RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



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 |

| |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. |

| | |

| |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 |

| | |

| |To compare the various maternal and fetal risk factors with induction of labor with intravaginal prostaglandin E1 and |

| |intracervical prostaglandinE2 |

| |To compare induction delivery interval |

| |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. |

| |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: |

| |singleton live pregnancy |

| |cephalic presentation |

| |intact membranes |

| |patient with an indication for induction |

| | |

| | |

| |Exclusion criteria: |

| |antepartum haemorrhage |

| |cephalopelvic disproportion |

| |pregnancy with congenital malformations |

| |intrauterine death |

| |twins |

| |grand multipara |

| |malpresentations |

| |previous uterine scar |

| |abnormal fetal heart rate pattern before induction |

| |bronchial asthma, glaucoma patients |

| |. |

| |Statistical analysis: |

| |Data will be analysed using chi- square test, fisher exact test, student t test. |

| | 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. |

| |Has ethical clearance been obtained from your institution in case of 7.3 |

| | |

| |Yes |

| |References |

| |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. |

| | |

| |Adamsons K. Myers Re. Late decelerations and brain tolerance of the fetal monkey to intrapartum asphyxia. Am J Obstet Gyneco|

| |1997 ; 128: 893. |

| | |

| |Rayburn WF. Preinduction cervical ripening: basis and methods of current practice. Obstet Gynecol surv 2002 oct; 57 |

| |(10):683-92. |

| | |

| |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. |

| | |

| |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. |

| | |

| |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. |

| | |

| |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 ) |

| | |

| |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. |

| | |

| |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. |

| | |

| |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 |

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