| CTRI Number |
CTRI/2025/11/097373 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of two drugs ( heat stable carbetocin versus oxytocin ) to minimize postpartum haemorrhage during labour. |
|
Scientific Title of Study
|
Efficacy of heat stable carbetocin versus oxytocin to minimize postpartum haemorrhage during labour - A 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 |
Keerthana S |
| Designation |
Postgraduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department Of Obstetrics and Gynaecology, A-Block, NO-22,
Aarupadai Veedu Medical College and Hospital,
Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.
Pondicherry
PONDICHERRY
607403
India |
| Phone |
7868056133 |
| Fax |
|
| Email |
keerthanakavitha6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa S |
| Designation |
Professor and HOD of Obstetrics and Gynaecology |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department Of Obstetrics and Gynaecology, A-Block, NO-22,
Aarupadai Veedu Medical College and Hospital,
Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.
Pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8012081902 |
| Fax |
|
| Email |
deepa.shanmugam@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Keerthana S |
| Designation |
Postgraduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department Of Obstetrics and Gynaecology, A-Block, NO-22,
Aarupadai Veedu Medical College and Hospital,
Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.
Pondicherry
PONDICHERRY
607403
India |
| Phone |
7868056133 |
| Fax |
|
| Email |
keerthanakavitha6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college and hospital, Pondy Cuddalore Main road Kirumampakkam
Bahour, Kirumampakkam, Puducherry 607402.
|
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu medical college and hospital |
| Address |
Department Of Obstetrics and Gynaecology, A-Block, NO-22,
Aarupadai Veedu Medical College and Hospital,
Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Keerthana S |
Aarupadai Veedu medical college and hospital |
Department Of
Obstetrics and
Gynaecology, A-Block,
NO-22, Aarupadai
Veedu Medical College
and Hospital,
Pondicherry-Cuddalore
Main Road,
Kirumampakkam,
Pondicherry.
Pondicherry
PONDICHERRY |
7868056133
keerthanakavitha6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Research Foundation INSTITUTE ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Carbetocin |
100mg - single dose given Intra muscularly. |
| Comparator Agent |
Oxytocin |
10 IU- single dose given Intra muscularly. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal mothers more than 18 years who are undergoing delivery in AVMCH
|
|
| ExclusionCriteria |
| Details |
1.Mothers with hypertension /pre-eclampsia
2.Multiple pregnancy
3.Mothers with coagulation disorder
4.Mothers with CNS disorders
5.Mothers with liver or kidney disease
6.Hypersensitivity or contraindication to carbetocin/oxytocin
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of Heat stable Carbetocin when compared to oxytocin to minimize blood loss thus preventing Post-partum Hemorrhage. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the efficacy of heat stable Carbetocin & oxytocin to minimize blood loss during labour.
2. To study the side effects of Heat stable Carbetocin.
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
09/11/2026 |
| 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="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
|
After getting IEC clearance from the institute and CTRI registration, informed and written consent
from the patient who are willing to get enrolled in the study. A total of 144 antenatal mothers (>18 years) undergoing delivery in AVMCH will be included and randomly assigned to receive either heat stable carbetocin or oxytocin. Participants with hypertension, pre-eclampsia, multiple pregnancy, coagulation disorders, liver, or kidney disorders will be excluded. Data will be collected on blood loss, hemoglobin changes, need for additional uterotonics, and side effects using a structured proforma for analysis of outcome. |