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CTRI Number  CTRI/2021/07/034943 [Registered on: 16/07/2021] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare Oral Mifepristone with Foley catheter for softening of cervix in women planned for delivery at or after 39 weeks of pregnancy 
Scientific Title of Study   Comparison of efficacy of single-dose Oral Mifepristone with Transcervical Foley catheter for pre-induction cervical ripening in singleton term and late-term pregnancy - An Open-label Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Y Jane Jasmine 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Obstetrics and Gynaecology Women and Children hospital JIPMER Pondicherry
Room number- 208 Old Blackwell House JIPMER Pondicherry
Pondicherry
PONDICHERRY
605006
India 
Phone  9787423967  
Fax    
Email  jasmine7jane@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  T Parvathi 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Obstetrics and Gynaecology JIPMER Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9566537193  
Fax    
Email  parvathinaik1@gmail.com  
 
Details of Contact Person
Public Query  
Name  T Parvathi 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Obstetrics and Gynaecology JIPMER Pondicherry


PONDICHERRY
605006
India 
Phone  9566537193  
Fax    
Email  parvathinaik1@gmail.com  
 
Source of Monetary or Material Support  
Intramural fund - Open tender or Limited tender JIPMER Puducherry 
 
Primary Sponsor  
Name  JIPMER INTRAMURAL 
Address  JIPMER DHANVANTARI NAGAR PUDUCHERRY 
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  JIPMER  Department of Obstetrics and Gynaecology Women and Children Hospital
Pondicherry
PONDICHERRY 		 9566537193

parvathinaik1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tablet Mifepristone  Tablet Mifepristone 400 mg orally will be given after examining the patient. Bishop score will be reassessed after 24 hours and 48 hours  
Comparator Agent  Transcervical Foley catheter 22 French  Under aseptic precautions, 22F Foley’s catheter will be introduced trans-cervically by using a sponge holder. After passing the catheter through internal os, the balloon will be inflated initially with 5ml normal saline and pulled over internal os and will be further inflated with 55ml of normal saline and the external end of the catheter will be taped to the medial aspect of maternal thigh with traction. Foleys catheter will be removed after 24 hours and Bishops score will be assessed at 24 hours, 48 hours or following spontaneous expulsion of Foley catheter 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Age ≥ 18 years
2. Period of gestation: 39 to 42 weeks
3. Singleton live fetus with cephalic presentation with reactive Non-stress Test
4. Bishop’s score ≤6
5. Intact membranes
6. Planned for induction of labour
7. Unscarred uterus  
 
ExclusionCriteria 
Details  1.Absolute contraindications for vaginal delivery
2.Patient requiring imminent delivery
3. Evidence of chorioamnionitis
4.Patients with known contraindications to Mifepristone 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine and compare the change in Bishop score with oral Mifepristone versus trans-cervical Foley catheter in women with singleton term and late term pregnancy undergoing pre-induction cervical ripening  Bishop score will be reassessed at 24 hours and 48 hours after administration of Tablet Mifepristone 
 
Secondary Outcome  
Outcome  TimePoints 
To determine and compare the efficacy and safety of oral Mifepristone with trans-cervical Foley catheter in women with singleton term and late term pregnancy undergoing pre-induction cervical ripening
 		 From administration of Mifepristone and Transcervical Foley catheter insertion to delivery of the baby 
 
Target Sample Size   Total Sample Size="266"
Sample Size from India="266" 
Final Enrollment numbers achieved (Total)= "266"
Final Enrollment numbers achieved (India)="266" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/07/2021 
Date of Study Completion (India) 31/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Plan to publish in an indexed journal after final analysis  
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 - Proposals should be directed to [jasmine7jane@gmail.com].

  6. For how long will this data be available start date provided 01-08-2021 and end date provided 01-07-2026?
    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  

Induction of labour is the most common obstetric procedure performed worldwide with an incidence of 25%.Success of labour induction depends on cervical “ripeness” or “favorability”. 

 Various pharmacological and mechanical methods are available for cervical ripening and induction of labor. Prostaglandin analogues like Dinoprostone(PGE2) and Misoprostol (PGE1) in various formulations are found to be more effective than Oxytocin,but are associated with the risk of uterine hyperstimulation, fetal distress and uterine rupture. Mechanical methods such asFoleycatheter and hygroscopic dilators are associated with decreased risk of uterine hyperstimulation but increased maternal and neonatal infectious morbidity.

Progesterone antagonist like Mifepristone has been extensively used for termination of pregnancy in 1st and 2nd trimester and term intrauterine fetal demise. It binds to progesterone receptor and blocks the action of progesterone at the cellular level thereby decreasing the myometrial quiescence state and increasing its sensitivity to uterotonic agents.

Several studies have shown that Mifepristone is a safe and effective way to ripen the cervix thereby inducing the labour process in term pregnancies with no adverse maternal or fetal events.There are no studies comparing the efficacy of Mifepristone with trans-cervical Foley catheter for pre-induction cervical ripening in term and late term pregnancy.

 If this study results show better or comparable effect of Mifepristone as pre-induction ripening agent to Foley catheter, then it can be used in outpatient basis for cervical ripeningthereby decreasing hospital stay with less infectious morbidity.

 
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