Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s3

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

SYNOPSIS OF DISSERTATION

"CLINICAL STUDY OF MATERNAL AND FETAL OUTCOME IN PRELABOUR RUPTURE OF MEMBRANES AT TERM IN RURAL SCENARIO"

Submitted by Dr. PUSHPALATA 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 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 NAME OF THE CANDIDATE Dr. PUSHPALATA AND ADDRESS P.G IN OBSTETRICS & GYNAECOLOGY, (in block letters) ADICHUNCHUNAGIRI INSTITUTE OF MEDICAL SCIENCES.B.G NAGARA, MANDYA DISTRICT -571448 ADICHUNCHANAGIRI INSTITUTE OF 2. NAME OF THE INSTITUTION MEDICAL SCIENCES, B.G.NAGARA.

3. COURSE OF STUDY AND SUBJECT M.S. IN OBSTETRICS & GYNAECOLOGY

4. DATE OF ADMISSION TO COURSE 31st MAY 2012

"CLINICAL STUDY OF MATERNAL 5. TITLE OF THE TOPIC AND FETAL OUTCOME IN PRELABOUR RUPTURE OF MEMBRANES AT TERM IN RURAL SCENARIO" 6. BRIEF RESUME OF INTENDED WORK APPENDIX-I 6.1 NEED FOR THE STUDY APPENDIX-IA 6.2 REVIEW OF LITERATURE APPENDIX-IB 6.3 OBJECTIVES OF THE STUDY APPENDIX-IC 7 MATERIALS AND METHODS APPENDIX-II

7.1 SOURCE OF DATA APPENDIX-IIA

7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING APPENDIX-IIB PROCEDURE IF ANY)

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS YES TO BE CONDUCTED ON PATIENTS OR APPENDIX-IIC OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.

7.4 HAS ETHICAL CLEARENCE BEEN YES OBTAINED FROM YOUR INSTITUTION APPENDIX-IID IN CASE OF 7.3

8. LIST OF REFERENCES APPENDIX – III

2 9. SIGNATURE OF THE CANDIDATE

The study is necessary to determine the causes 10. REMARKS OF THE GUIDE of pre labour rupture of membranes and to study its impact on maternal and fetal outcome. NAME AND DESIGNATION 11 (in Block Letters)

11.1 GUIDE 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) -

11.4 SIGNATURE -

11.5 HEAD OF DEPARTMENT Dr. S. VIJAYALAKSHMI, M.D , D.G.O Professor and Head Department of Obstetrics and Gynecology AIMS, B.G. Nagara-571448

11.6 SIGNATURE

12 12.1 REMARKS OF THE CHAIRMAN The facilities required for the investigation AND PRINCIPAL will be made available by the college

Dr. M.G SHIVARAMU M.B.B.S., MD PRINCIPAL, AIMS, B.G. NAGARA.

12.2 SIGNATURE

3 APPENDIX-I

6. BRIEF RESUME OF THE INTENDED WORK:

APPENDIX-1A

6.1.NEED FOR THE STUDY

This study is done to know fetal and maternal outcome in prelabour rupture of membranes at term. And to identify the factors helping in optimizing the outcome for both maternal and fetal outcome in rural scenario.

APPENDIX –I B

6.2 REVIEW OF LITERATURE

Vaishnav et al conducted prospective case control study on PROM after 37 completed weeks showed incidence of PROM was 8.09%. Mean PROM-delivery interval 11.67 hrs in induced versus 8.05 hrs in spontaneous group. Neonatal C-reactive protein was positive in

30.30% neonates, 20 babies had C-reactive protein positive, 2 had raised total count in case group, 1 baby with MBA, kept in NICU, for observation.1

Shreshta et al conducted a prospective case control study showed major risk factors for

PROM are antecedent coitus, hydraminos, smoking, cephalo-pelvic disproportion, previous abortion. Normal delivery occurred in 70% of PROM cases, 93% normal delivery occurred in non pre labour membranes, 49 pregnant women with PROM received antibiotics and 24 babies developed infection, and only one developed infection in patient with non prelabour rupture of membranes.2

Shah et al conducted prospective case control study showed that the confirmation of

PROM was confirmed by leaking of clear fluid in per speculum examination and fern test whenever required.

