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CTRI Number  CTRI/2026/03/105896 [Registered on: 11/03/2026] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Which drug combination best prevents heavy bleeding after child birth, carbetocin-methylergometrine or oxytocin-methylergometrine; a hospital study. 
Scientific Title of Study   COMPARISON OF OXYTOCIN WITH METHYLERGOMETRINE VERSUS CARBETOCIN WITH METHYLERGOMETRINE FOR PREVENTION OF POST PARTUM HAEMORRHAGE IN A TERTIARY CARE HOSPITAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  D Krishnananda Varun 
Designation  Post Graduate Trainee 
Affiliation  Silchar Medical College and Hospital  
Address  Department of Anesthesiology and Critical care, Silchar Medical College and Hospital, Silchar, Cachar, Assam.

Cachar
ASSAM
788014
India 
Phone  9567097326  
Fax    
Email  krishnanandret@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepannita Sutradhar 
Designation  Associate Professor 
Affiliation  Silchar Medical College and Hospital  
Address  Department of Anesthesiology and Critical care, Silchar Medical College and Hospital, Silchar, Cachar, Assam.

Cachar
ASSAM
788014
India 
Phone  7002209146  
Fax    
Email  dipanitasutradhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  D Krishnananda Varun 
Designation  Post Graduate Trainee 
Affiliation  Silchar Medical College and Hospital  
Address  Department of Anesthesiology and Critical care, Silchar Medical College and Hospital, Silchar, Cachar, Assam.


ASSAM
788014
India 
Phone  9567097326  
Fax    
Email  krishnanandret@gmail.com  
 
Source of Monetary or Material Support  
Silchar Medical college and Hospital, Cachar, 788014  
 
Primary Sponsor  
Name  D Krishnananda Varun  
Address  Department of Anesthesiology and Critical care, Silchar Medical College and Hospital, Silchar, Cachar, Assam, India Pin 788014  
Type of Sponsor  Other [self] 
 
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 
D Krishnananda Varun  Silchar Medical College and Hospital  Department of Obstetrics and Gynaecology, MCH building, Silchar Medical college and Hospital, Cachar Assam pin 788014
Cachar
ASSAM 
9567097326

krishnanandret@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SILCHAR 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: O720||Third-stage hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  carbetocin with methylergometrine  100 mcg of carbetocin iv over 2 minutes and 200 mcg methylergometrine after umbilical cord clamping 
Comparator Agent  oxytocin and methylergometrine  10 IU of oxytocin in 1000ml of ringers lactate infusion and 200 mcg of methylergometrine after umbilical cord clamping 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Women aged more than 18 years
Women posted for caesarean section delivery in SMCH
ASA I and II
 
 
ExclusionCriteria 
Details  Patient refusal
Eclampsia and HELLP syndrome
Contraindication to Spinal anaesthesia  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine whether oxytocin- methylergometrine or carbetocin-methylergometrine is more effective in preventing intraoperative blood loss and better maintain vitals like heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure during caeserean section surgeries.  Outcomes will be measured at 5 min, 10 min, 15 min, 20 min, 25 min, and 30 min, and 1 hour post administration. 
 
Secondary Outcome  
Outcome  TimePoints 
to compare the hemodynamic outcome and uterine atony.
 
Uterine tone was assessed by the surgeon at 5, 10, 15, and 30 minutes post-administration.
 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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 2/ Phase 3 
Date of First Enrollment (India)   22/03/2026 
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="0"
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  
Caesarean section is a recognized risk factor for Post-Partum Haemorrhage (PPH) and the worldwide caesarean delivery rate is increasing. The caesarean section is an operation where about 750 to 1000ml of blood is lost. When this becomes more than 1000ml, it is called post partum haemorrhage. In developing countries, PPH is one of the main cause of maternal deaths. Uterine atony is most common cause of immediate heavy PPH. Main causes are: PPH due to retained placenta

PPH due to uterine atony occurring within 24 hours following delivery

Delayed and secondary PPH occurring after the first 24 hours following delivery

PPH due to a coagulation defects

The administration of oxytocin after the delivery of the neonate reduces the likelihood of PPH. However, the use of additional uterotonic medication is common, to arrest bleeding, or sometimes used prophylactically if there are anticipated risk factors for PPH.

Oxytocin is a neurohypophysial hormone primarily recognized for its role in parturition and lactation. It is widely used as a uterotonic agent to induce and augment labour, as well as to prevent postpartum haemorrhage. Its mechanism of action is complex and involves multiple pathways that regulate uterine contractility.

Carbetocin, a synthetic long-acting analogue of oxytocin, has emerged as a promising alternative due to its extended duration of action and efficacy in maintaining uterine contraction. Carbetocin functions by mimicking oxytocin, a naturally occurring hormone responsible for uterine contractions during labour and postpartum uterine involution. Its pharmacological mechanism involves the activation of oxytocin receptors in the myometrium, leading to sustained uterine contractions that prevent excessive bleeding.
 
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