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
|
|
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
|
|
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. |