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CTRI Number  CTRI/2025/08/092685 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Transcervical Foley Catheter with or without Single Dose Oral Mifepristone in Women with Previous cesarean section on success of Vaginal Delivery  
Scientific Title of Study   Comparison of Efficacy of Transcervical Foley Catheter with or without Single Dose Oral Mifepris-tone on Vaginal Delivery Among Women Undergoing the Trial of Labour After Caesarean Section at Term –A Randomised, Double-blinded, Placebo-Controlled 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 Sumayya begum 
Designation  Junior resident obstetric and gynecology jipmer 
Affiliation  Jawaharal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Old blackwell hostel JIPMER campus Gorimedu Dhanvantarinagar Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9538591893  
Fax    
Email  sumayyasumayyabegum123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrT Parvathi 
Designation  Associate Professor Obstetric and Gynaecology jipmer 
Affiliation  Jawaharal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  1st Floor ICMR RESEARCH lab Department of Obstetrics and Gynaecology Women and Children Hospital JIPMER, Dhanvantarinagar

Pondicherry
PONDICHERRY
605006
India 
Phone  9566537193  
Fax    
Email  Jd1232@jipmer.ac.in  
 
Details of Contact Person
Public Query  
Name  DrT Parvathi 
Designation  Associate Professor Obstetric and Gynaecology jipmer 
Affiliation  Jawaharal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  1st Floor ICMR RESEARCH lab Department of Obstetrics and Gynaecology Women and Children Hospital JIPMER, Dhanvantarinagar

Pondicherry
PONDICHERRY
605006
India 
Phone  9566537193  
Fax    
Email  Jd1232@jipmer.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  JIPMER INTRAMURAL 
Address  JIPMER Dhanvantari nagar Puducherry 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 T Parvathi   Women and Children Hospital, JIPMER  Labour room, Ground floor, Women and Childrens Hospital, JIPMER, Dhanvanthri Nagar
Pondicherry
PONDICHERRY 		 09566537193

jd1232@jipmer.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women with previous LSCS planned for Induction of labour 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Transcervical Foley Catheter 22Fr for 24 hours with a placebo orally for induction of labour in Womwn undergoing TOLAC  Placebo Orally will be given Under sterile Aseptic precautions 22Fr foley catheter will be inserted Intracervically the balloon will be inflated initially with 5ml of normal saline and will be gently retracted till resistance is felt over the internal os and will be further inflated with 55ml of normal salin for the duration of 24 hours and Bishops score will be assessed whenever the foley is expelled, and the duration of the foley in situ will be noted. If foley is not expelled within 24 hours, then the balloon is deflated and removed, and Bishop score will be assessed. 
Intervention  Transcervical Foley catheter 22Fr for 24 hours with a Single dose of oral Mifepristone 200mg for induction of labour in Women undergoing TOLAC  Tab. Mifepristone 200 mg single dose orally will be given. Under sterile Aseptic precautions 22Fr foley catheter will be inserted Intracervically the balloon will be inflated initially with 5ml of normal saline and will be gently retracted till resistance is felt over the internal os and will be further inflated with 55ml of normal salin for the duration of 24 hours and Bishops score will be assessed whenever the foley is expelled, and the duration of the foley in situ will be noted If foley is not expelled within 24 hours, then the balloon is deflated and removed, and Bishop score will be assessed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Age more than or equal to 18 years
2. Period of gestation: 370/7 – 42 weeks
3. Singleton live fetus in cephalic presentation with intact membranes
4. Reactive Non-Stress Test (NST)
5. Bishop score less than or equal to 4
6. Eligible for trial of labour after caesarean section (TOLAC) 
 
ExclusionCriteria 
Details  1. Requiring imminent delivery
2. With known contraindications/hypersensitivity to Mifepristone
3. Major fetal anomalies
4. Absolute contraindication for TOLAC
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Vaginal birth after caesarean rate (VBAC)  At 24 hours
At 48 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Bishop score  at 24 hours of intervention or
at expulsion of foley catheter or rupture of membranes,
whichever is earlier 
Need for induction/augmentation with oxytocin (dose/duration)  at 24 hours of intervention or
at expulsion of foley catheter or rupture of membranes,
whichever is earlier till delivery of the baby 
Duration of foley-in-situ  at 24 hours of intervention or
at expulsion of foley catheter or rupture of membranes,
whichever is earlier 
Induction to delivery interval (IDI)  Induction of labour with intervention to delivery of the baby 
Maternal & Perinatal outcome  at 24 hours of intervention
at delivery of the baby
at discharge from the hospital 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   01/10/2025 
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="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  on request mail to Guide (jd1232@jipmer.ac.in)

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 30-09-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This is a prospective randomised controlled trial comparing the use of mifepristone plus Foley catheter vs Foley catheter alone for labour induction in women with a history of one prior LSCS. It evaluates efficacy, safety, maternal and neonatal outcomes.There is a paucity of data comparing the efficacy of Foley catheters with or without mifepristone as an induction agent in women planned for TOLAC. In women with previous LSCS, IOL is limited to mechanical methods using a foley catheter or hygroscopic agents like laminaria tents or dilapan.  Mifepristone, as a single agent, has been used as an induction agent in women with previous LSCS A combination of these two methods would be more efficacious in reducing the use of uterotonic agents and induction delivery interval thereby increasing VBAC rate and decreasing the risk of scar dehiscence and rupture.

 
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