| 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 |