4 In neonates serum c-reactive protein and blood culture and sensitivity is done in all cases if PROM interval more than 18 hours. If C-reactive protein positive iv injectable antibiotics is given to the baby and if blood culture and sensitivity is positive iv antibiotics is continued for 14 days. In case group 15 neonates were C-reactive protein positive in control group 2 babies were c-reactive protein positive. In study group one baby had moderate birth asphyxia.3

Ohonsi et al conducted a prospective case control study of 200 women compared outcome of labour in women who had immediate induction of labour, with those who had delayed induction following SPROM at term. Results showed immediate induction of labour with intravaginal misoprostol resulted lower rates of caesarean section and operative vaginal delivary.4

Fauzia Monnoo Khan conducted a retrospective case study, 100 patients with prolonged rupture of membranes for more than 24 hours 84% patients admitted through emergency mode of delivery was vaginal 80% of cases. Risk of neonatal infection was increased among mothers colonized with group B streptococcus and in babies whose mothers had fever during labour, and prelabour rupture membranes more than 18 hours.5

James et al., stated the incidence of sub-clinical chorioamnionitis is 30%. Abruption placenta is evident in 4-7%. The increase in operative delivery associated with PROM increases maternal morbidity. Incidence of endomyometritis is 10% with PROM. Although incidence of chorioamnionitis is 30%, neonatal sepsis is 2-4%. Fetal hypoxia is due to cord prolapsed, cord compression, abruption placenta which are inturn due to PROM. Pathologic examination of placentae associated with PROM demonstrates an increased incidence of marginal cord insertion and battledore placenta which leads to primary and secondary postpartum haemorrhage.6

5 Gabbe et al., stated that infection of amniotic cavity is the commonest complication of

PROM. 9% gravidas with PROM develop chorioamnionitis. This increases to 24%, with membrane rupture longer than 24 hours fetal complications include infection and fetal distress due to umbilical cord compression or placental abruption. Fetal death occurs in 1-2%.7

D.C. Dutta, defines PROM as spontaneous rupture of membranes any time after 37 weeks but before onset of labour is called term PROM. It occurs in 10% of all pregnancies. It leads to maternal morbidities and fetal morbidities and mortalities if labour fails to start within

24 hours after rupture of membranes the investigations to detect maternal and fetal outcome can be done are full blood count, urine for routine analysis, high vaginal swab culture and sensitivity, urine for routine analysis and culture, cardiotocography for NST test.8

APPENDIX –IC

6.3 AIMS AND OBJECTIVES OF STUDY

1. To identify risk factors.

2. To compare the outcome of pregnancy between patients with PROM and without

3. To study the

a. Maternal morbidity

b. Maternal mortality

c. Perinatal morbidity

d. Perinatal mortality

6 APPENDIX-II

7.0 MATERIALS AND METHODS

APPENDIX-II A

7.1 SOURCE OF DATA

This study will be carried out in the department of Obstetrics and Gynaecology, Sri

Adichunchanagiri Institute of Medical Sciences, B.G. Nagara. The number of cases which are admitted with clinically the provisional diagnosis as prelabour rupture of membranes > 37 weeks of gestation. All these cases were admitted in our hospital for further management and outcome

Study Design : A prospective case control study

Study Period : 24 Months (September 2012 to November 2014)

APPENDIX-II B

7.2 METHOD OF COLLECTION OF DATA

INCLUSION CRITERIA

 Cases admitted with PROM at >37 weeks of gestation.

 Cervical dilatation of < 3cm

 Lack of uterine contraction for atleast 1 hour of PROM

 Single ton pregnancy

 Vertex presentation

 Reactive NST

 Clear liquor

7 EXCLUSION CRITERIA

 Cases admitted with PROM < 37 weeks of gestation

 Cervical dilatation >3cm

 Uterine contraction within 1 hour of PROM

 Multiple pregnancy

 Mal presentation

 Non reactive NST

 Meconium stained liquor

 History of previous LSCS

 Any other medical complications.

Procedure of Study :

 A detailed history will be obtained regard to age, parity, socio-economic status,

antenatal check up, duration of rupture of membranes, liquor colour, odour onset of

labour pain.

 Presence of antenatal risk factors like white discharge per vaginum, UTI, Genital tract

infection, history of recent coitus, past history of PROM are noted

 A thorough clinical examination including general physical examination, built,

nutritional status, height, weight. Blood pressure and pulse along with absence or

presence of pallor and pedal edema.

 The CNS, CVS, RS are examined.

 Abdominal examination is done for height of uterus in weeks, the lie of fetus,

presentation and position of the fetus, rate of fetal heart, whether head is engaged or not

is noted.

