| CTRI Number |
CTRI/2014/02/004402 [Registered on: 13/02/2014] Trial Registered Retrospectively |
| Last Modified On: |
10/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing the use of oral labour inducing agent with vaginal agent |
|
Scientific Title of Study
|
Oral versus Vaginal misoprostol for induction of labour |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJiji Mathews |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Head of Obstetrics and Gynaecology Unit 5
Christian Medical College and Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283387 |
| Fax |
|
| Email |
coronistrial@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHilda Yenuberi |
| Designation |
PG Student |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Obstetrics and Gynaecology Unit 5
Christian Medical College and Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283387 |
| Fax |
|
| Email |
hildagrace@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJiji Mathews |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Head of Obstetrics and Gynaecology Unit 5
Christian Medical College and Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283387 |
| Fax |
|
| Email |
coronistrial@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Fluid Research Fund. Christian Medical College and Hospital, Vellore |
|
|
Primary Sponsor
|
| Name |
Christian Medical College and Hospital Vellore |
| Address |
Ida Scudder Road,
Vellore 632004,
Tamilnadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jiji Mathews |
Department of Obstetrics and Gynaecology |
Christian Medical College and Hospital,
Vellore 632004
Vellore
TAMIL NADU |
04162283387
coronistrial@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College and Hospital, Vellore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral misoprostol |
The oral drug included 50 mcg of misoprostol in the first dose, and 100 mcg drugs in both the second and the third dose. The doses were given at 4th hourly intervals. |
| Comparator Agent |
Vaginal misoprostol |
The vaginal drug included 25 mcg of the drug at 4th hourly intervals with a total of three doses. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnancies between 37 to 42 weeks of gestation admitted for labor induction with live, singleton fetus
Cephalic presentation
Bishop score less than 6
Reassuring fetal heart rate
Intact membranes
|
|
| ExclusionCriteria |
| Details |
Non-reassuring fetal heart rate
Contraindications to vaginal delivery
Previous uterine scar
Bishops score more than or equal to 7
Ruptured membranes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Vaginal delivery not achieved within 24 hours
2. Uterine hyperstimulation with fetal heart rate (FHR) changes
3. Caesarean section
|
1. Vaginal delivery not achieved within 24 hours
2. Uterine hyperstimulation with fetal heart rate (FHR) changes
3. Caesarean section
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measures of effectiveness
Cervix Unfavourable unchanged after 12 hours
Need for oxytocin augmentation
Complications
Serious neonatal morbidity or perinatal death
Serious maternal morbidity or death
Apgar score less than seven at five minutes
Neonatal intensive care unit admission
Maternal nausea vomiting
diarrhoea Other maternal side-effects
Postpartum haemorrhage more than 500ml of blood loss
Measures of satisfaction
woman or caregiver not satisfied |
Measures of effectiveness
Cervix Unfavourable unchanged after 12 hours
Need for oxytocin augmentation
Complications
Serious neonatal morbidity or perinatal death
Serious maternal morbidity or death
Apgar score less than seven at five minutes
Neonatal intensive care unit admission
Maternal nausea vomiting
diarrhoea Other maternal side-effects
Postpartum haemorrhage more than 500ml of blood loss
Measures of satisfaction
woman or caregiver not satisfied |
|
|
Target Sample Size
|
Total Sample Size="788"
Sample Size from India="788"
Final Enrollment numbers achieved (Total)= "778"
Final Enrollment numbers achieved (India)="778" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Trop Doct. 2016 Oct;46(4):198-205. Epub 2016 Jan 19.
A randomised double-blind placebo-controlled trial comparing stepwise oral misoprostol with vaginal misoprostol for induction of labour |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Induction of labour is considered beneficial in many circumstances. Cervical status is an important clinical factor which determines the outcome of induction process. More than 15 % of all gravid women require aid in cervical ripening. The main problems during induction of labour range from inability to achieve effective labour to excessively strong uterine contractions. Misoprostol a synthetic prostaglandin E1 analogue has been proposed as an alternative agent to Dinoprostone- agent of choice, for pre-induction cervical ripening. The recommended dose for vaginal route is 25 mcg every 4 hours. Excessive uterine contractions leading to fetal distress with these doses are still a cause of concern. Oral dose is known to be safer than vaginal route (1) probably because of its pharmacokinetics (2). In the WHO recommendation for Induction of labour,(3) the dosage of oral misoprostol was considered a research priority. Dodd et al showed that 25mg of misoprostol was ineffective (4).
Oral administration is easier and has greater acceptability among women. Absorption by oral route is rapid and peak serum concentration is reached in 34 minutes with a half-life of 20-40 minutes. Peak serum concentration for vaginal route is 60-80 minutes and effect lasts for 4 hours. Some studies have shown a short induction delivery interval with titrated doses of oral misoprostol (5,6,7).
The aim of this randomized controlled trial is to compare the safety and efficacy of titrated oral misoprostol with vaginal misoprostol for labour induction.
BIBILOGRAPHY:
1. Oral Misoprostol for induction of labour. Zarko Alfirevic, Andrew Weeks. Copyright 2010. The Cochrane Collaboration. Published by John Wiley & Sons, Ltd., .
2. Zieman M, Fong S, Benowitz N, Darney P. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol 1997;90:88-92
3. WHO Recommendations for Induction of Labour, 2011
4. Jodie M Dodd et al. Oral misoprostol for induction of labour at term : randomized controlled trial. BMJ 332:509 Published 2nd February, 2006.
5. Titrated oral misoprostol solution for induction of labour: a multi-centre, randomized trial. G.J.Hofmeyr, Z Alfirevic et al. British Journal of Obstetrics and Gynaecology, September 2001, Vol.108, pp.952-959
6. Titrated Oral Compared With Vaginal Misoprostol for Labor Induction. A Randomized Controlled Trial. Shi-Yann Cheng et al. The American College of Obstetricians and Gynecologists. VOL 111, NO.1, January 2008
7. Prospective randomized clinical trial of inpatient cervical ripening with stepwise oral misoprostol vs vaginal misoprostol. Iris Colon et al. American Journal of Obstetrics and Gynecology (2005) 192, 747-52 |