| CTRI Number |
CTRI/2025/03/082261 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of carbetocin vs oxytocin in elective lscs in prevention of bleeding aftert caesarean delivery |
|
Scientific Title of Study
|
Randomized Control Trial to compare Carbetocin and Oxytocin in the prevention of
Postpartum Hemorrhage (PPH) in Elective Caesarean Section |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandyarani Dodamani |
| Designation |
Resident |
| Affiliation |
INHS Asvini |
| Address |
INHS Asvini
Colaba, Mumbai
Dept of Obs and Gyn
Institute of Naval Medicine
Near RC Church Colaba
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8660706564 |
| Fax |
|
| Email |
dr.sandhyarani.d@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tina SIngh |
| Designation |
Associate Professor |
| Affiliation |
INHS Asvini |
| Address |
Dept of Obs and Gyn
Institute of Naval Medicine
Near RC Church Colaba
Dept of Obs and Gyn
Institute of Naval Medicine
Near RC Church Colaba
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9387879088 |
| Fax |
|
| Email |
afmctina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandyarani Dodamani |
| Designation |
Resident |
| Affiliation |
INHS Asvini |
| Address |
INHS Asvini,
Colaba, Mumbai
Dept of Obs and Gyn
Institute of Naval Medicine
Near RC Church Colaba
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8660706564 |
| Fax |
|
| Email |
dr.sandhyarani.d@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Obs and Gyn clinic2
Indian Naval Hospital Ship Asvini Near RC Church Colaba, Mumbai, India, 400005 |
|
|
Primary Sponsor
|
| Name |
Indian Naval Hospital Ship Asvini |
| Address |
Near RC Church, Colaba, Mumbai, India 400005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sandyarani Dodamani |
Institute of Naval Medicine |
Dept of Obstetrics & Gynaecology, Clinic 2, Near RC Church, Colaba, Mumbai 400005
Mumbai
MAHARASHTRA |
8660706564
dr.sandhyarani.d@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INHS ASVINI ETHICS Committee |
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 |
Inj Carbetocin |
ALl patients ubdergoing elective LSCS will be adminsitred Inj Carbetocin 100 microgram iv and observed fdor 48 hours |
| Comparator Agent |
Oxytocin |
all pateints other than where carrbetocin is used will be adminstered Inj Oxytocin 10 units iv and observed for 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
all willing pts
term pregnancies undergoing elective lscs |
|
| ExclusionCriteria |
| Details |
all unwilling pts, emergency LSCS,pts with cardiac disease,renal disease,liver disease, epilepsy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Carbetocin is better compared to Oxytocin in prevention of Post partum haemorrhage |
till 48 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Carbetocin is similar to Oxytocin in prevention of post partum haemorrhage |
till 48 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sandhyarani.d@gmail.com].
- For how long will this data be available start date provided 01-05-2024 and end date provided 01-07-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Postpartum hemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide, accounting for around one-fourth of all maternal deaths. Elective Caesarean Section (ECS) is a known risk factor for PPH, with an incidence of PPH ranging from 3.3% to 6.5%. Oxytocin is the current standard of care for the prevention of PPH during ECS, with certain limitations, such as need for refrigeration and short half-life. Carbetocin is a newer uterotonic drug that has shown to be as effective as oxytocin in the prevention of PPH, with the added advantage of longer half-life and no need of refrigeration. However, there is a lack of data on the comparative effectiveness of Carbetocin and Oxytocin in preventing PPH during ECS. |