SYNOPSIS

OF

DISSERTATION

DR . BHIMA HARIKA

DEPARTMENT OF OBG

VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTER,

WHITEFIELD, BANGALORE.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BENGALURU, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / Name of the candidate and address (in block letters) / DR.BHIMA HARIKA
DEPARTMENT OF OBG,
VYDEHI INSTITUTE OF MEDICAL SCIENCES & RESEARCH CENTRE, WHITEFIELD , BANGALORE.
2 / Name of the Institution / VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
BANGALORE - 66
3 / Course of the study and subject / MS (OBSTETRICS AND GYNAECOLOGY)
4 / Date of admission to course / 25th MAY, 2012
5 / Title of topic:
RANDOMISED COMPARATIVE CLINICAL STUDY OF THE EFFICACY AND SAFETY OF INTRACERVICAL PROSTAGLANDIN E2 WITH INTRAVAGINAL PROSTAGLANDIN E1 IN INDUCTION OF LABOR AND ITS OBSTETRICS OUTCOME.
6 / Brief resume of the intended work
6.1  Need for the study
Induction of labor is the nonspontaneous initiation of uterine contractions, prior to their spontaneous onset leading to progressive effacement and dilatation of cervix and delivery of the baby.
Labor is a stress factor for the fetus. During active labor the integrity of the uteroplacental circulation and the frequency and intensity of uterine activity influence the acid base status of the fetus which is reflected in the fetal heart tracings on cardiotocograph1. Fetal heart rate monitoring is sensitive sufficient to diagnose fetal asphyxia before permanent brain damage occurs2.
15%of pregnant women require aid in cervical ripening and labor induction. Half of them will have an unfavorable cervix a topically applied prostaglandin, containing either prostaglandin E2 or prostaglandin E1 is the most popular means to soften and dilate the cervix3.
Few studies have been done with 6th hourly 25ug misoprostol, more over misoprostol is cheaper , easier to store and stable at room temperature, hence the need for the study. The aim of study is to compare efficacy and safety of prostaglandinE1 and prostaglandin E2 in induction of labor to achieve vaginal delivery and reduce caesarian section. The neonate should be delivered in a good condition with minimum maternal side effects.
6.2  Review of literature:
In 2012, N S Chitrakar compared misoprostol versus dinaprostone for preinduction cervical ripening at term and concluded that 25ug dose of misoprostol is superior in promoting cervical ripening, significantly shortened the induction delivery interval. It is safe and effective for cervical ripening when applied in the hospital setting with close monitoring4.
In 2011, P.Saxena et al stated that intravaginal misoprostol 50ug administered 6hrly appears to be most effective as it has least induction to delivery interval time, has maximum improvement in Bishop score, least oxytocin requirement without any increase in complication rate5.
In 2011, Leo Pevzner et al concluded that cardiotocographic abnormalities were less frequent and occurred after longer exposure with MVI50 than MVI100 or dinaprostone. Clinical outcomes were similar among the groups6.
In 2008, K S Krithika et al stated that intravaginal misoprostol 25ug 4hrly is safe and effective for induction of labor with shorter induction to delivery interval when compared to intracervical cerviprime7.
In 2007, Denguezli W et al compared efficacy and safety of intravaginal misoprostol versus dinoprostone cervical gel for cervical ripening and labor induction and concluded that misoprostol is more effective than dinoprostone gel application. There is tendency for an increase in the rate of tachysystole and hyperstimulation syndrome8.
In 2006, Murthy Bhaskar Krishnamurthy et al compared efficacy , safety, cost and fetal outcome of misoprostol with that of combination of dinoprostone and oxytocin for induction of labor and concluded that induction delivery interval was significantly shorter, fetal distress was common, cost of therapy was effective and inexpensive in the misoprostol goup9.
In 2005, Ramsey PS et al in their study on CTG abnormalities associated with dinoprostone and misoprostol cervical ripening have concluded that misoprostol is more efficacious than dinoprostone for labor induction. There is significantly increased incidence of abnormal FHR tracings and the trend in increased cesarean deliveries for fetal distress with misoprostol10.
6.3 Objectives of the study
1)  To compare the various maternal and fetal risk factors with induction of labor with intravaginal prostaglandin E1 and intracervical prostaglandinE2
2)  To compare induction delivery interval
3)  To compare outcome of induction of labor – mode of delivery.
7 / Materials and Methods
7.1 Source of data
Study design: Randomized comparative clinical trial
100 pregnant women admitted for safe confinement in the department of Obstetrics and Gynecology, Vydehi Institute of Medical Sciences from January 2013 to June 2014.
50 will be induced with intravaginal prostaglandin E1 and 50 will be induced with intracervical prostaglandinE2.
