CTRI Number |
CTRI/2018/08/015553 [Registered on: 31/08/2018] Trial Registered Retrospectively |
Last Modified On: |
27/08/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Comparing drug versus drug with catheter in low risk first time pregnant mothers for labor induction |
Scientific Title of Study
|
Misoprostol with Foleys catheter versus Misoprostol alone for induction of labor in term primigravidas - a prospective randomized coitrol trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Neeraj Kulkarni |
Designation |
Post Graduate |
Affiliation |
Christian Medical College |
Address |
Department of Obstetrics and Gynaecology unit - 3
Vellore TAMIL NADU 632004 India |
Phone |
9566804173 |
Fax |
|
Email |
drneerajkulkarni@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jessie Lionel |
Designation |
Professor |
Affiliation |
CMC Vellore |
Address |
Department of Obstetrics and Gynaecology Unit I
Christian Medical College
Vellore TAMIL NADU 632004 India |
Phone |
9566804173 |
Fax |
|
Email |
jessielionel@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Jessie Lionel |
Designation |
Professor |
Affiliation |
CMC Vellore |
Address |
Department of Obstetrics and Gynaecology unit I
Christian Medical College
Vellore TAMIL NADU 632004 India |
Phone |
9566804173 |
Fax |
9566804173 |
Email |
jessielionel@cmcvellore.ac.in |
|
Source of Monetary or Material Support
|
Department of Obstetrics and Gynaecology unit I Christian Medical College Vellore Tamil Nadu 632004 |
|
Primary Sponsor
|
Name |
CMC vellore |
Address |
CMC Vellore Tamil Nadu 632004 |
Type of Sponsor |
Research institution |
|
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 Jessie Lionel |
Christian Medical College |
Department of Obstetrics and Gynaecology unit I Vellore TAMIL NADU |
9566804173
jessielionel@cmcvellore.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Christian Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Pregnant women who are planned for induction of labor, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Misoprostol |
PV PGE1 Q4h for 3 doses |
Comparator Agent |
misoprostol with foleys |
Misoprostol versus misoprostol with foleys comparing term primi gravida whether interval to delivery is reduced |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
1 Primigravida
2 37 completed weeks to 40+6 weeks of gestation
3 Low risk pregnancy
4 Singleton, cephalic presentation, live fetes
5 Intact membranes
6 Bishops Score <6 (not in labour)
• Reactuve preinduction CTG |
|
ExclusionCriteria |
Details |
1 Multigravida
2 Bishops Score >6
3 High Risk Pregnancy
4 Rupture of membranes
5 Maternal fever
6 Non vertex presentation
7 Non reassuring CTG
8 Reinduction (previously unsuccessful induction of labour)
9 Allergy to Misoprostol/ latex
10 Previous LSCS/myomectomy |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Induction to delivery interval |
once |
|
Secondary Outcome
|
Outcome |
TimePoints |
Rate of vaginal delivery
Rate of primary LSCS
Incidence of Meconium stained liquor Uterine tachysystole with CTG changes Endomyometritis
Need for Terbutaline
Chorioamnionitis
Asphyxia (Cord pH , 7.2, low APGAR 5 and 7 )
Atonic PPH
NICU admission
Endomyometritis
|
All these outcomes will be assessed at the time of delivery and upto 6 weeks post partum |
|
Target Sample Size
|
Total Sample Size="608" Sample Size from India="608"
Final Enrollment numbers achieved (Total)= "589"
Final Enrollment numbers achieved (India)="589" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/09/2015 |
Date of Study Completion (India) |
02/04/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="3" Months="6" Days="2" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
not yet planned |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
In Christian Medical College, Vellore, incidence of induction of labour whenever indicated, is about 15- 20%. The rate of primary LSCS is about 18-24%, failed induction accounting for 6-10% of cases |