| CTRI Number |
CTRI/2026/01/100980 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see if a tablet(Mifepristone)helps prepare the birth canal for easier labour in pregnant women reaching their full term. |
|
Scientific Title of Study
|
Assessing the efficacy of mifepristone in improving the preinduction cervical ripening at term gestation in a tertiary health centre : a double blind , randomized , placebo-control superiority trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nirmal Kanwar |
| Designation |
Post graduate resident |
| Affiliation |
RNT Medical College |
| Address |
Obstetrics and Gynaecology Department
RNT Medical College
Udaipur
RAJASTHAN
313004
India |
| Phone |
7014761838 |
| Fax |
|
| Email |
nirmalkanwar790@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Gandhi |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College |
| Address |
Obstetrics and Gynaecology department
RNT Medical College
Udaipur
RAJASTHAN
313004
India |
| Phone |
7014761838 |
| Fax |
|
| Email |
gandhisudha70@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirmal Kanwar |
| Designation |
Post graduate resident |
| Affiliation |
RNT Medical College |
| Address |
Obstetrics and Gynaecology department
RNT Medical College
Udaipur
RAJASTHAN
313004
India |
| Phone |
7014761838 |
| Fax |
|
| Email |
nirmalkanwar790@gmail.com |
|
|
Source of Monetary or Material Support
|
| Obstetric and Gynaecology Department ,RNT Medical College ,Court Chowk Udaipur,Rajasthan Pincode:313001 |
|
Primary Sponsor
Modification(s)
|
| Name |
RNT Medical College |
| Address |
Court Chowk , Udaipur , Rajasthan 313001 |
| Type of Sponsor |
Government 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 Nirmal Kanwar |
RNT Medical College |
Obstetrics and Gynaecology Department
Udaipur
RAJASTHAN |
07014761838
nirmalkanwar790@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee,R.N.T Medical College ,Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O610||Failed medical induction of labor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug-Mifepristone |
Dosage- 200mg po
Route - oral
Frequency - single dose
Timing - administered at term gestation for preinduction cervical ripening |
| Comparator Agent |
Placebo |
Similar looking multivitamin dummy pill |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Women aged 18 to 35 years undergoing labour with singleton pregnancy Period of gestation between 37 to 42 weeks in cephalic presentation and labor induction is indicated in next 24 to 48 hours.
2.Reactive Fetal heart rate & BISHOP score less than 6.
|
|
| ExclusionCriteria |
| Details |
1.Two or more previous Caesearn Sections or classical Caesearn section.
2.Gynaecological interventions such as myomectomy, Manchester repair or perineorrhaphy
3.Suspected abruption of placenta or radiological evidence of low lying placenta
4.Any obstetric contraindication to labour induction and obstetrics emergencies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the difference in fetal APGAR score and birth weight in intervention and control group. |
Baseline,24 hours and 48 hours post delivery in intervention and control group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence rate of cesarean section in intervention & control group.
|
To be compare for 1 year or till the total sample size reach. |
| To estimate the difference in time to normal vaginal delivery following intervention |
Time taken from intervention till the baby delivery. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2026 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Induction of labor is a common obstetric procedure when the benefits of delivery outweigh the risks of continuing the pregnancy. An unfavorable cervix is a major predictor of failed induction. Mifepristone, an anti progesterone, has been proposed as an effective agent for preinduction cervical ripening. Objectives :To assess the efficacy of oral Mifepristone in improving preinduction cervical ripening at term gestation and its impact on the mode of delivery. Methodology :This is a double blind, randomized, placebo controlled superiority trial involving 140 pregnant women at term gestation with an unfavorable cervix (Bishop score less than 6). Participants will be randomized to receive either a single oral dose of 200mg Mifepristone or an identical looking placebo. Outcomes : The primary outcomes include the change in Bishop score, the incidence of Cesarean section, and the time interval from induction to vaginal delivery. Maternal and neonatal safety profiles will also be monitored. |