RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE, KARNATAKA

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1 |Name of the Candidate and Address (in Block Letters) |Dr. KIRTI M. HURAKADLI |

| | |D/o B.M. HURAKADLI |

| | |‘NANDI’ |

| | |NEAR WATER TANK |

| | |BHAGWAN SHRI MAHAVIR ROAD |

| | |BAGALKOT-587101 |

| | |KARNATAKA. |

|2 |Name of the Institution |J.J.M. MEDICAL COLLEGE |

| | |DAVANGERE – 577 004, KARNATAKA |

|3 |Course of Study and Subject |Post-graduate |

| | |M.S. IN OBSTETRICS AND GYNAECOLOGY |

|4 |Date of Admission to Course |03-05-2010 |

|5 |Title of the Topic |“PARTOGRAPHIC COMPARISION OF SPONTANEOUS LABOUR WITH OXYTOCIN AND|

| | |PROSTAGLANDIN INDUCED LABOUR” |

|6 |Brief Resume of the intended work: |

| |Need for the study: |

| |More than 22% of all gravid women undergo induction of labour in the US, the overall rate of which has more than doubled |

| |since 1990 to 2006.1 |

| |Induction of labour should result in labour i.e., with adequate uterine contractions and progressive dilatation of the |

| |cervix, resulting in vaginal delivery of a viable pregnancy with minimal discomfort and risk to both mother and fetus. |

| |Various methods of induction are practiced as with medical and surgical methods, but the practice of induction is not |

| |consistent with different hospitals in the same country. Despite the advances in basic knowledge, we have not come far in |

| |providing the obstetrician with safe, reliable, and cost effective methods to induce labour. |

| |Hence the aim of this study is to know the pattern of induced labour and compare it with patterns of spontaneous labour, |

| |partographically, to derive at the best possible inducing agent. As oxytocin and prostaglandins are released during labour |

| |as a normal physiological process mimicking normal labour, we will attempt to study these agents in detail. |

| |Review of Literature |

| |Induction of labour is showing a rising trend. It is indicated in medical, obstetric and foetal conditions in which |

| |prolongation of pregnancy would jeoparadize maternal and foetal well being. Various methods of induction used in the past |

| |were stripping, rupture of membranes, massage of the uterus, massage of the breasts, sponge tents in cervix, extraamniotic |

| |injection of fluid, vaginal tampon, laminaria tents, etc. Methods commonly applied in the recent times for induction of |

| |labour are |

| |Medical methods – Oxytocin, prostaglandins |

| |Mechanical methods – Transcervical catheter, extramnionic saline infusion (EASI), hydroscopic cervical dilators, membrane |

| |stripping. |

| |Surgical method – Rupture of membranes. |

| |Fonesca et al, in 2008 conducted a randomized trial of preinduction cervical ripening with misoprostol V/s oxytocin in 336 |

| |women, where 168 women were induced with oxytocin and 168 women with 25 (g misoprostol, 4th hourly to a maximum of 3 doses,|

| |vaginally, until bishopscore of ( 7 or active labour achieved. They concluded that use of oxytocin alone decreases the |

| |induction delivery interval when compared to misoprostol. Misoprostol induction does not improve the vaginal delivery rate,|

| |but prolongs the time to delivery; cesearean delivery rate, maternal complications and neonatal outcomes were not |

| |significantly different.2 |

| |Luty et al conducted a cohort study in 2004 and compared spontaneous labour and elective induction for all term, singleton,|

| |cephalic, nulliparous gestations over 2 years and concluded that nulliparous women are at significant risk of cesarean |

| |delivery, if elective induction is performed. The individual physician has a contributing effect to this increased risk. 3 |

| |Stubblefield et al in 1995 conducted a RCT of vaginal misoprostol and intracervical PGE2 gel for induction of labour at |

| |term and conclucded that misoprostol is more effective than intracervical PGE2 in bringing about labour and delivery.10 |

| |Louis Sanchez et al conducted a randomized study of labour induction with intravaginal misoprostol in term PROM patients in|

| |1997 in 141 women; 70 women were induced with misoprostol and 71 women were induced with oxytocin infusion. They found that|

