| 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
|
|
|
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
|
|
|
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. |