7.2  Method of collection of data (including sampling procedure if any)
Definition of a subject study: pregnant women not in labor
The method of study consists of-
·  Detailed history with examination.
·  Non Stress Test as an admission test.
·  Bishop score assessment.
·  Induction with intravaginal prostaglandin E1 25ug 6hrs apart to maximum of 5 doses and intracervical prostaglandin E2 0.5mg 6hrs apart to maximum of 3doses alternately.
·  Patients with established uterine contractions of greater than 3 contractions in 10min will not be re-dosed.
·  Cardiotocograph in active labor.
·  Oxytocin augmentation if needed.
·  Artificial rupture of membranes done in active labour.
·  Progress, total duration of labour assessed using partogram.
·  Mode of delivery.
·  Assessment of the baby using APGAR score
·  Investigations done and the treatment given will be recorded and the neonate followed up until discharge.
Inclusion criteria:
a)  singleton live pregnancy
b)  cephalic presentation
c)  intact membranes
d)  patient with an indication for induction
Exclusion criteria:
a)  antepartum haemorrhage
b)  cephalopelvic disproportion
c)  pregnancy with congenital malformations
d)  intrauterine death
e)  twins
f)  grand multipara
g)  malpresentations
h)  previous uterine scar
i)  abnormal fetal heart rate pattern before induction
j)  bronchial asthma, glaucoma patients
.
Statistical analysis:
Data will be analysed using chi- square test, fisher exact test, student t test.
7.3  Does the study require any investigations or interventions to be conducted on patients or other humans or animal? If so, please describe briefly.
Yes, the present study requires the following specific investigations and interventions:
·  Intrapartum cardiotocographic tracing.
·  Artificial rupture of membranes done in active labour( if membranes are not spontaneously ruptured)
These investigations will be conducted once an informed consent is taken from the patient.
7.4  Has ethical clearance been obtained from your institution in case of 7.3
Yes
References
1.  Megalo A, Petignat P, Hohlfeld P. influence of misoprostol or prostaglandin E2 for induction of labor on the incidence of pathological CTG tracing: a randomized trial. Eur J Obstet Gynecol Reprod Biol 2004 ; 116 (1): 34-38.
2.  Adamsons K. Myers Re. Late decelerations and brain tolerance of the fetal monkey to intrapartum asphyxia. Am J Obstet Gyneco 1997 ; 128: 893.
3.  Rayburn WF. Preinduction cervical ripening: basis and methods of current practice. Obstet Gynecol surv 2002 oct; 57 (10):683-92.
4.  N S Chitrakar. Comparison of misoprostol versus dinoprostone for preinduction cervical ripening at term. Journal of Nepal health research council 01/2012;10(1):10-5.
5.  P.Saxena, M.Puri, M.Bajaj, A.Mishra, SS Trivedi: A randomized clinical trial to compare the efficacy of different doses of intravaginal misoprostol with intracervical dinoprostone for cervical ripening and labor induction. European review for medical and pharmacological sciences (impact factor.104). 07/2011;15(7):759-63.
6.  Leo pevzner, Zarko Alfirevic, Barbara L.Powers, Deborah A.Wing: Cardiotocographic abnormalities associated with misoprostol and dinoprostone cervical ripening and labor induction. European journal of Obstetrics & Gynaecology and Reproductive Biology volume 156, issue 2, pages 144-148, June 2011.
7.  KS Krithika, N Agarwal, Vsuri: Prospective randomized controlled trial to compare safety and efficacy of intravaginal misoprostol with intracervical cerviprime for induction of labor with unfavourable cervix. Journal of Obstetrics and Gynaecology: the journal of the institute of Obstetrics and Gynaecology (impact factor:0.43). 05/2008; 28(3):294-97. (DOI:10. 1080/01443610802054972 )
8.  Denguezli W, Trimech A, Haddad A, Hajjaji A, Saidani Z, Faleh R, Sakouhi M. efficacy and safety of six hourly vaginal misoprostol versus intraccervical dinoprostone: a randomized controlled trial. Arch Gynecol Obstet. 2007 Aug: 276 (2): 119-24.
9.  Murthy Bhaskar Krishnamurthy, Arkalgud Mangala Srikantaiah Misoprostol alone versus a combination of dinoprostone and oxytocin for induction of labor journal of obstetrics and gynecology of India vol:56, No:5, October, 2006 P413-416.
10. Ramsey PS, Meyer L, Walkes BA, Harris D, Ogburn PL Jr, Heise RH, Ramin KD. Cariotocographic abnormalities associated with dinoprostone and misoprostol cervical ripening. Obstet Gynecol 2005; 105(1):85-90.
9 / Signature of the candidate
10 / Remarks of the guide
The study is significant as misoprostol is cost effective and easier to administer.
11 / Name and designation of the guide (in block letters)
11.1 Guide DR.SAMPATH KUMAR
Professor
Department of OBG,
VYDEHI INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH
CENTRE,WHITEFIELD,
BANGALORE.
11.2 Signature
11.3 Head of the Department DR .SREEDHAR VENKATESH
Professor and Head of the Department,
Department of OBG,
VYDEHI INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH
CENTRE,WHITEFIELD,
BANGALORE.
11.4 Signature
12 / 12.1 Remarks of the Chairman & Principal
12.2 Signature