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CTRI Number  CTRI/2016/02/006637 [Registered on: 15/02/2016] Trial Registered Prospectively
Last Modified On: 20/09/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Is oral tablet misoprostol more effective and safer than injectible drug oxytocin in pregnant women at term whose membranes ruptured before the onset of labour pains. 
Scientific Title of Study   A randomized controlled unmasked trial comparing safety and efficacy of oral misoprostol with intravenous oxytocin for induction in prelabour rupture of membranes at term 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrShiny Nirupama Boddu  
Designation  PG Registrar 
Affiliation  Christian Medical College and Hospital 
Address  57, 3/6 X block , CMCH Vellore
Ida Scudder Road, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  7094910812  
Fax    
Email  nirupamashiny@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  DrJiji Mathews 
Designation  Professor 
Affiliation  Christian Medical College and Hospital 
Address  Dept of Obs and gyn, Christian Medical college and hospital, vellore
Ida Scudder Road, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162283387  
Fax    
Email  coronistrial@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DrJiji Mathews 
Designation  Professor 
Affiliation  Christian Medical College and Hospital 
Address  Dept of Obs and gyn, Christian Medical college and hospital, vellore
Ida Scudder Road, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162283387  
Fax    
Email  coronistrial@yahoo.co.in  
 
Source of Monetary or Material Support  
Internal Fluid Research, Christian Medical College and Hospital, Vellore 632004 Tamilnadu 
 
Primary Sponsor  
Name  Dept of Obstetrics and Gynaecology Christian Medical College and Hospital 
Address  Ida Scudder Raod Vellore 632004 Tamilnadu 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shiny Nirupama Boddu  Department of obstetrics and gynaecology  Christian Medical College and hospital, Vellore
Vellore
TAMIL NADU 
7094910812

nirupamashiny@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The institutional Review Board (silver,Research and Ethics Committee)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pregnant women at term with prelabour rupture of membranes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral misoprostol  Intravenous oxytocin induction 
Comparator Agent  oral misoprostol with intravenous oxytocin  Comparing safety and efficacy of 50mcg of oral misoprostol with intravenous oxytocin in antenatal women at term in premature rupture of membranes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  • Pregnancies between 37 – 41 weeks of gestation with singleton foetus with vertex presentation
• Reassuring fetal heart rate
• Definite diagnosis of PROM
 
 
ExclusionCriteria 
Details  -Contraindications to vaginal delivery
-Previous uterine scar
-Diagnosis of labour
-Meconium stained liquor
-Clinical estimated fetal weight > 4 kgs
-Evidence of chorioamnionitis, temperature > 100.4 degree Fahrenheit, uterine tenderness or foul smelling amniotic fluid.
-Any severe medical disease like diabetes on insulin or severe pre-eclampsia
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
-Duration between induction and delivery
-Vaginal delivery achieved within 24 hours
-Caesarean section
 
Difference of 2 hours from induction to delivery. 5% difference in LSCS rates 
 
Secondary Outcome  
Outcome  TimePoints 
-Need for oxytocin augmentation -Serious neonatal morbidity or perinatal death eg sepsis,seizures,birth asphyxia,neonatal encephalopathy-Serious maternal morbidity or death eg sepsis,admission to ICU,septicaemia,traumatic PPH-Fever, chorioamnionitis, endometritis-Apgar score less than seven at five minutes-Neonatal intensive care unit admission-Maternal nausea-Maternal diarrhea-Other maternal side-effects-PPH more than500ml of blood loss -Woman and Caregiver not satisfied  Soon after delivery. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/02/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   planning to publish 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
              This is a prospective  randomized controlled unmasked trial which will be done in pregnant women at term  with pre-labour rupture of membranes. Active or planned management in pre-labour rupture of membranes redues maternal infectious morbidity and   neonatal care unit admission  when compared to  expectant management [1]. There are different methods of induction of labour for pre-labour rupture of membranes. In this study we are comparing oral misoprostol to intravenous oxytocin for induction of labour.  Research done in this institution [2] on term inductions without rupture of membranes has shown that women in the group that received oral misoprostol were more likely to develop uterine contractions without oxytocin than women given vaginal  misoprostol. Thus due to ease of administration especially in women with rupture of membranes ,we deciced to use oral misopostol. Women in the arm randomized to oxytocin will be induced with usual oxytocin protocol followed in labour room for induction of labour. Women randomized to oral misoprostol will be given oral misoprostol 50mcg at four hourly inteval maximum of three doses in primi gravida and two doses in multi gravida.These women then be induced with oxytocin after twelve hours of first dose of oral misoprostol if they do not have uterine contractions.After informed consent, women will be recruited from labour room and randomized to either of the groups. Data regarding duration of labour, fever ,CTG abnormalities, neonatal morbidity etc, will be collected. The data collected will be  analysed to compare safety  and efficacy in both groups.
  BIBLIOGRAPHY:
1.Dare MR, Middleton P, Crowther CA, Flendy FJ, Varatharaju B. Planned early birth vresus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more).Cochrane Database Syst rev  2006 jan 25;(1):CD005302.
2. A radomized double mask placebo controlled  trial comparing oral misoprostol with vaginal misoprostol for induction of labour. Dr.HIlda Yenuberi, Dr.Anuja Abraham, Dr.Ajit Sabastian, Dr.SAnthosh Joseph Benjamin,Dr.Visalakshi Jayasheelan, Dr.Jiji Elizebeth Mathew Awaiting Publication. 
 
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