| CTRI Number |
CTRI/2025/11/097261 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO ASSESS THE EFFECTS OF CARBETOCIN VERSUS OXYTOCIN ON UTERUS IN A CESAREAN SECTION WITH A HIGH RISK OF POST PARTUM HEMORRHAGE |
|
Scientific Title of Study
|
TO ASSESS TO UTEROSTONIC EFFECTS OF CARBETOCIN VERSUS OXYTOCIN IN A CESAREAN SECTION WITH A HIGH RISK OF POST PARTUM HEMORRHAGE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GAURI GOYAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DR RAM PRAKASH GUPTA MEMORIAL MOTHER AND CHILD REFRRAL HOSPITAL, AMAR SHAHEED PATH, GOMTI NAGAR, DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, LUCKNOW
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9760253014 |
| Fax |
|
| Email |
gaurigoyal2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Malvika Mishra |
| Designation |
Professor Junior Grade(thesis guide) |
| Affiliation |
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DR RAM PRAKASH GUPTA MEMORIAL MOTHER AND CHILD REFRRAL HOSPITAL, AMAR SHAHEED PATH, GOMTI NAGAR, DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, LUCKNOW
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9935595430 |
| Fax |
|
| Email |
drmalvikam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GAURI GOYAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DR RAM PRAKASH GUPTA MEMORIAL MOTHER AND CHILD REFRRAL HOSPITAL, AMAR SHAHEED PATH, GOMTI NAGAR, DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, LUCKNOW
UTTAR PRADESH
226002
India |
| Phone |
9760253014 |
| Fax |
|
| Email |
gaurigoyal2013@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR GAURI GOYAL |
| Address |
DR RAM PRAKASH GUPTA MEMORIAL MOTHER AND CHILD REFRRAL HOSPITAL, AMAR SHAHEED PATH, GOMTI NAGAR, DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, LUCKNOW |
| 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 |
| DR GAURI GOYAL |
Dr Ram Prakash Gupta Mother And Child Referral Hospital, DrRMLIMS |
Department of obstetrics and gynaecology,DR RPGMCRH, AMAR SHAHEED PATH, near dial100 police office, GOMTI NAGAR, LUCKNOW
Lucknow
UTTAR PRADESH |
9760253014
gaurigoyal2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DrRMLIMS Institutional ethics committtee |
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 |
100 µg of intravenous carbetocin as a single bolus at the delivery of the anterior shoulder |
| Comparator Agent |
oxytocin |
20 IU of oxytocin diluted in 1000 mL of 0.9% sodium chloride solution, infused at a rate of 150 mL per hour starting at the time of shoulder delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
•Women scheduled for cesarean section who are willing to participate.
•Presence of maternal risk factors for PPH, such as:
1- Multifetal pregnancy
2- Previous cesarean section
3- Elderly gravida
4- Multiparpus female
5-Uterine fibroids, myomectomy history, or placenta previa, placenta accreta spectrum
6-Past history of postpartum hemorrhage
7-Presence of fetal risk factors, including macrosomia or polyhydramnios-associated malformations.(related with uterine overdistension)
8-IVF conceived pregnancy
•Hypertension or preeclampsia
|
|
| ExclusionCriteria |
| Details |
•Women giving negative consent to participate in study
•women with Cardiac, renal, or hepatic disease
•Epilepsy
•Hypersensitivity to carbetocin (as per British National Formulary)
•Undergo general anesthesia for the cesarean section
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uterotonic effect: post partum hemorrheage rate (i.e. number of women who experience postpartunm hemorrhage even after drug administration ) after drug administration |
Uterotonic effect: post partum hemorrheage rate (i.e. number of women who experience postpartunm hemorrhage even after drug administration ) after drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic Effects: Changes in systolic & diastolic blood pressure at: Baseline (after CSE anesthesia), 1, 3, & 5, 10 & 60 minutes after drug administration,
|
1 hour |
estimated Blood Loss: Intraoperative & immediate postoperative blood loss estimation
|
1 day |
Need for Additional Uterotonics: Proportion of women requiring additional uterotonic agents (e.g., methylergometrine, misoprost, carboprost)
|
|
Hemoglobin Drop: Change in hemoglobin levels: Preoperative, 2 hours postoperative, 24 hours postoperative
|
1 day |
Adverse Effects: Incidence of Postop Nausea and Vomiting, Flushing, Headache, Dyspnea
|
|
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
02/02/2026 |
| 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) |
Open to Recruitment |
|
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
|
a prospective comparative observational study To Assess The Uterotonic Effects Of
Carbetocin Versus Oxytocin In A Cesarean Section With A High Risk Of
Postpartum Hemorrhage in 188 patients. participants will be
consecutively allocated into two groups based on the uterotonic agent received:
Group A(UNIT IIIA- UNDER DR NAMITA DOHAREY) will consist of women
who will be administered 100 µg of intravenous carbetocin as a single bolus at
the delivery of the anterior shoulder, while Group B(UNIT IIIB- UNDER DR
VISHI) will include women who will receive 20 IU of oxytocin diluted in
1000 mL of 0.9% sodium chloride solution, infused at a rate of 150 mL per hour
starting at the same time point. primary outcome will be to measure post partum
hemorrheage rate (i.e. number of women who experience postpartunm
hemorrhage even after drug administration ) after drug administration and secondary outcomes will be Hemodynamic
Effects: Changes in systolic and diastolic blood pressure at: Baseline (after
CSE anesthesia), 1, 3, and 5, 10 and 60 minutes after drug administration, Estimated Blood
Loss: Intraoperative and immediate postoperative blood loss estimation, Need for
Additional Uterotonics: Proportion of women requiring additional uterotonic
agents (e.g., methylergometrine, misoprost, carboprost), Hemoglobin Drop:
Change in hemoglobin levels: Preoperative, 2 hours postoperative, 24 hours
postoperative and Adverse Effects:
Incidence of Postop Nausea and Vomiting, Flushing, Headache, Dyspnea |