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CTRI Number  CTRI/2025/08/092713 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to find out if giving Mifepristone before Prostaglandins helps start labour earlier than using Prostaglandins alone in full-term pregnant women. 
Scientific Title of Study   A Prospective, Parallel-group, Double Blinded Randomized Controlled Trial to Compare the Safety and Efficacy of Sequential Oral Mifepristone and Prostaglandins Versus Prostaglandins alone for Induction of Labor in women with Singleton Term Live Pregnancies 
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 Rinku Sengupta Dhar 
Designation  Chief and Senior Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Obstetrics and Gynaecology Holy Family Hospital Okhla Road New Delhi

South
DELHI
110025
India 
Phone  09810404057  
Fax    
Email  rinku.sengupta68@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arpita De 
Designation  Senior Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Obstetrics and Gynaecology Holy Family Hospital Okhla Road New Delhi

South
DELHI
110025
India 
Phone  09899864949  
Fax    
Email  arpitade07@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arpita De 
Designation  Senior Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Obstetrics and Gynaecology Holy Family Hospital Okhla Road New Delhi

South
DELHI
110025
India 
Phone  09899864949  
Fax    
Email  arpitade07@gmail.com  
 
Source of Monetary or Material Support  
Holy Family Hospital Okhla Road New Delhi-110025 India 
 
Primary Sponsor  
Name  Holy Family Hospital 
Address  Department of Obstetrics and Gynaecology Holy Family Hospital Okhla Road-110025 New Delhi India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rinku Sengupta Dhar  Holy Family Hospital  Room no 44 Department of Obstetrics & Gynecology Okhla Road New Delhi-110025 India
South
DELHI 		 09810404057

rinku.sengupta68@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Holy Family Hospital Institute Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Parallel group 1: Oral Mifepristone followed by Dinoprostone gel   Oral Mifepristone (200 mg, 2 doses 24 hours apart). After 12hours of 2nd Dose of Mifepristone. give Dinoprostone gel (Dose- 0.5 mg intracervical every 6 hours, maximum up to 3 doses). 
Comparator Agent  Parallel group 1: Placebo followed by Dinoprostone gel  Oral Placebo (Calcium Tablet), 500mg, 2 doses 24 hours apart on OPD basis. After 12 hours of 2nd dose give Dinoprostone gel (0.5 mg intracervical every 6 hours, up to 3 doses). 
Intervention  Parallel group 2: Mifeprostine followed by Misorprostol tablet  Oral Mifepristone (200 mg, 2 doses 24 hours apart) on OPD basis. After 12hours of 2nd dose of Mifepristone give Oral Misoprostol (25 mcg every 2 hours, up to 5 doses). 
Comparator Agent  Parallel group 2: Placebo followed by Misoprostol   Oral Calcium tablet (500 mg, 2 doses 24 hours apart) on OPD basis. After 12hours of 2nd dose of Mifepristone give Oral Misoprostol (25 mcg every 2 hours, up to 5 doses). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Singleton, term, live pregnancies with a cephalic presentation and a cervical Bishop score of less than 6 were included
2.Induction could be deferred for 48 hrs
3.Intact Membranes
4.Confirmed Gestational age of 37 weeks or more (term pregnancy)
5.Ability to provide informed consent
 
 
ExclusionCriteria 
Details  1.Any mother who needs more than one type of prostaglandins, i.e requiring both Dinoprostone gel and Misoprostol oral tablets.
2.Malpresentation
3.Previous Caesarean
4.Multiple Pregnancies
5.Placenta Previa
6.Intrauterine death of Fetus
7.Any mother who is not eligible for trial of vaginal delivery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of Induction to-onset of labour and Comparison of Induction to-delivery interval interval in the different groups

 		 1st, 2nd, 3rd year 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of improvement in Bishop scores at 48 hours in different groups  48 hours  
Comparison of modes of delivery in the different groups  5 days 
Comparison of duration of oxytocin augmentation in the different groups  5 days 
Rate of failed induction in the different groups  5 days 
To compare maternal morbidity in different groups   5 days 
To compare neonatal morbidity in different groups defined below  7 days 
 
Target Sample Size   Total Sample Size="208"
Sample Size from India="208" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/09/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This is a prospective, double-blinded, randomized controlled trial being conducted at Holy Family Hospital to evaluate the safety and effectiveness of oral Mifepristone given before Prostaglandins for induction of labour in women with singleton term pregnancies. The study includes two comparison groups based on the type of prostaglandin selected by the treating obstetrician: Dinoprostone gel or Misoprostol tablets. Each group is further randomized to receive either Mifepristone or a matching placebo, followed by the selected prostaglandin for labour induction.

Eligible pregnant women (18–40 years) with live, term singleton pregnancies and a Bishop score <6 will be enrolled. A total of 208 participants will be recruited. Mifepristone or placebo will be administered on an outpatient basis (two doses, 24 hours apart), followed by admission and administration of prostaglandins. Labour will be monitored and managed as per standard protocols. The primary outcome is the induction-to- onset of labour and induction to delivery interval, and secondary outcomes include mode of delivery, maternal and fetal outcomes, and adverse effects. The study will follow intention-to-treat analysis and is expected to be completed in 3 years.

 
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