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CTRI Number  CTRI/2022/04/041583 [Registered on: 01/04/2022] Trial Registered Prospectively
Last Modified On: 31/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare Carbetocin with Oxytocin in Caesarean section for prevention of Post-partum haemorrhage(PPH) at a tertiary Institute: A randomised controlled study 
Scientific Title of Study   Effectiveness of Carbetocin in Caesarean section for prevention of Post-partum haemorrhage(PPH) in comparison with Oxytocin at a tertiary Institute: A randomised controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Khumanthem Pratima Devi 
Designation  Assistant Professor 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Obstetrics and Gynaecology RIMS Imphal Manipur

Imphal West
MANIPUR
795004
India 
Phone  9612001318  
Fax    
Email  pratimadutta09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Khumanthem Pratima Devi 
Designation  Assistant Professor 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Obstetrics and Gynaecology RIMS Imphal Manipur

Imphal West
MANIPUR
795004
India 
Phone  9612001318  
Fax    
Email  pratimadutta09@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ranjeeta Angomchanu 
Designation  Senior Resident 
Affiliation  Regional Institute of Medical Sciences Imphal 
Address  Department of Obstetrics and Gynaecology RIMS, Lamphelpat Imphal West Manipur

Imphal West
MANIPUR
795004
India 
Phone  8007901018  
Fax    
Email  dr.ranjeeta.angom@gmail.com  
 
Source of Monetary or Material Support  
Regional Institute of Medical sciences Imphal Golden Jubilee Initiative 
 
Primary Sponsor  
Name  RIMS Imphal Golden Jubilee research Initiative 
Address  RIMS Lamphelpat Imphal West Manipur Pin 795004 
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 
Pratima Khumanthem  Regional Institute of Medical Sciences hospital  Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR 		 9612001318

pratimadutta09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICAL BOARD RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All term pregnant women undergoing Caesarean section in Regional Institute of Medical Sciences Imphal in Department of Obstetrics nd Gynaecology. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Carbetocin 100 microgram   173 women will be receiving interventional drug Injection carbetocin 100 microgram IV bolus slowly immediately after delivery. 
Comparator Agent  Injection Oxytocin  Control group comprising of 173 women will be receiving Injection Oxytocin 10 IU in 500 ml Ringer Lactate IV infusion.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Term Pregnant women reporting to the department of Obstetrics & Gynaecology who will be undergoing caesarean section and giving informed consent in the Regional Institute of Medical Sciences, a tertiary care centre of Imphal, Manipur 
 
ExclusionCriteria 
Details  Presence of Hypertension, antepartum haemorrhage, fibroid uterus or history of myomectomy, cardiac, renal or liver diseases, epilepsy, bleeding disorders, general anaesthesia and history of hypersensitivity to any drugs. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the amount of blood loss as well as the uterine tone following carbetocin and oxytocin in caesareansection  Blood loss, Uterine tone and Vitals are monitored immediately, 2 hours and 24 hours after delivery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of the drugs in terms of additional interventions needed and drop in haemoglobin  On admission and 24 hours after delivery 
 
Target Sample Size   Total Sample Size="346"
Sample Size from India="346" 
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   N/A 
Date of First Enrollment (India)   05/04/2022 
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="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1. Say L, Chou D, Gemmill A, Tunçalp Ö, Moller AB, Daniels J, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014;2(6):e323–3. doi:10.1016/S2214-109X (14)70227-X 2. WHO recommendations: uterotonics for the prevention of postpartum haemorrhage. Geneva: World Health Organization; 2018. ISBN 978-92-4-155042-0 Licence: CC BY-NC-SA 3.0 IGO. http://apps.who.int/iris. Accessed on 14th October, 2021 3. Vogel JP, Williams M, Gallos I, Althabe F, Oladapo OT. WHO recommendations on uterotonics for postpartum haemorrhage prevention: what works, and which one? BMJ Glob Health2019;4:e001466.doi:10.1136/bmjgh-2019-001466  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Obstetric haemorrhage, especially postpartum haemorrhage (PPH) is responsible for more than a quarter of all maternal deaths worldwide. In most low-income countries, PPH is the leading cause of maternal deaths. Postpartum haemorrhage occurs in 5-15% of deliveries. The majority of PPH related morbidity and mortality are preventable through effective implementation of  evidenced-based guidelines. Uterine atony is responsible for more than 50% of occurrences of PPH, numerous strategies have been promoted to preserve uterine tone.There are several uterotonic drugs for preventing PPH but it is still debatable which drug is best. Oxytocin (10 IU) is administered for the prevention of PPH in low risk vaginal and caesarean deliveries. Carbetocin is a long-acting synthetic oxytocin analogue, 1-deamino-1- monocarbo-(2-O-Methyltyrosine)-oxytocin, firstly described in 1987. Carbetocin, given as 100 microgram as an IV bolus over 1 minute, instead of continuous infusion of oxytocin with a a similar safety profile and minor antidiuretic effect, in the third stage of labour and in the first 24 hours. Crabetocin is approved by WHO (2018) and included in the WHO (2019) essential medicines drug list. Storage and cold chain maintenance of Oxytocin is difficult unlike heat stable carbetocin in Manipur. Recently it has been approved by drug controller of India for use in prevention of  PPH and is now available in India. In Manipur, carbetocin has not been used and no such study in pregnant women for PPH prevention. 
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