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CTRI Number  CTRI/2023/09/057333 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 10/09/2023
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   Comparative study of uterotonic agents in the prevention of post partum haemorrhage following vaginal delivery 
Scientific Title of Study   Comparative study of Carbetocin vs Oxytocin in the prevention of post partum haemorrhage following vaginal delivery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Revathi Mallikarjuna 
Designation  Post graduate  
Affiliation  Ramaiah Medical College and teaching hospital  
Address  Ramaiah medical college and hospital Junior resident, department of OBG Mathikere, msr nagar, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9480708128  
Fax    
Email  revathi8205@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamatha 
Designation  Assistant professor  
Affiliation  Ramaiah Medical College and teaching hospital  
Address  Ramaiah medical college and teaching hospital, department of OBG

Bangalore
KARNATAKA
560054
India 
Phone  9535208686  
Fax    
Email  mamatha750@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Revathi Mallikarjuna 
Designation  Post graduate  
Affiliation  Ramaiah Medical College and teaching hospital  
Address  Junior resident, Ramaiah medical college and teaching hospital, department of OBG,

Bangalore
KARNATAKA
560054
India 
Phone  9480708128  
Fax    
Email  revathi8205@gmail.com  
 
Source of Monetary or Material Support  
M S Ramaiah Medical College and hospital Department of Obstetrics and Gynaecology  
 
Primary Sponsor  
Name  Ramaiah medical college  
Address  MSR Nagar Bangalore  
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 Revathi   Ramaiah medical college and hospital   Department of OBG, labour room, Msr nagar, Bangalore
Bangalore
KARNATAKA 
9480708128

revathi8205@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ramaiah medical college   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  Injection Carbetocin for management of third stage of labour   Injection Carbetocin 100 micrograms Single dose, intravenous route will be administered without any other confounding factor to subjects and then compared with the subjects who have been administered injection oxytocin 10 international units IV with or without additional uterotonic agents. The study is done for a period of 18 months 
Intervention  Intravenous Administration of injection Carbetocin  Injection Carbetocin 100 micrograms single dose intravenous route will be administered without any other confounding factor to subjects and then compared with the subjects who have been administered injection oxytocin 10IU with or without additional uterotonic agents. The study is done for a period of 18 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  (1) at or beyond 28 gestational weeks; (2) 18–45 years old; (2) at least one risk factor for developing atony.
 
 
ExclusionCriteria 
Details  Participants with cardiovascular disorders, hepatic or renal disease, epilepsy, known allergies to oxytocin or carbetocin.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The aim of the study is to compare the effects of carbetocin with those of oxytocin in several dosing regimens for the prevention of uterine atony in patients undergoing full term vaginal delivery. The outcome is assessed in terms of blood loss, need for additional uterotonic agents, fall in blood pressure, side effects of the drug Carbetocin if any
 
Outcome is assessed immediately after delivery and 12 hours, 24 hours after delivery. 
 
Secondary Outcome  
Outcome  TimePoints 
This study is aimed at comparing the effects of carbetocin vs oxytocin in prevention of postpartum hemorrhage following vaginal delivery in terms of:
Secondary outcomes -
Fall in hb
Requirement of additional uterotonic agents
Adverse effects
Need for blood transfusion  
Outcome is assessed immediately after delivery, 12 hours & 24 hours  
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   10/09/2023 
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="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study includes all women who have delivered vaginally . Quantification of blood loss is done by making a list of  dry weights for delivery items that may become blood soaked with directions on how to calculate blood loss.  Quantification of blood loss is begun immediately after the infant’s birth (before delivery of the placenta) and  the amount of fluid collected in a calibrated under-buttocks drape is assessed and recorded. Most of the fluid collected before delivery of the placenta is amniotic fluid, urine, and feces. If irrigation is used, the amount of irrigation from the total fluid that was collected is subtracted. The total volume of fluid collected in the under-buttocks drape is recorded. The preplacental fluid volume is subtracted from the post placental fluid volume to more accurately determine the actual blood loss. Most of the fluid collected after the delivery of the placenta is blood. The fluid volume collected in the drapes is added to the blood volume measured by weighing soaked items to determine the cumulative volume of blood loss or quantification of blood loss. All blood-soaked materials and clots are weighed to determine cumulative volume. 1 gram weight=1 milliliter blood loss volume. The equation* used when calculating blood loss of a blood-soaked item is WET Item Gram Weight - DRY Item Gram Weight=Milliliters of Blood Within the Item.. [10, 11, 12]

Randomized controlled trials with outcome measure of blood loss ≥500ml are eligible if they compared carbetocin with oxytocin to prevent postpartum hemorrhage during prophylaxis of PPH in women following vaginal delivery. The primary outcome is blood loss of at least 500ml after vaginal delivery. The secondary outcomes will be blood loss of at least 1000ml; use of additional uterotonic agents; blood transfusion; uterine massage; flushing; vomiting; abdominal pain; nausea; dizziness; headache; palpitation; itching; shivering.

Side-effects are also an important concern when choosing uterotonic agents. Although carbetocin seems to be an ideal agent compared to other uterotonic agents, some side-effects, such as vomiting, nausea, and dysarteriotony, are still concerning. Side-effects are also considered as secondary outcomes in these trials. Clinicians do not fully understand the side-effects of carbetocin to PPH, particularly the unanticipated ones. There seems to be a gap in the detailed presentation of the side-effects of carbetocin. Therefore, this study also aims to assess the side-effects of  carbetocin compared to oxytocin in the prevention of PPH

Carbetocin 100mcg IV will be administered without any other confounding factor to subjects and then compared with the subjects who have been administered oxytocin 10IU with additional uterotonic agents.

 
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