M.S.OBG

DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,

RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL,

BANGALORE - 560074

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION.

1. NAME : GAYATRI.A

2. ADDRESS : DEPARTMENT OF OBSTETRICS AND

GYNAECOLOGY

RAJA RAJESWARI MEDICAL

COLLEGE AND HOSPITAL

BANGALORE

3. NAME OF THE INSTITUTION : RAJA RAJESWARI MEDICAL

COLLEGE AND HOSPITAL

4. COURSE OF STUDY AND SUBJECT : MS OBSTETRICS AND

GYNECOLOGY

5. DATE OF ADMISSION TO COURSE : 28.05.2013

6. TITLE OF THE THESIS : PREGNANCY OUTCOMES AFTER DIAGNOSIS OF

OLIGOHYDRAMNIOS AND TREATMENT WITH

INTRAVENOUS HYPERALIMENTATION AT RRMCH

7. BRIEF RESUME OF INTENDED WORK:

7.1 NEED FOR THE STUDY

Assessment of presence and absence of oligohydramnios has been part of prenatal

sonographic evaluation for more than 15 yrs. Since that time much work has been focused on

determining the association of oligohydramnios with various adverse outcomes.

Decrease in amniotic fluid volume or Oligohydramnios has been correlated with increased

risk of intrauterine growth retardation, meconium aspiration syndrome, severe birth asphyxia,

low APGAR scores and congenital abnormities. Early detection of oligohydramnios and its

management may help in reduction of perinatal morbidity and mortality one side and

decreased caesarean deliveries and other complications during delivery on the other side.

7.2 REVIEW OF LITERATURE

The fluid that collects within amniotic cavity surrounding the embryo is called Amniotic

Fluid.(1)

Amniotic fluid provides a protected milieu for the growing fetus, cushioning the fetus against

mechanical and biological injury, supplying nutrients and facilitating growth and movement.

The quantity of amniotic fluid increases from 25 ml at 10 weeks to about 400ml at 20 weeks.

The composition of the amniotic fluid up to this period is identical to that of fetal plasma as

there is free diffusion of the fluid to and from the fetus. The fetal skin then begins to

keratinize, the process being completed by 25 weeks. Thereafter, the two major source of

amniotic fluid are fetal urine and lung secretions. Removal of fluid depends largely on fetal

swallowing and intramembraneous transport via the skin, placenta and cord surfaces. The

volume increases to about 800-1000ml at 28 weeks plateaus at term and declines to about

400ml at 42 weeks.(2)

Both an abnormal increase and decrease in the amniotic fluid volume have been associated

with increase maternal morbidity and prenatal morbidity and mortality.

When a single pocket in ultrasound <2cm in both vertical and horizontal plane(Mannning et

al) or AFI<5cm (Phelan) is defined as oligohydramnios, but Jeng et al proposed cut-off of

8cm demonstrated increased incidence of meconium staining, caesarean delivery, fetal

distress, APGAR 7 or less in one minute when AFI was < 8cm.(2)

The reported incidence of oligohydramnios varies between 0.5%- 5 % (2). The prevalence

depends largely upon the definition and criteria used for oligohydramnios and the population

studied. The common etiological factors associated with oligohydramnios are ruptured

membranes, congenital abnormalities and placental insufficiency. It is thought to be

associated with increased maternal and fetal morbidities. The perinatal morbidity and

mortality is due to a high risk of caesarean deliveries for mothers due to fetal distress, low

APGAR scores and meconium aspiration syndrome in the fetus. The possible explanation of

the increased Perinatal Morbidity and Mortality could be due to umbilical cord compression,

potential utero-placental insufficiency and the increased incidence of meconium stained

amniotic fluid and oligohydramnios. (1,2,3,4) RISKS ASSOCIATED WITH OLIGOHYDRAMNIOS(1,2,3,4)

MATERNAL FETAL

Proloned labour Abortion

Malpresentation Meconium aspiration syndrome

Cesarean delivery Septicemia

Instrumental delivery Fetal Pulmonary hypoplasia

Premature rupture of membrane Deformity (intra amniotic adhisions/compression)