8  A detailed pelvic examination is done under aseptic precaution.in per speculum

examination, look for any discharge, leaking p/v, colour of liquor. Then take a swab

from amniotic fluid for gram stain culture and sensitivity and send the mother blood for

C-reactive protein.

A detailed per vaginal examination done to determine the consistency, effacement, dilatation of cervix, position of cervix and presence or absence of membranes are noted, the station of the vertex with its position, the presence of caput, molding and type of pelvis noted

The following are noted

MATERNAL OUTCOME

 Fever

 Total WBC count

 Serum C-Reactive protein levels

 Vaginal swab of amniotic fluid for gram stain

 Vaginal swab of amniotic fluid culture and sensitivity

 Wound gap of LSCS or episiotomy

IF PROM INTERVAL MORE THAN 12 HOURS

FETAL OUTCOME

 C-Reactive protein levels

 Blood culture and sensitivity

 Antibiotic treatment

 Moderate birth asphyxia/severe birth asphyxia

 Conjuctival discharge

Statistical Analysis Done by :

Appropriate statistical methods proposed for the study will be applied.

9 10 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

Investigation :

FOR MOTHER

 Serum C-reactive protein level

 Vaginal swab for amniotic fluid gram stain

 Vaginal swab of amniotic fluid culture and sensitivity

 Total count

FOR NEONATE IF PROM INTERVAL IS MORE THAN 12 HOURS

 C-reactive protein level

 Blood culture and sensitivity

11 APPENDIX-IID

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A "CLINICAL STUDY OF MATERNAL AND FETAL OUTCOME IN PRELABOUR a Title of the study RUPTURE OF MEMBRANES AT TERM IN RURAL SCENARIO" Dr. PUSHPALATA P.G IN OBSTETRICS AND GYNAECOLOGY, Principle investigator b (Name and Designation) ADICHUNCHUNAGIRI INSTITUTE OF MEDICAL SCIENCES.B.G NAGARA, MANDYA DISTRICT -571448

Dr. S. VIJAYALAKSHMI, Co-investigator M.D , D.G.O c Professor and Head (Name and Designation) Department of Obstetrics and Gynecology AIMS, B.G. Nagara-571448 Name of the Collaborating d MICROBIOLOGY Department/Institutions

Whether permission has been obtained from e the heads of the collaborating departments & YES Institution Section – B Summary of the Project Section – C APPENDIX – I Objectives of the study Section – D Methodology DEPARTMENT OF O.B.G., A Where the proposed study will be undertaken S.A.H. & R.C., B.G.NAGARA B Duration of the Project 24 MONTHS C Nature of the subjects: Does the study involve adult patients? YES Does the study involve Children? YES Does the study involve normal volunteers? YES Does the study involve Psychiatric patients? NO Does the study involve pregnant women? NO

12 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 YES 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 NA study

III. The drug is only used for experimental use in humans. NA

IV. Clearance of the drugs controller of India NA has been obtained for:

 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.

13 G How do you propose to obtain the drug to be used in the study? - Gift from a drug company NA - Hospital supplies - Patients will be asked to purchase - Other sources (Explain) H Funding (If any) for the project please state - None - Amount NO - Source - To whom payable

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? YES - The funding agent NO L Will technical / nursing help be required form YES 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 LAB TECHNICIAN II. Qualification M.L.T III. Number 02 IV. Duration of Employment 05 Years

14 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

15 APPENDIX-III

8.LIST OF REFERENCES

1. Jolly Vaishnav, Gunvant Vaishnav : A study of feto-maternal outcome in patients with

prelabour rupture of membranes at term (> 37 weeks). Prelabour rupture of membranes

(PROM), 1 (2), 2012, Pg. 118-24.

2. Sita Ram Shrestha, Paba Sharma : Fetal outcome of pre-labour rupture of membranes,

Emergency unit and Dept. of Obs. Gyn. Vol. 1, No. 2, Nov-Dec 2006, Pg. 19-24.

3. M. Shah, P. Sandesara : Fetomaternal outcome in cases of premature rupture of

membrane (PROM). A case control study. Vol. 66, No. 1, Feb. 2011, Pg. 36-38.

4. A.Omole-Ohonsi, A. Shimi, S. Adeleke : Spontaneous Pre-labour rupture of

membranes at term : Immediate versus delayed induction of labour. West African

Journal of Medicine, Vol. 28, No. 3, May 2009, Pg. 156-160.

5. Fauzia Monnoo Khan : Maternal and neonatal outcome after prolonged rupture of

membranes. Dept. of Obst & Gynecol. Pg. 1-3.

