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CTRI Number  CTRI/2025/08/092551 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [comparison between sequential and concurrent use of oral misoprostol and foleys ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomized controlled trial comparing concurrent and sequential methods using Oral Misoprostol and Foleys Catheter. 
Scientific Title of Study   Induction of labour-An enigma,Concurrent versus sequential use of oral misoprostol plus foleys catheter for induction of labour. 
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 Preetha George 
Designation  Professor 
Affiliation  Malankara Orthodox Syrian Church Medical College 
Address  Department of Obstetrics and Gynaecology Room no 9

Ernakulam
KERALA
682311
India 
Phone  9447987840  
Fax    
Email  drpreetha69@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preetha George 
Designation  Professor 
Affiliation  Malankara Orthodox Syrian Church Medical College 
Address  Department of obstetrics and Gynaecology. Unit 2 Room No 9
KOOTTALIL HOUSE KUNNACKAL P O MUVATTUPUZHA ERNAKULAM
Ernakulam
KERALA
682311
India 
Phone  9447987840  
Fax    
Email  drpreetha69@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Preetha George 
Designation  Professor 
Affiliation  Malankara Orthodox Syrian Church Medical College 
Address  Department of Obstetrics and Gynaecology. Unit 2

Ernakulam
KERALA
682311
India 
Phone  9447987840  
Fax    
Email  drpreetha69@gmail.com  
 
Source of Monetary or Material Support  
Malankara Orthodox Syrian Church Medical College, Kolenchery 
 
Primary Sponsor  
Name  Malankara Orthodox Syrian Church Medical College 
Address  Malankara Orthodox Syrian Church Medical College Kolenchery p.o, 682311 Ernakulam 
Type of Sponsor  Private medical college 
 
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 Ann Mariam Abraham  Malankara Orthodox Syrian Church Medical College,  Department of Obstetrics and Gynaecology, Room no 10
Ernakulam
KERALA 
9778211902

annmariam02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Malankara Orthodox Syrian Church Medical College, Kolenchery  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Induction of labour using concurrent foleys catheter and oral misoprostol.  Clinical and demographic data is recorded. Favourability of cervix assessed with modified bishop’s score. For the concurrent group, foley’s catheter and oral misoprostol administration done on the same day  
Comparator Agent  Induction of labour using sequential foleys catheter and oral misoprostol.  Clinical and demographic data is recorded. Favourability of cervix assessed with modified bishop’s score. For the sequential group, foley’s catheter is introduced in the first day and oral misoprostol administration done on the next day. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  primigravida, full term singleton pregnancy, cephalic presentation ,intact membranes, reactive NST, modified bishop’s score less than 6,no other complications. 
 
ExclusionCriteria 
Details  previous uterine scar, rupture of membranes, placenta previa , intrauterine foetal death, latex allergy, presence of contraindications to vaginal delivery.  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
comparison of induction to delivery time interval between two groups

 
baseline and 1 week, 6 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
Vaginal delivery within 24 hours
 
1 week 
Number of doses needed to induce labour
 
1 week 
Need of oxytocin for augmentation of labour
 
1 week 
Cesarean section rate
 
1 week 
Maternal complications-Post partum pyrexia, Postpartum hemorrhage.
 
6 weeks 
Neonatal complications-APGAR score, Admission in NICU, Meconium stained amniotic fluid.
 
1 week 
Abnormalities in uterine contractility like uterine hypertonus, uterine tachysystole, uterine hyperstimulation
 
1 week 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   25/08/2025 
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="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  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 [annmariam02@gmail.com].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 02-02-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Induction of labour is a widely used obstetric intervention, occurring in one in four pregnancies. When the cervix is unfavorable, different induction methods are used. Recently with steadily increasing  rates of induction , implementing effective and safe procedures at proper gestation of pregnancy can significantly decrease maternal and foetal complications. Different mechanical and medical methods are used to induce labour, but all of the existing methods are associated with medical risks. Therefore, while choosing labour induction  method, numerous aspects like cost effectiveness, safety, and rate of operative delivery should be considered. An informed consent will be taken. Consenting eligible women are enrolled in the study and randomized to either concurrent or sequential use of oral misoprostol and foley’s catheter. Clinical and demographic data is recorded. Favourability of cervix assessed with modified bishop’s score. For the concurrent group, foley’s catheter and oral misoprostol administration done on the same day . For the sequential group, foley’s catheter is introduced in the first day and oral misoprostol administration done on the next day. We compare primary outcome which is Induction to delivery interval and secondary outcomes such as vaginal delivery within 24 hours, number of doses needed to induce labour, need of oxytocin for augmentation of labour, caesarean section rate, maternal complications, neonatal complications and abnormalities in uterine contractility

 
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