Labour is protracted and contractions Cord compression

are more painful Perinatal mortality

This study is based on the articles several research projects on Oligohydramnios,

one being done by

“ Intravenous Amino Acids in Third Trimester Isolated Oligohydramnios” by

Dr.Fozia Umber Qureshi, Senior Registrar, Department of Obstetrics and Gynecology, Unit

1, Lady Willingdon Hospital, Ravi Road, Lahore , Pakistan and DR.Ahmed Wasim Yusuf,

Chairman and Professor, Department of Obstetrics and Gynecology, King Edward Medical

University and Department of Obstetrics and Gynecology, Unit 1, Lady Willingdon Hospital,

Ravi Road, Lahore , Pakistan. Methodology: Forty two women with singleton pregnancy,

well established gestational age and clinically and sonographically proven isolated

oligohydramnios in the third trimester before 36 weeks were administered amino acid

solution intravenously after excluding cases of premature rupture of membranes, congenital

anomaly of fetus, maternal pulmonary, cardio-vascular and hypertensive disorders, and

severe placental insufficiency (raised S/D ratio). Pre-infusion and post-infusion Amniotic

fluid Index (AFI) was measured and repeated weekly. Women were followed till delivery.

Result showed According to repeated measurement analysis of variance, mean pre-infusion

AFI was 4.7 cm, mean one week post-infusion AFI was 5.8 cm, mean two week post-infusion

AFI was 6.2 cm and mean three week AFI was 6.3 cm (p-value 0.029, significant). Cesarean

section became a predominant mode of delivery in this group without a firm evidence of

associated fetal compromise. Conclusion: Amino acid infusion is an effective therapy for

raising AFI in isolated oligohydramnios in this case series.(5)

“Intravenous maternal hydration in third trimester oligohydramnios: effect on

amniotic fluid volume”.Umber A, Chohan MA.Ministry of Population Welfare, Sir Gana

Ram Hospital, Lahore, Pakistan.(umber2001@hotmail.com) Twenty-five women with third

trimester oligohydramnios (AFI< or = 5.0 cm) and 25 controls with normal amniotic fluid

volume (AFI 8-24 cm) were prospectively recruited for this study. Study inclusion criteria

were, singleton pregnancy, well-established gestational age, intact membranes, absence of

maternal complication (anemia, cardiac disease, renal disease, pre-eclampsia, hypertension,

or diabetes); absence of fetal structural malformation and/or distress. Maternal urinary

specific gravity and amniotic fluid index were determined before and after intravenous

hydration by infusing 2 liters of 5%dextrose water in 2 hours and recorded on printed

proformas. Sample independent 't' test was used to compare the mean AFI and urine specific

gravity before and after treatment, and the posttreatment AFI-pre treatment AFI ( delta AFI).

RESULTS: Maternal hydration increased amniotic fluid volume (AFV) in women with

oligohydramnios (mean change in amniotic fluid index 4.5 cm, 95% confidence interval 4.02

to 5.06; p-value<0.01); as well as in women with normal amniotic fluid volume (mean

change in amniotic fluid index 2.7 cm, 95% confidence interval 2.23 to 3.21; p-value<0.01).

The percentage increase in mean AFI was 58.6% in the oligohydramnios group, which was

significantly greater (p<0.05) than the percentage increase of 28.4% in control group.

Maternal hydration was associated with decrease in urinary specific gravity in both

groups.Conclusion: Under the conditions of this study, maternal (intravenous) hydration

increased the AFV in women with oligohydramnios as well as in those with normal AFV and

may be beneficial in the management of oligohydramnios.(6)

“Oligohydramnios and Maternal Hydration Therapy” Jignesh Kansaria, Meghana Mathure, SV Parulekar, Department of Obstet and Gynaec, Seth GS Medical

College, KEM Hospital, Parel, Mumbai. 53 patients with oligohydramnios were advised maternal hydration therapy (at least 2 litres of oral fluids in a day) to

assess its effects on amniotic fluid volume and pregnancy outcome. Maternal hydration therapy plays an important role to improve Amniotic fluid volume (AFV)

in patients with oligohydramnios and also prevents occurrence of oligohydramnios in patients with IUGR and normal liquor volume.result showed

