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CTRI Number  CTRI/2024/01/061097 [Registered on: 03/01/2024] Trial Registered Prospectively
Last Modified On: 01/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two drugs efficacy and safety in prevention of PPH in a computer generated randomisation technique  
Scientific Title of Study   Efficacy and safety of carbetocin versus oxytocin in prevention of post partum hemorrhage in high risk women.
An Open label randomised controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SMRITI BAG 
Designation  JUNIOR RESIDENT 
Affiliation  KING GEORGE MEDICAL COLLEGE AND UNIVERSITY  
Address  QUEEN MARY’S HOSPITAL(DEPT OF OBS AND GYANE) ,KGMU, SUBASH MARG,RAJA BAZAAR,CHOWK,LUCKNOW

Lucknow
UTTAR PRADESH
226003
India 
Phone  8984167023  
Fax    
Email  drsmritibag@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MONICA AGRAWAL 
Designation  ADDITIONAL PROFESSOR  
Affiliation  KING GEORGE MEDICAL COLLEGE 
Address  QUEEN MARY’S HOSPITAL,KGMU,SUBASH MARG,RAJA BAZAAR,CHOWK,LUCKNOW

Lucknow
UTTAR PRADESH
226003
India 
Phone  9628667755  
Fax    
Email  dr.monikagrawal@gmail.com  
 
Details of Contact Person
Public Query  
Name  MONICA AGRAWAL 
Designation  ADDITIONAL PROFESSOR  
Affiliation  KING GEORGE MEDICAL COLLEGE 
Address  QUEEN MARY’S HOSPITAL,KGMU,SUBASH MARG,RAJA BAZAAR,CHOWK,LUCKNOW

Lucknow
UTTAR PRADESH
226003
India 
Phone  9628667755  
Fax    
Email  dr.monikagrawal@gmail.com  
 
Source of Monetary or Material Support  
DR SMRITI BAG JUNIOR RESIDENT-3 DEPT OF OBS AND GYNE QUEEN MARYS HOSPITAL KGMU SUBASH MARG,LUCKNOW-226003,UTTARPRADESH 
 
Primary Sponsor  
Name  DR SMRITI BAG 
Address  JUNIOR RESIDENT-3 DEPT OF OBS AND GYNAE QUEEN MARY’S HOSPITAL,KGMU,SUBASH MARG,RAJA BAZAAR,CHOWK,LUCKNOW-226003 
Type of Sponsor  Government 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 SMRITI BAG  Queen Mary’s Hospital(Department of Obstetrics AND Gyanecology)King Georges Medical University  King George’s Medical University Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 8984167023

drsmritibag@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,KGMU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O721||Other immediate postpartum hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CARBETOCIN  SYNTHETIC OXYTOCIN ANALOGUE WITH A LONGER DURATION  
Comparator Agent  OXYTOCIN  Oxytocin injection is a synthetic hormone 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Women of age between 18-35 years of Gestational age of 37-42 weeks
Patients who have given written informed consent Women at risk of PPH including
Factors resulting in overdistention of the uterus 
Multiple gestation (eg, twins)
Fetal macrosomia
Polyhydramnios
Nature of labor and delivery 
Induced labor
Precipitous labor (lasting less than 3 hours)
Prolonged labor
Forceps or vacuum-assisted delivery
Cesarean delivery
Factors relating to the placenta 
Abruptio placentae
Placenta previa
Abnormal implantation
High multiparity 

Preeclampsia 
Chorioamnionitis 
 
Amniotic fluid embolism 
May precipitate disseminated intravascular coagulation, resulting in consumptive coagulopathy and uncontrolled blood loss
Under general Anesthesia 
Medications
Prolonged oxytocin use 
Magnesium sulfate
Anticoagulants
 
 
ExclusionCriteria 
Details  Gestational age less than 37 or more than 42 weeks
History of thromboembolic disorders,
Cases suffering from chronic medical diseases (cardiac, hepatic, renal),
Not giving consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The total amount of blood loss within 24 hours postpartum measured by V drapes
Adverse maternal events like nausea vomiting tachycardia flushing dizziness headache shivering metallic taste dyspnea palpitations itching
Hemodynamic status will be measured at 0 min 30 min 60min 120 min 		 The total amount of blood loss within 24 hours postpartum measured by V drapes 
 
Secondary Outcome  
Outcome  TimePoints 
Need for second line uterotonics and interventions
Need of blood and blood products
Difference between hemoglobin before and after 24 hours of delivery
Difference between hematocrit before and after 24 hours of delivery 		 24 hours 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 3 
Date of First Enrollment (India)   09/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/01/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
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 - NO
Brief Summary  
 Ethical clearance and informed consent will be done.

Information on age, education, parity, occupation and obstetric history was obtained from the mother using a questionnaire

Using a computer generated randomisation sequence, women eligible in the study will be randomly divided into two equal groups with at least one risk factor and a prospective open blinded randomised study will be conducted on 120 (60 in each group) pregnant women divided equally between two groups

  • Group 1- Oxytocin group
  • Group 2 - Carbetocin group
 
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