| |intravaginal misoprostol induces labour safely and effectively in patients with PROM. 4 |

| |Bennett et al in 1998conducted a marked randomized comparison of oral and vaginal administration of misoprostol for labour |

| |induction on 206 women. Labour was induced with oral dose of 50(g misoprostol orally and 50(g or misoprostol vaginally |

| |.They concluded that there is shorter interval of induction delivery with vaginal dose of misoprostol, and more incidence |

| |of tachysystole with oral dose of misoprostol. |

| |Objective of the Study: |

| |To study the cervimetric progress (pattern) of labour in women who had spontaneous labour and in those who had induced |

| |labour, in primigravida. |

| |To compare partographically the outcome of labour by various induction methods in terms of: |

| |Success rate |

| |Failure rate |

| |Maternal complications |

| |Foetal complications |

| |Induction-delivery interval |

| |Mode of delivery. |

| |and to suggest one nearer the best |

| | |

|7. |MATERIALS AND METHOD |

| |Source of Data |

| |Hospitals attached to J.J.M. Medical College namely : |

| |Bapuji Hospital, Davangere, |

| |Chigateri General Hospital, Davangere. |

| |Women and children Hospital, Davangere. |

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| |Duration of study – November 2010 to October 2012 |

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| |Method of collection of Data (including sampling procedures if any) |

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| |Design: Randomised control trial. |

| | |

| |Number of cases : 100 |

| | |

| |Inclusion criteria: |

| |Primigravida with singleton pregnancy with vertex presentation, either in the latent phase of spontaneous labour or having |

| |an indication for induction of labour as laid down in the ACOG practice bulletin 107, August 2009. 1 |

| |Abruptio placenta |

| |Chorioamnionitis |

| |Fetal demise |

| |Gestational HTN |

| |Preeclampsia, eclampsia |

| |Premature rupture of membranes |

| |Post-term pregnancy |

| | |

| | |

| |Maternal medical conditions- e.g., DM, renal disease,chronic pulmonary disease, antiphospholipid antibody syndrome |

| |Fetal compromise-eg, severe fetal growth retardation, isoimmunisation, oligohydrminos. |

| | |

| |Exclusion Criteria: |

| |Pregnant women having contraindication for induction of labour as laid down in the ACOG practice bulletin 107, Aug 2009. 1 |

| |Also those patient in whom there was a medical contraindication for oxytocin / prostaglandins. |

| |Vasa previa or complete placenta previa |

| |Transverse fetal lie |

| |Umbilical cord prolapse |

| |Previous classical cesarean delivery |

| |Active genital herpes infection |

| |Previous myomectomy entering the endometrial cavity. |

| | |

| |PROCEDURE OF STUDY: |

| |Patients are selected according to the inclusion criteria, and are divided at random into four equal groups. |

| |Labour induced with 25 (g oral prostaglandin (misoprostol) alone. |

| |Labour induced with 25(g vaginal prostaglandin (misoprostol) alone. |

| |Labour induction with IV oxytocin alone |

| |Latent phase of spontaneous labour. |

| |On admission to the labour room, the data is collected and clinical examination of patients based on a prepared |

| |questionnaire which also included the plotting of labour progression on a partogram(WHO). |

| |Induction with oral misoprostol is started with initial dose of 25 micrograms, repeated every 4th hourly until adequate |

| |contractions pattern set in (5 contractions or less in 10 min – averaged over a 30 min window), maximum allowable doses |

| |being 6. |

| |Induction with intra vaginal misoprstol with 25(g in posterior fornix, repeated every 4th hourly until adequate |

| |contractions / maximum allowable dose of 6. |

| |Induction with oxytocin will be done with high dose regimen i.e, starting with dose of 6 mu/min, followed by incremental |

| |increase in 3-6 mu/min at interval of 15-40 (min) untill adequate contractions set in . |

| |Cervical status is assessed by using modified Bishops score prior to induction and then after 6 hour of induction followed |

| |by every 2-3 hourly whenever clinically indicated. We will note for the time of various stages of labour, time from |