Oligohydramnios may be responsible for malpresentations, umbilical cord compression, concentration of meconium in the liquor and difficult or failed external

cephalic version. Simple maternal hydration appears to increase amniotic fluid volume and may be beneficial to reduce some of these problems.(7)

Rinoy Sreedharan, Shubhada Jajoo , Department of Obstetrics & Gynecology, Jawaharlal

Nehru Medical College, AVBRH, Sawangi, Meghe, Wardha, Maharashtra-442002, India,

studied “The effect of L-arginine on amniotic fluid index in oligohydramnios”, the study

prospective study conducted over a period of two years. A total of 100 women attending

antenatal clinic of Acharya Vinoba Bhave Rural Hospital, who were diagnosed with

oligohydramnios were included. Women who fulfilled the inclusion criteria were prescribed

sachets of L-arginine containing 3g of the active ingredient for periods varying between 1 to

4 weeks. Change in AFI was noted. Results showed L-arginine increases the amniotic fluid

index in cases of oligohydramnios by 2.03±0.39 cm and arrived at the conclusion that L-

arginine could be a potent treatment option for treatment of oligohydramnios. However

extensive long-term studies are required to demonstrate not only its efficacy but also effect on

maternal and perinatal outcome.(9)

Another study by Krishna Jagatia, Nisha Singh, Sachin Patel , Smt NHL Municipal Medical

College, Ahmedabad, Guajarat, India conducted a “Maternal and fetal outcomes in

oligohydramnios: a case study of 100 cases”.(8)

Study by Preshit Chate, Meena Khatri, C. Hariharan Department of Obstetrics &

Gynecology, Jawaharlal Nehru Medical College, AVBRH, Sawangi, Meghe, Wardha,

Maharashtra-442002, India, conducted a study on “Pregnancy outcome after diagnosis of

oligohydramnios at term”.(10)

Study by Nazlima Nargis, Assistant Professor, Department of Obstetric and Gynaecology, ibn

Sina Medical College Hospital. Fatema Begum, Professor, Department of Obstetric and

Gynaecology, ibn Sina Medical College Hospital. Conducted a study “Oligohydramnios at

third trimester and perinatal outcome”.(11)

7.3 MANAGEMENT OPTIONS

Management includes counseling the patient regarding the risks of decreased amniotic fluid.

Patient on admission with AFI < 8cm(2) were treated with intravenous hyperalimentation

(intravenous amino acid infusion and intravenous 10% invert sugar in saline), 3 doses on

alternate days a week.

7.4 OBJECTIVES OF THE STUDY

To compare the effect of the treatment in the increase of AFI and pregnancy outcomes after

treatment

8. MATERIALS AND METHODS:

Present study is a hospital based study and will be done over a period November 2013-March

2015 , patients with Oligohydramnios selected randomly after satisfying inclusion and

exclusion criteria. A detailed history and examination will be done.Gestational age will be

calculated using LMP or dating scan. Gestational ages ranged from 28 weeks to 37 weeks

will be considered. Amniotic fluid volume will be measured with four quadrant technique

which consist of measuring the largest pool of fluid devoid of cord and fetal parts, found in

each of the four quadrants of uterus. The sum of all the measurements will give AFI.

Obstetrical and systemic physical examinations will be conducted. Symphysio fundal height

will be measured in centimeters. Fetal movements and fetal heart rates will be recorded

serially. Blood investigations i.e. Hemoglobin, ABO grouping, Rh factor and Cell counts will

be carried out. Urinalysis and microscopy followed by culture / sensitivity will be done if

required. Initial obstetric sonography will be followed by estimation of umbilical artery blood

flow velocity and calculation of S/D ratio, there-by excluding severe placental insufficiency.

After taking informed consent, patients will be treated . Fetal kick counts and non-stress tests

will be performed as and when indicated. AFI measurements will be repeated weekly. Iron,

calcium and multi – vitamin supplements were continued orally as before. These women will

be followed till delivery. A predesigned study proforma will be filled for each case. Outcome

variables to be analyzed are Age, Parity, Gestational age at entry into the study, Pre-infusion

AFI, Post infusion AFI at week 1, week 2 and week 3, Gestational age at delivery, mode of

delivery, neonatal APGAR scores, birth weight and admission in Neonatal intensive care unit

(NICU).(5,6,7)

8.1 SOURCE OF DATA

All antenatal cases attending the OPD or admitted under OBG department , Raja Rajeshwari

medical college, Bangalore

PERIOD – November 2013 to March 2015

8.2 INCLUSION CRITERIA

Antenatal cases between 18yrs and 35 yrs diagnosed with oligohydramnios (AFI<8cm) with

singleton pregnancy with gestational from 28 -37 weeks.

