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CTRI Number  CTRI/2023/07/055743 [Registered on: 26/07/2023] Trial Registered Prospectively
Last Modified On: 28/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of the efficacy of oral progestogens in the management of threatened miscarriage  
Scientific Title of Study   A randomized controlled trial comparing the efficacy of oral progestogens in the management of threatened miscarriage  
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 Bidisha Banerjee  
Designation  Post graduate trainee (Obstetrics and Gynaecology) 
Affiliation  Vivekananda institute of medical sciences  
Address  Ramakrishna mission seva pratishthan, Vivekananda institute of medical sciences, 99 Sarat Bose road, Kolkata

Kolkata
WEST BENGAL
700026
India 
Phone  8250431091  
Fax    
Email  banerjeebids@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sajal Datta  
Designation  Associate professor ( department of Obstetrics and Gynaecology) 
Affiliation  Vivekananda institute of medical sciences  
Address  Ramakrishna mission seva pratishthan, Vivekananda institute of medical sciences, 99 Sarat Bose road, Kolkata

Kolkata
WEST BENGAL
700026
India 
Phone  9830065242  
Fax    
Email  sajaldat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bidisha Banerjee  
Designation  Post graduate trainee (Obstetrics and Gynaecology) 
Affiliation  Vivekananda institute of medical sciences  
Address  Ramakrishna mission seva pratishthan, Vivekananda institute of medical sciences, 99 Sarat Bose road, Kolkata


WEST BENGAL
700026
India 
Phone  8250431091  
Fax    
Email  banerjeebids@gmail.com  
 
Source of Monetary or Material Support  
Vivekananda Institute of Medical Sciences, kolkata  
 
Primary Sponsor  
Name  Dr bidisha banerjee  
Address  Ramakrishna mission seva pratishthan, Vivekananda institute of medical sciences, 99 Sarat Bose road, Kolkata 700026 
Type of Sponsor  Other [Dr bidisha banerjee ] 
 
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 bidisha banerjee   Vivekananda institute of medical sciences, Ramakrishna mission seva pratishthan   Department of Obstetrics and Gynaecology, antenatal clinic -3 and post natal ward
Kolkata
WEST BENGAL 		 8250431091

banerjeebids@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of The Ramakrishna Mission Seva Pratishthan Vivekananda Institute of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral dydrogesterone   Oral dydrogesterone 10 mg- 40 mg stat followed by 10 mg at twice daily dosing starting from the period of detection of threatened miscarriage till upto 18 weeks of gestation  
Intervention  Oral micronized progesterone sustained release   Oral micronized progesterone sustained release 400 mg at once daily dosing starting from the period of detection of threatened miscarriage till upto 18 weeks of gestation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Period of gestation between 6-16 weeks presenting with threatened
miscarriage (with or without the history of 1/more abortion of
unknown etiology) confirmed by dating scan.
3. Confirmed intra uterine live pregnancy (by means of ultrasonography) 
 
ExclusionCriteria 
Details  Age of women older than 40 years,
IVF pregnancy
Multifoetal pregnancy
Pregnancy with any condition that can explain her present miscarriage 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Oral natural micronized progesterone sustained release is non inferior to
dydrogesterone in the management of threatened miscarriage in 121 antenatal patients 		 Till 28 weeks of gestation or the time of delivery (whether complete abortion or live birth) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of oral progestogens in threatened miscarriage.  From 28 weeks of period of gestation or upto the period of gestation at the time of delivery whether live birth or abortion 
 
Target Sample Size   Total Sample Size="121"
Sample Size from India="121" 
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/08/2023 
Date of Study Completion (India) 28/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/12/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-08-2023 and end date provided 01-08-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Threatened miscarriage is a fairly common complication in early 
pregnancy. Various studies have claimed the role of progesterone in management of threatened abortion. An oral sustained-release formulation of NMP (NMP-SR) has been developed which has a better tolerability profile and bioavailability than conventional oral NMP allowing for once-daily dosing. Also dydrogesterone allows
administration of lower dose and avoids progestogenic side effects. Based on these evidences we will take an attempt to compare the efficacy of the two preparations of progesterone in patients with threatened miscarriage.
 
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