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CTRI Number  CTRI/2022/06/043237 [Registered on: 14/06/2022] Trial Registered Prospectively
Last Modified On: 28/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Carbetocin vs Oxytocin for prevention of haemorrhage after delivery in women undergoing Caesarean section  
Scientific Title of Study   Comparison of Carbetocin versus Oxytocin for Prevention of Primary Postpartum Haemorrhage in Women Undergoing Caesarean Section at a Tertiary Care Hospital in West Bengal: A Randomised Recipient Blinded Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Isha Sudrania 
Designation  Associate Professor 
Affiliation  IQ City Medical College Hospital 
Address  Department of Obstetrics and Gynaecology IQ City Medical College Hospital Sovapur Bijra Road Jemua Durgapur

Barddhaman
WEST BENGAL
713206
India 
Phone  7502707024  
Fax    
Email  isha107@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shouvik Das 
Designation  Assistant Professor 
Affiliation  IQ City Medical College Hospital 
Address  Department of Obstetrics and Gynaecology IQ City Medical College Hospital Sovapur Bijra Road Jemua Durgapur

Barddhaman
WEST BENGAL
713206
India 
Phone  8478948603  
Fax    
Email  drdasshouvik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shouvik Das 
Designation  Assistant Professor 
Affiliation  IQ City Medical College Hospital 
Address  Department of Obstetrics and Gynaecology IQ City Medical College Hospital Sovapur Bijra Road Jemua Durgapur

Barddhaman
WEST BENGAL
713206
India 
Phone  8478948603  
Fax    
Email  drdasshouvik@gmail.com  
 
Source of Monetary or Material Support  
IQ City medical college Hospital 
 
Primary Sponsor  
Name  IQ City Medical College Hospital 
Address  Sovapur, Bijra Road, durgapur 713206 
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 ISHA SUDRANIA  IQ City Medical College Hospital  Department of Obstetrics and Gynaecology Sovapur Bijra Road Jemua Durgapur 713206
Barddhaman
WEST BENGAL 
7502707024

isha107@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IQ City Medical College & Hospital, Institutional Ethics Committee  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 
Intervention  Injection Carbetocin  Injection Carbetocin 100 micrograms intravenous given in active management of third stage of labour 
Comparator Agent  Injection Oxytocin  Injection Oxytocin 10 IU intravenous given in active management of third stage of labour 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Age 21 to 45 years
2.Emergency or elective Caesarean section
3.Singleton pregnancy 
 
ExclusionCriteria 
Details  1.Contraindication for carbetocin and oxytocin
known allergy or hypersensitivity to carbetocin or oxytocin
2.Cases of coagulopathy
3.Multifoetal gestation
4.Medical diseases as cardiac, hypertension, liver, renal or endocrine diseases
5.Uterine fibroids
6.Suspected placental pathology (placenta accreta, praevia or abruption)
7.General anaesthesia
8.Classical uterine incision
9.Those who did not give consent
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Volume of blood loss
Use of additional uterotonics 
First 24 hours post-operative 
 
Secondary Outcome  
Outcome  TimePoints 
change in blood pressure  after one hour of drug administration 
change in pulse rate  after one hour of drug administration 
change in haemoglobin  24 hours after lscs 
need of blood transfusion  during first 24 hours post operative 
 
Target Sample Size   Total Sample Size="340"
Sample Size from India="340" 
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)   25/06/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
           Postpartum haemorrhage (PPH) continues to be the leading cause of maternal mortality in middle and low-income countries including India. Much advancement has been made in the field of treatment of PPH, but not much progress has been made in the field of prevention, where one of its main component is administration of uterotonic, preferably oxytocin, immediately after birth of the baby. In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding other uterotonics: Ergometrine degrades when exposed to heat or light and Misoprostol degrades rapidly when exposed to moisture. Innovation in the manufacture of carbetocin has met the stability requirements in hot and humid climates. Both Carbetocin and Oxytocin are approved drugs for active managemrent of third stage of labour (AMTSL) and prevention of PPH. This study has been undertaken to evaluate the uterotonic effect of carbetocin compared to oxytocin for the prevention of primary PPH in emergency or elective Caesarean delivery. The purpose of this study is to determine if carbetocin is superior to oxytocin in terms of reduction in the need of additional uterotonic agents and the occurrence of PPH.
 
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