8.3 EXCLUSION CRITERIA(5,6,7)

Pre existing or gestational diabetes

Multiple gestation

Fetal congenital anomalies

Pregnancy over 37 week of gestation

PROM

Cardiovascular disorder and maternal pulmonary disorder

Severe placental insufficiency

AFI<2cm

9. STATISTICAL ANALYSIS:

9.1 DESIGN OF STUDY: Obsesrvational Study

9.2 SAMPLING METHOD: Purposive sampling

9.3 DURATION OF STUDY: November 2013- March 2015

9.4 METHOD OF ANALYSIS: Paired “t” test

Data collected will be analyzed using descriptive statistics namely Mean and Standard

Deviation wherever necessary, results will be depicted in the form of tabular and graphical

representation. If necessary, for comparative purpose percentage can be used.

10.1 METHOD OF COLLECTION OF DATA

Pregnant females between 18yrs and 35 yrs of age as per the inclusion and exclusion criteria

will be included in the study. An informed consent will be taken from all the patients for

inclusion in the study

First thorough routine antenatal examination is done and by routine obstetric ultra

sonographic AFI is noted and treated accordingly

10.2 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO

BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO,

PLEASE DESCRIBE BRIEFLY.

Yes, on humans. Appropriate investigations and interventions performed wherever

indicated (ultrasound, cardiotocography, non stress test, blood investigations etc)

10.3 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN

CASE OF 10.2

Yes.

10.4 LIST OF REFERENCES

1. Mudaliar AL, Krishna Menon MK. Sarala Gopalan, Vanita Jain, editors. Mudaliar

And Menon’s Clinical Obstetrics . Tenth Edition. Chennai: Orient Longman Pvt Ltd;

2007. ISBN-13: 9788125028703

2. Ian Donald. Renu Misra MS, editor.Ian Donald’s Practical Obstetric Problems. Sixth

Edition. New Delhi:BI PublicationsPvt Ltd; 2012 ISBN-13:978-81-7225-238-0

3. Gary Cunningham F, Kenneth J Leveno , Steven L Bloom, John C Hauth, Dwight J

Rouse, Catherine Y Spong, editors. Williams Obstetrics. 23rd Edition.

The McGraw - Hill Companies;2010. ISBN 978-0-07-149701-5

4. Dutta D C. Hiralal Konar, Editor. Text Book Of Obstetrics including perinatology and

contraception. Sixth Edition.Calcutta: New Central Book Agency; 2004. ISBN-

13: 978-8173811425

5. Fozia Umber , Ahmed Wasim Yusuf .Intravenous Amino Acids in Third Trimester

Isolated Oligohydramnios. Annals of King Edward Medical University.2011;

17( 2):140-44.

6. Umber A, Chohan M A . Intravenous maternal hydration in third trimester

oligohydramnios: effect on amniotic fluid volume . J Coll Physicians Surg Pak. 2007

Jun;17(6):336-9. PMID: 17623581

7. Kansaria, Meghana Mathure, Parulekar SV. Oligohydramnios and Maternal

Hydration Therapy. [cited 2013 November 5].Available from:

http://www.bhj.org.in/journal/2005_4704_oct/html/original_oligohydramnios_389-

393.htm

8. Krishna Jagatia, Nisha Singh, Sachin Patel. Maternal and fetal outcome in

oligohydramnios : a study of 100 cases. International Journal of Medical Science and

Public Health. 2013; 2(3): 476-477. DOI:10.5455/ijmsph.2013.070520132.

9. Sreedharan R, Jajoo S. Effect of L-arginine on amniotic fluid index in

oligohydramnios. Int J Reprod Contracept Obstet Gynecol. 2013; 2(1): 80-82.