6. JAMES, STEER, WEINER GONIK, CROWTHER, ROKSON : High risk pregnancy.

Edn. 4th, Pg. 1091-1100.

7. Steven G. Gabbe, Jennifer R. Niebyl, Joe Leigh Simpson : Obstetrics normal and

problem pregnancies. 5th edition, Pg. 713-732.

8. D.C. DUTTA : Text book of obstetrics. 7th edition, Pg. 314-326.

16 PROFORMA

Clinical study of fetal and maternal outcome in prelabour rupture of membranes at term in rural scenario

Serial no : Hospital No. :

Name : Occupation :

Address :

SOCIO- ECONOMIC STATUS :

1. CHIEF COMPLAINTS :

2. HISTORY OF PRESENTING COMPLAINTS :

A) H/O : P.V Leak

Duration : Hrs Min

Interval :

Quantity : Scanty / Moderate /Excessive

B) H/O: Pain Abdomen

1.Yes duration Hrs Min

Fetal movements

1. Yes

C) Previous history of

1. PROM

2. Preterm delivery

3. UTI

4. Cervical incompetence

5. Cervical surgery

17 D) Present history of

1. Coitus

2. Antipartum hemorrhage (threatened abortion)

3. Polyhydraminos

4. Cervical length 2.5 cm

5. Pelvic examination before term

3. OBSTETRIC HISTORY :

Married Life : Para : Living :

Abortion : Last Delivery :

Type of Deliveries:

4. MENSTRUAL HISTORY :

Age of Menarche :

Flow :

Clots :

Dysmenorrhoea :

LMP : Wks. Days

EDD : Wks. Days

5. PAST HISTORY :

TB / Bronchial asthma/ RHD/Blood transfusion / Any operations

6. FAMILY HISTORY :

TB / Bronchial Asthma / Diabetes mellitus / Hypertension / Any cancer / Bleeding

disorders / Thyroid disorders

7. PERSONAL HISTORY :

Diet :

Appetite :

Bowels :

Micturation :

18 Sleep :

Excessive intake of coffee :

8. EXAMINATION OF PATIENT:

On examination

1. Nutrition status

2. Height in cms

3. Weight in kgs

4. Temperature in degree

5. BP in mm of Hg

6. Respiratory rate per minute

7. Pulse bpm

8. Pallor

9. Edema

10. Icterus

Systemic examination

a. CVS

c. Per abdomen

 SFH

 EFW

 Activity

 presentation

 Auscultation

 Liquor volume

19 Speculum examination

a. Colour of liquor

b. Foul smelling

- P/v examination

- Cervix dilatation

- Length of the cervix

- Effacement

- Consistency

- Vertex station

- Membranes

Investigations

2. Blood grouping

3. VDRL

4. HIV

5. HBsAG

6. CRP

7. Amniotic fluid swab culture and sensitivity

8. NST

Management

a. Antibiotics

Ampicillin/Sulbactem

Amoxicillin

Erythromycin

Gentamycin

Metrogyl

20 b. Induction with misoprostol

25 microgram

50 microgram

75 microgram

>100 microgram

Total doses c. APGAR at

1 min.

5 min. d. Weight in grams

<2.5 kg

2.5-3.5kg

>3.5kg e. NICU admissions

a. Indication

Pre term

Small for date

Birth asphyxia

Meconium aspiration

Jaundice

Others

b. Duration of days

Baby condition at the time of discharge from NICU f. CRP g. Blood culture report h. Total count i. Jaundice

21 j. Duration of labour

stage 1

stage 2

stage 3 k. Induction to delivery interval l. PROM to delivery interval

<6 hours

6-11 hours

12-17 hours

18-23 hours

>24 hours m. Type of delivery

1. Normal

2. Forceps

3. ventouse

4. LSCS n. Indication for LSCS

1. Failed induction

2. Fetal distress

3. CPD

4. Failure to progress

5. Cord prolapse

6. Others o. Neonatal

1. Sex

2. Date of birth

3. Phototherapy

22 4. Exchange transfusion

5. Other complications

 Septicemia  Hypoglycemia  Hypothermia  Meningitis  RDS  Meconium aspiration  Umbilical sepsis

6. Antibiotics

7. Postnatal complications of mother

 Febrile morbidity  Chorioamnionitis  Endometritis  Epsiotomy complications  UTI  DVT  Duration of hospital stay

8. Any other conditions of the baby

9. Any other conditions

10. Baby

 Alive  Dead