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CTRI Number  CTRI/2024/12/078621 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 19/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   The minimum Effective Dose of Carbetocin In Preventing Postpartum Hemorrhage In Cesarean Delivery. 
Scientific Title of Study   The minimum Effective Dose of Carbetocin In Preventing Postpartum Hemorrhage In Cesarean Delivery : A Factorial Randomized 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  Dr Riya Abraham 
Designation  First Year Post Graduate 
Affiliation  Aarupadai veedu medical college and hospital 
Address  Department Of Anaesthesiology First Floor A Block Aarupadai Veedu Medical College and hospital Kirumampakkam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8892287100  
Fax    
Email  riyaabraham.avarachan@avmc.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Prabhu 
Designation  Associate Professor 
Affiliation  Aarupadai veedu medical college and hospital 
Address  Department Of Anaesthesiology First Floor A Block Aarupadai Veedu Medical College and hospital Kirumampakkam Pondicherry.

Pondicherry
PONDICHERRY
607402
India 
Phone  9843360106  
Fax    
Email  cr.prabhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akshaya M 
Designation  Assistant Professor 
Affiliation  Aarupadai veedu medical college and hospital 
Address  Department Of Anaesthesiology First Floor A Block Aarupadai Veedu Medical College and hospital Kirumampakkam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  8056787520  
Fax    
Email  akshayndu1026@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology first floor A block Aarupadai veedu medical college and hospital Kirumampakkam Pondicherry 607402 India 
 
Primary Sponsor  
Name  Aarupadai veedu medical college and hospital 
Address  Aarupadai veedu medical college and hospital Kirumampakkam Pondicherry cuddalore highway Pondicherry Pondicherry 607402 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 Riya Abraham  Aarupadai veedu medical college and hospital  Department Of Anaesthesiology First Floor A Block Aarupadai Veedu Medical College and hospital, Kirumampakkam Pondicherry cuddalore highway Pondicherry
Pondicherry
PONDICHERRY 		 8892287100

riyaabraham.avarachan@avmc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethical committee aarupadai veedu medical college and hospital  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 
Intervention  Injection Carbetocin 100mcg IV  Parturient undergoing Cesarean section will be given Injection Carbetocin 100mcg IV diluted to 10ml and given over 1minute after delivery of the head and obstetrician will assess the uterine contraction as satisfactory or unsatisfactory at 2minutes, 5minutes and 10 minutes. Maximum duration of total intervention is 10minutes. 
Comparator Agent  Injection Carbetocin 20mcg IV  Parturient undergoing Cesarean section will be given Injection Carbetocin 20mcg IV diluted to 10ml and given over 1minute after delivery of the head and obstetrician will assess the uterine contraction as satisfactory or unsatisfactory at 2minutes, 5minutes and 10 minutes 
Comparator Agent  Injection Carbetocin 40mcg IV  Parturient undergoing Cesarean section will be given Injection Carbetocin 40mcg IV diluted to 10ml and given over 1minute after delivery of the head and obstetrician will assess the uterine contraction as satisfactory or unsatisfactory at 2minutes, 5minutes and 10 minutes 
Comparator Agent  Injection Carbetocin 60mcg IV  Parturient undergoing Cesarean section will be given Injection Carbetocin 60mcg IV diluted to 10ml and given over 1minute after delivery of the head and obstetrician will assess the uterine contraction as satisfactory or unsatisfactory at 2minutes, 5minutes and 10 minutes 
Comparator Agent  Injection Carbetocin 80mcg IV  Parturient undergoing Cesarean section will be given Injection Carbetocin 80mcg IV diluted to 10ml and given over 1minute after delivery of the head and obstetrician will assess the uterine contraction as satisfactory or unsatisfactory at 2minutes, 5minutes and 10 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Parturients undergoing cesarean section under spinal anaesthesia.
ASA II AND III physical status. 
 
ExclusionCriteria 
Details  Patient Refusal
Parturients who are having conditions predisposing to PPH
Twin pregnancy, Abnormal placenta, Pre eclampsia, Advanced maternal age more than 35years, BMI more than 35Kg/m2, Anemia Hb less than 8gm% 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the minimum dose of carbetocin to achieve effective uterine contraction.  2minutes, 5minutes, 10minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess intraoperative blood loss and blood loss in 24 hours across various doses of carbetocin.
To assess additional requirements of uterotonic agents from delivery up to 24 hours post surgery.
To assess hemodynamic parameters across different doses of carbetocin. 		 24 hours
24 hours
24 hours 
 
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   Phase 4 
Date of First Enrollment (India)   17/01/2025 
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   Postpartum haemorrhage (PPH) is the leading cause of maternal mortality and morbidity. Most common cause of PPH is failure of adequate uterine contractions or uterine anomalies. Administration of uterotonic drugs during cesarean section diminishes the risk of PPH. Carbetocin is a synthetic analogue of oxytocin with 4-10 times longer half life than oxytocin and it is heat stable.  The recommended dose of Carbetocin is 100mcg IV by SOGC as uterotonic in cesarean deliveries. Am doing a study to find the least  dose of carbetocin that can produce effective and satisfactory uterine contractions in parturients undergoing cesarean section under spinal anaesthesia. They are allotted into five groups to receive five different doses of carbetocin namely Group A 100mcg, Group B 80mcg, Group C 60mcg, Group D 40mcg, Group E 20mcg.The obstetrician will assess the uterine contraction as satisfactory or unsatisfactory at 2minutes, 5minutes, 10minutes after carbetocin administration. If at 5minutes uterine contraction is inadequate , the patient will be managed according to FIGO Recommendations 2022. 
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