DOI:10.5455/2320-1770.ijrcog20130214

10. Chate P, Khatri M, Hariharan C. Pregnancy outcome after diagnosis of

oligohydramnios at term. Int J Reprod Contracept Obstet Gynecol. 2013; 2(1): 23-

26.DOI:10.5455/2320-1770.ijrcog20130204

11. Nazlima N, Fatima B. Oligohydramnios at third trimester and perinatal outcome

Bangladesh Journal of Medical Science 2012; 11(1): 33-36.

DOI:  http://dx.doi.org/10.3329/bjms.v11i1.9820

11. SIGNATURE OF CANDIDATE

12. REMARKS OF THE GUIDE: Being a tertiary care centre, we are getting good

number of High Risk Pregnancy cases specially Oligohydramnios.This study will be of

great help to compare the outcomes after treatment with hyperalimentation and to decide

at right time and plan for delivery at the earliest so that major maternal & perinatal

mortality and morbidity can be prevented.

13. NAME AND DESIGNATION OF

GUIDE: Dr. NAGARATNAMMA

PROFESSOR AND HOD

DEPARTMENT OF OBSTETRICS

AND GYNAECOLOGY

RAJA RAJESHWARI MEDICAL

COLLEGE, BANGALORE

SIGNATURE:

14. HEAD OF DEPARTMENT: Dr.NAGARATNAMMA

PROFESSOR AND HOD

DEPARTMENT OF OBSTETRICS

AND GYNAECOLOGY

RAJA RAJESHWARI MEDICAL

COLLEGE, BANGALORE

SIGNATURE

15. REMARKS OF THE CHAIRMAN AND PRINCIPAL

SIGNATURE

ETHICALCOMMITTEE CLEAREANCE

1. TITLE OF DISSERTATION

: “ Pregnancy outcomes after Diagnosis of

Oligohydramnios and Treatment with

Intravenous Hyperalimentation at RRMCH”

2. NAME OF THE CANDIDATE

: Dr.GAYATRI A

3. NAME OF THE GUIDE : Dr. Dr. NAGARATNAMMA

PROFESSOR AND HOD

DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, RAJA RAJESWARI MEDICAL COLLEGE AND HOSPITAL,BANGALORE

4. APPROVED/NOT APPROVED

YES

SUPERINTENDENT

Raja rajeswari medical college and hospital

Bangalore

PROFESSOR & HOD

Department of OBG

Rajarajeswari Medical College and HospitalBangalore

DEAN AND DIRECTOR

Raja rajeswari medical college and hospital

From

Dr.Gayatri A

Post-Graduate in Obstetrics and Gynaecology

Department of Obstetrics and Gynaecology

Rajarajeswari medical college and hospital,Bangalore

To

Registrar (Evaluation)

Rajiv Gandhi University of Health Sciences,Bangalore

THROUGH PROPER CHANNEL

Respected Sir,

Subject: Submission of Synopsis titled

Pregnancy outcomes after Diagnosis of Oligohydramnios and Treatment with

Intravenous Hyperalimentation at RRMCH

I am hereby submitting the above titled synopsis (4 copies)as mentioned above, so

kindly accept my application and do the needful

Thanking you

Yours faithfully

(Dr.Gayatri A)

Forwarded to Dean and Director, Raja rajeswari medical college and hospital for further

needful action

PROFESSOR AND HEAD

Date Department of Obstetrics and Gynaecology

Place: Bangalore Raja rajeswari medical college and hospital, Bangalore

APPENDIX I

INI TIA LS

CONSENT FORM

STUDY TITLE

“Pregnancy outcomes after Diagnosis of Oligohydramnios and Treatment with

Intravenous Hyperalimentation at RRMCH.”

1. I have been explained and have understood the procedures involved in the study

2. I confirm that I have read and understand the information sheet for the above study.

3. I have had the opportunity to consider the information, ask questions and have had

these answered satisfactorily.

4. I understand that my participation is voluntary and that I am free to withdraw at any

time, without giving any reason, without my medical care or legal rights being

affected.

5. I understand that relevant sections of any of my medical notes and data collected

during the study may be looked at by responsible individuals from [Raja rajeshwari

Medical College], where it is relevant to my taking part in this study. I give

permission for these individuals to have access to my records.

6. I agree to take part in the above study.

Name and signature of interviewer Signature of subject

Date: Date