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CTRI Number  CTRI/2025/10/096250 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 19/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes 
Study Design  Other 
Public Title of Study   To compare the difference in the amount of blood loss during the first 24 hours after cesarean section on giving intrauterine misoprostol in one group and per rectal misoprostol in another group 
Scientific Title of Study   Intrauterine Misoprostol Versus per Rectal Misoprostol During Cesarean Section to Prevent Primary Postpartum Hemorrhage-- A Comparative analysis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhumanti Banerjee 
Designation  Post graduate trainee 
Affiliation  MIDNAPORE MEDICAL COLLEGE AND HOSPITAL  
Address  Dept of gynaecology and obstetrics, MidnaporeMedicalCollegeandHospital, vidyasagar road ,west mindapore

Medinipur
WEST BENGAL
721101
India 
Phone  8777018850  
Fax    
Email  dhu.manti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Snehamay Chaudhuri  
Designation  Professor 
Affiliation  Midnapore medical college and hospital  
Address  Dept of Gynaecology and Obstetrics, Midnapore medical college and hospital, vidyasagar road , midnapore, w medinipur

Medinipur
WEST BENGAL
721101
India 
Phone  9830538366  
Fax    
Email  snehamay_chaudhuri_dr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Snehamay Chaudhuri  
Designation  Professor 
Affiliation  Midnapore medical college and hospital  
Address  Dept of Gynaecology and Obstetrics, Midnapore medical college and hospital, vidyasagar road , midnapore, w medinipur

Medinipur
WEST BENGAL
721101
India 
Phone  9830538366  
Fax    
Email  snehamay_chaudhuri_dr@yahoo.com  
 
Source of Monetary or Material Support  
Midnapore medical college and hospital, vidyasagar road, medinipur, west Midnapore, pin 721101, state : West Bengal, country: India  
 
Primary Sponsor  
Name  Madhumanti Banerjee  
Address  Dept of Gynaecology and Obstetrics, Midnapore medical College and hospital, vidyasagar road, midnapore, w medinipur  
Type of Sponsor  Other [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 Snehamay Chaudhuri  Midnapore medical College and hospital   Department of Gynaecology and Obstetrics
Medinipur
WEST BENGAL 		 9830538366

snehamay_chaudhuri_dr@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O720||Third-stage hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Per rectal misoprostol  Per rectal misoprostol 800 mcg immediate post operatively 
Intervention  Use of intrauterine misoprostol in preventing primary post partum hemorrhage during cesarean section   400 mcg misoprostol will be introduced intrauterine ( 200mcg in each cornu) in first group  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Women bearing full term singleton healthy living fetus with gestational age more than 37 weeks either confirmed from first date of last menstrual period or first trimester ultrasound scan  
 
ExclusionCriteria 
Details  Women with pre operative hemoglobin less than 9gm/dl , concomittant medical disorders, more than two previous cesarean section, allergic to prostaglandin, with higher risk of post partum hemorrhage ( abnormal placentation, twin pregnancy, previous history of uterine atony or PPH, polyhydramnios,uterine fibroids ) , women in whom cesarean section lasts for more than 90 minutes  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study efficacy and safety of intrauterine misoprostol in preventing primary post partum hemorrhage during cesarean section as compared to per rectal misoprostol during cesarean section   24hours 
 
Secondary Outcome  
Outcome  TimePoints 
1) to compare use of additional uterotonics following intrauterine misoprostol administration
2) to compare blood transfusion following intrauterine misoprostol administration
3) to compare hospital stay following intrauterine misoprostol administration
4) to study side effects of misoprostol  		 24hours  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 1 
Date of First Enrollment (India)   01/11/2025 
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 - NO
Brief Summary   A study where we compare the effectiveness of intrauterine misoprostol as compared to per rectal misoprostol during cesarean section in controlling primary post partum hemorrhage. The patients fitting the inclusion criteria will be subjected to the study after proper consent and the effectiveness will be measured with the help of a formula based primarily on the basis of difference in the hematocrit and other factors like mop soakage and suction drain content.  
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