| |induction to delivery, route of delivery and failed induction. |

| | |

| |Does the Study require any investigations or interventions to be conducted on patients or other humans or animals? If so |

| |please describe briefly. |

| |Yes |

| |Investigations : Blood – Hb%, Blood grouping |

| |HIV I and II |

| |HBsAg |

| |Urine – albumin sugar |

| |Ultrasonography |

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

| |Yes |

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|8. |LIST OF REFERENCE |

| |American College of obstetrician and Gynecologists. Induction of labor. ACOG practice Bulletin 107, August 2009; 114(1): |

| |386-397. |

| | |

| |Fonesca L, Wood HC, Lucas MJ, Ramin SM, Phatak D, Gilsteap LC et al. Randomised trial of preinduction cervical ripening |

| |with misoprostol versus oxytocin. 3rd edn., Am J Obstet Gynecol 2008; 199(3): 305. |

| | |

| |Luthy DA, Malngren JA, Zingheim RW. Cesarean delivery after elective induction in nulliparous women : They physician |

| |effect. Am J Obstet Gynecol 2004; 191: 1511. |

| | |

| |Sanchez-Ramos L, Kaunitz AM, Chen AH, Gavdier FL, Delke I. Labour induction with intravaginal misoprostol in term premature|

| |rupture of membranes: a randomized study. Obstet Gynecol 1997; 89:909-12 (Level I). |

| | |

| |Danielsson KG, Marions L, Rodriiguez A, Spur BW, Wong PYK, Bygdeman M. Comparison between oral and vaginal administration |

| |of misoprostol on uterine contractility. Obstet Gynecol 1999; 93: 275-280. |

| | |

| |Zeiman M, Fong SK, Benowitz NL, Banskster D, Darney PP. Absorption kinetics of misoprostol with oral or vaginal |

| |administration. Obstet Gynecol 1997; 90: 88-92. |

| | |

| |Sanchez-Ramos L, Kaunitz AM, DeValle et al. Labour induction with PGE, Methyl analogue misoprostol versus oxytocin. A |

| |Randomised trial. Obstet Gynecol 1993; 81: 332-36. |

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| |Satin AJ, Leveno KJ, Sherman MC, Brewster DS, Cunningham FG. High-versus low dose oxytocin for labour stimulation. |

| |Obstet-Gynecol 1992;80:111-116. |

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| |Wing DA, Ham D, Paul R. A comparison of orally administered misoprostol with vaginally administered misoprostol for |

| |cervical ripening and labour induction. Am J Obstet Gynecol 1999; 180: 1155-1160. |

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| |Gregson S, Waterstone M, Noeman I, Murrells T. A randomized controlled trial comparing low dose vaginal misoprostol and |

| |dinoprostone vaginal gel for inducing labour at term. BJOG 2005; 112: 438-44(II). |

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| |Vrovenraets FP, Roumen FJ, Dehing CJ, van der Akker ES, Arts MJ, Scheve EJ. Bishop score and risk of cesarean delivery |

| |after induction of labour in nulliparous women. Obstet Gynecol 2005;105:690-7(11-2). |

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|9. |Signature of the Candidate | |

|10. |Remarks of the Guide | |

| | |Recommended and forwarded for study |

|11. |Name & Designation | |

| |Guide |Dr. MANJUNATH G H., M.D. |

| | |Professor |

| | |Department of Obstetrics and Gynecology |

| | |J.J.M. Medical College |

| | |Davangere – 577 004 |

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| |Signature | |

| | |Dr. VEENA G.R., M.D., |

| | |Professor |

| |Co-Guide (If any) |Department of Obstetrics and Gynecology |

| | |J.J.M. Medical College |

| | |Davangere – 577 004 |

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| |Signature | |

| | |Dr. B.R. DAKSHAYINI DEVARU, M.D.,D.G.O |

| | |Professor and Head |

| |Head of the Department |Department of Obstetrics and Gynecology |

| | |J.J.M. Medical College |

| | |Davangere – 577 004 |

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| |Signature | |

|12 |Remarks of the Chairman & the Principal | |

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| |Signature | |

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