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CTRI Number  CTRI/2025/08/093804 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 27/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   complications of self managed abortions 
Scientific Title of Study   Clincical outcome of self managed abortions reporting to tertiary level hospital 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Renuka Malik 
Designation  professor and principal consultant 
Affiliation  ABVIMS and Dr RML Hospital.New Delhi 
Address  department of OB-GYN ABVIMS&DR RML Hospital

New Delhi
DELHI
110001
India 
Phone  09871867700  
Fax    
Email  renucam@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Renuka Malik 
Designation  professor and principal consultant 
Affiliation  ABVIMS and Dr RML Hospital.New Delhi 
Address  2Dr (Prof) Renuka Malik Department of OB-GYN ABVIMS&DR RML Hospital, New Delhi

New Delhi
DELHI
110001
India 
Phone  09871867700  
Fax    
Email  renucam@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  preeti sania 
Designation  CMO,NFSG 
Affiliation  ABVIMS and Dr RML Hospital 
Address  Dr Preeti Sania CMO, Department of OB-GYN ABVIMS and DR RML Hospital, New Delhi

New Delhi
DELHI
110001
India 
Phone  9212719117  
Fax    
Email  preeti.sania@yahoo.com  
 
Source of Monetary or Material Support  
ABVIMS &DR RML Hospital, New Delhi 
 
Primary Sponsor  
Name  ABVIMS AND DR RML HOSPITAL 
Address  Baba kharak singh marg,New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Renuka Malik  department of family planning ,ABVIMS  Baba kharak singh marg,new delhi
New Delhi
DELHI 		 9871867700

renucam@yahoo.co.in 
Renuka Malik  Department of OB-GYN  ABVIMS
New Delhi
DELHI 		 09871867700

renucam@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ABVIMS ETHICAL COMITEE  Approved 
institutional ethics comitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O048||(Induced) termination of pregnancywith other and unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  45.00 Day(s)
Gender  Female 
Details  Self managed abortions which report to hospital with complications 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to study the outcome of self managed abortions admitted to hospital  to study the complications of self managed abortions admitted to hospital till discharge/death 
 
Secondary Outcome  
Outcome  TimePoints 
Need of blood ,laprotomy , icu admission,dialysis  18 months 
 
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   N/A 
Date of First Enrollment (India)   22/09/2025 
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="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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [renucam@yahoo.co.in].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

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

Self-managed abortion, where individuals terminate their pregnancies without the direct supervision of a healthcare provider, is a growing phenomenon globally. The increasing availability of abortion drugs has made it possible for individuals to self-manage their abortions. However, there is a significant knowledge gap about the safety, efficacy, and outcomes of self-managed abortions. This will be to analyse the results of SMA that leads to seeking medical help due to some complication, and understanding the client experience of SMA.

 
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