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CTRI Number  CTRI/2023/06/053401 [Registered on: 01/06/2023] Trial Registered Prospectively
Last Modified On: 17/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the effectiveness of 2 cervical ripening agents Oral Mifepristone and vaginal Isosorbide Mononitrate (IMN) for induction of labor in pregnant women with gestational age 28 to 34 weeks. 
Scientific Title of Study   A Comparative study to determine effectiveness of Mifepristone and Isosorbide Mononitrate(IMN) as cervical ripening agents for induction of labor in pregnant women with gestational age 28 to 34 weeks. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meeta Pandit 
Designation  Resident Surgical Officer/MS ObsGyn student  
Affiliation  MGM Medical College Indore 
Address  Department of Obstetrics and Gynaecology MTH Hospital and MGM Medical College Indore

Indore
MADHYA PRADESH
452001
India 
Phone  9827654118  
Fax    
Email  meetapandit26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Professor Anupama Dave  
Designation  Professor and Guide 
Affiliation  MGM Medical College Indore  
Address  Department of Obstetrics and Gynaecology MTH Hospital and MGM Medical College Indore

Indore
MADHYA PRADESH
452001
India 
Phone  9425053230  
Fax    
Email  anupamadave10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Professor Anupama Dave  
Designation  Professor and Guide 
Affiliation  MGM Medical College Indore  
Address  Department of Obstetrics and Gynaecology MTH Hospital and MGM Medical College Indore

Indore
MADHYA PRADESH
452001
India 
Phone  9425053230  
Fax    
Email  anupamadave10@gmail.com  
 
Source of Monetary or Material Support  
Department of Obstetrics and Gynaecology,MTH Hospital,siyaganj, Indore MP 
 
Primary Sponsor  
Name  Dr Meeta Pandit 
Address  MTH Hospital and MGM Medical College Indore 
Type of Sponsor  Other [Principal Investigator/self] 
 
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 Meeta Pandit   MGM Medical College and M Y Hospital  Department of Obstetrics and Gynaecology,MTH Hospital, MGM Medical College and M Y Hospital Siyaganj Indore MP
Indore
MADHYA PRADESH 		 9827654118

meetapandit26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics and Scientific Review Committee M.G.M. Medical College and M.Y. Hospital ,Indore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women with 28 to 34 weeks gestational age who need termination of pregnancy 
Patients  (1) ICD-10 Condition: O619||Failed induction of labor, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Oral tab. Mifepristone  200mg oral tab. Mifepristone single dose,oral route 
Intervention  vaginal Isosorbide Mononitrate IMN  40mg vaginal Isosorbide Mononitrate IMN,2doses at 6hrs interval, per vaginal route 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1.All 28 to 34 weeks pregnancy who need Induction of labor for obstetrics and maternal indications.
2.Bishops score less than 4.
3.Those giving consent.
 
 
ExclusionCriteria 
Details  1.Contraindications to vaginal birth.
2.Hypersensitivity to Mifepristone and IMN.
3.Contraindications to Mifepristone and IMN.
4.Those not giving consent. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Bishops Score
Duration between administration of cervical ripening agents and delivery
Failed induction is after 2 doses of misoprostol 3hrs apart
 		 at baseline
after 6hrs
after 12hrs
at 15 hrs
at 18 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Mode of delivery  Failed induction is after 2 doses of misoprostol 3h apart 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   09/06/2023 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [meetapandit26@gmail.com].

  6. For how long will this data be available start date provided 06-06-2024 and end date provided 06-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized control open label parallel group trial comparing the effectiveness of oral Mifepristone and vaginal Isosorbide Mononitrate IMN as cervical ripening agents for induction of labor in pregnant women of gestational age 28 to 34 weeks,for 12months in 100 pregnant women who need induction of labor for various obstetric and maternal indications, conducted at one center in India. The outcome will be assessed based on improvement in Bishops Score and  duration between administration of cervical ripening agent and delivery. 
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