| CTRI Number |
CTRI/2025/10/096663 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| 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
|
A clinical trial to compare the efficacy of Carbetocin and Oxytocin in preventing post partum haemorrhage in elective caesarean sections |
|
Scientific Title of Study
|
A Open labelled Randomised controlled trial to compare the efficacy of Carbetocin and Oxytocin in preventing post partum haemorrhage in uncomplicated elective caesarean sections at a tertiary care centre in Telangana |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PALATI BHARGAVI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
Hyderabad
TELANGANA
508126
India |
| Phone |
8919995419 |
| Fax |
|
| Email |
palatibhargavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NABNITA PATNAIK |
| Designation |
HOD AND ADDITIONAL PROFESSOR ,DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
Hyderabad
TELANGANA
508126
India |
| Phone |
8919995419 |
| Fax |
|
| Email |
drnabnitapatnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NABNITA PATNAIK |
| Designation |
HOD AND ADDITIONAL PROFESSOR ,DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
TELANGANA
508126
India |
| Phone |
8919995419 |
| Fax |
|
| Email |
drnabnitapatnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCESBIBINAGAR |
| Address |
AIIMS BIBINAGAR, 508126 |
| 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 |
| DRPALATI BHARGAVI |
AIIMS BIBINAGAR |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
Hyderabad
TELANGANA |
89199 95419
palatibhargavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(AIIMS BBN-IEC) |
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 |
UTEROTONIC AGENT
100mcg IV in 10ml NS over 10 min |
| Comparator Agent |
OXYTOCIN |
UTEROTONIC AGENT
10IU in 500mlNS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women 37 weeks of gestation
Age 18 to 45 years
Uncomplicated elective caesarean section Singleton pregnancy |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the amount of intra operative blood loss in uncomplicated elective caesarean sections |
To estimate the amount of intra operative blood loss after placental delivery in uncomplicated elective caesarean sections |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Estimation of postpartum blood loss within 24 hours following uncomplicated elective caesarean sections
2)Assessment of the requirement for other interventions like additional uterotonics/ haemostatic agents/ surgical methods for the management of the haemorrhage.
3)Evaluation of the need for blood transfusion & fall in postpartum haemoglobin levels during follow-up.
4) to evaluate & compare the adverse effects of carbetocin & oxytocin.
|
Estimation of postpartum blood loss within 24 hours following uncomplicated elective caesarean sections |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/11/2025 |
| 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="1"
Months="6"
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
|
open-label randomized controlled trial aims to compare the efficacy of carbetocin versus oxytocin in preventing postpartum hemorrhage (PPH) following uncomplicated elective caesarean sections. The study will be conducted over 18 months at AIIMS Bibinagar, involving 200 pregnant women randomly assigned to receive either carbetocin or oxytocin during surgery. Intraoperative blood loss will be measured using mop weight and suction canister volume, while postpartum blood loss will be visually estimated over 24 hours. Secondary outcomes include the need for additional uterotonics, surgical interventions, blood transfusions, and adverse drug effects. Participants will be selected based on strict inclusion and exclusion criteria to ensure uniformity. Randomization will be done using permuted blocks and allocation concealed in sealed envelopes. Hemoglobin levels will be assessed pre- and post-operatively to evaluate blood loss impact. Data will be analyzed using Stata 18, applying appropriate statistical tests for continuous and categorical variables. The study seeks to generate evidence on which uterotonic agent offers superior efficacy and safety in PPH prevention. Results will inform clinical practice in obstetric care during cesarean deliveries. |