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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