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CTRI Number  CTRI/2025/09/094276 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To check effect of intrauterine and sublingual and per rectal misoprostol in C-section for blood loss during and after delivery . 
Scientific Title of Study   To evaluate efficacy of intrauterine and sublingual and per rectal misoprostol during cesarean section in controlling postpartum haemorrhage. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrHarvir Kaur  
Designation  Pg resident  
Affiliation  Adesh university  
Address  Department of obgyne, Adesh Institute of Medical Sciences and Research, Bathinda, 151001 , Punjab , India

Bathinda
PUNJAB
151001
India 
Phone  9501137595  
Fax    
Email  harvirkaur215@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mini bedi 
Designation  Professor  
Affiliation  Adesh university  
Address  Department of obgyne, Adesh Institute of Medical Sciences and Research, Bathinda, 151001 , Punjab , India

Bathinda
PUNJAB
151001
India 
Phone  8198884222  
Fax    
Email  drmbsandhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrHarvir Kaur  
Designation  Pg resident  
Affiliation  Adesh university  
Address  Department of obgyne, Adesh Institute of Medical Sciences and Research, Bathinda, 151001 , Punjab , India


PUNJAB
151001
India 
Phone  9501137595  
Fax    
Email  harvirkaur215@gmail.com  
 
Source of Monetary or Material Support  
Adesh university, Bathinda , 151001 , Punjab , India  
 
Primary Sponsor  
Name  Adesh university  
Address  Adesh Institute of Medical Sciences and Research, Bathinda, 151001 , Punjab , India 
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 Harvir kaur  Adesh institute of medical sciences and research   OBGYNE department, Bathinda, Punjab
Bathinda
PUNJAB 		 9501137595

harvirkaur215@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee adesh university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  intrauterine, sublingual and per rectal misoprostol  600mcg misoprostol given through different route like intrauterine sublingual per rectal for pph control 
Intervention  Misoprostol   600mcg misoprostol in caesarean section in controlling postpartum haemorrhage by intrauterine/sublingual/per rectal routes  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  All pregnant women undergoing caesarean section 
 
ExclusionCriteria 
Details  Women with pre-existing coagulopathies, uterine anomalies, or known hypersensitivity
to prostaglandins.
Patients with known as asthma, cardiac disease, acute angle closure glaucoma .Traumatic postpartum hemorrhage during caesarean section.Scar rupture
Angle extension.Uterine artery cut.Scar dehiscence. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intraoperative and postoperative blood loss  During c section after placenta out and for next 48hrs post delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Need for blood transfusion  Upto 48hrs post operative 
 
Target Sample Size   Total Sample Size="147"
Sample Size from India="147" 
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 
Date of First Enrollment (India)   16/09/2025 
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 Applicable 
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 -  Study Protocol
    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 [harvirkaur215@gmail.com].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   In all c sections after placenta out misoprostol 600mcg will be kept by different routes like intrauterine sublingual and per rectal and the amount of blood loss will be measured  and after the delivery patient will be kept under observation for any blood loss till 48hrs. 
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