| CTRI Number |
CTRI/2025/02/080073 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare results of bleeding post delivery between pregnant ladies administered carbetocin or oxytocin undergoing elective Caesarian section |
|
Scientific Title of Study
|
Carbetocin Versus Oxytocin in Caesarean Section: A Comparative study |
| 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 Anirudh Sood |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Women and Child Health Block, Dept. of OBG, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8890620190 |
| Fax |
|
| Email |
anirudhme2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothi Shetty |
| Designation |
Professor and Head of Unit OBG |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Women and Child Health Block, Dept. of OBG, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
0 |
| Fax |
|
| Email |
jthshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anirudh Sood |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College |
| Address |
Women and Child Health Block, Dept. of OBG, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8890620190 |
| Fax |
|
| Email |
anirudhme2016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of OBG, KMC Manipal , Manipal karnatak 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Anirudh Sood |
| Address |
Women and Child Health Block, Dept. of OBG, KMC Manipal , Manipal Karnataka 576104 |
| Type of Sponsor |
Private 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 Anirudh Sood |
Kasturba Medical college and Hospital |
Dept of OBG, KMC Manipal
Udupi
KARNATAKA |
8890620190
anirudhme2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Kasturba Medical College, Manipal. 576104 |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Previous Caesarean Delivery
2 Fetal Macrosomia
3 Malpresentation |
|
| ExclusionCriteria |
| Details |
1 Multiple gestation
2 Placenta previa and placental abruption
3 Uterine fibroids
4 Bronchial asthma
5 Cardiac disease
6 Epilepsy
Hypertension
Liver, renal or endocrine disease
Women with hypersensitivity to carbetocin |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate the proportion of women in each group with need of additional uterotonics within 24 hours of delivery |
24 hours post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Estimated blood loss, difference in preop & post Hemoglobin ,vitals ,signs during & after the operation, uterine tone & uterine contractility |
24 hours before delivery & 24 hours post delivery |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
17/02/2025 |
| 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
|
The theme of the study is to compare the effectiveness of carbetocin vs oxytocin as a uterotonic in preventing PPH post caesarean delivery. The primary outcome is to calculate the proportion of women in each group with need of additional uterotonics. The secondary outcomes are to measure estimated blood loss, difference in preop and post Hemoglobin. vitals gins during and after the operation, uterine tone and uterine contractility. If the efficacy of Carbetocin is proven over Oxytocin as a superior uterotonic, Carbetocin can be drug of choice for prevention and control of PPH hence impacting the Maternal Mortality rate and the reduction of maternal deaths in India. Current studies have been ineffective in comparing the efficacy of both drugs hence further studies are needed to compare the efficacy of both drugs as uterotonics in preventing PPH after caesarean delivery. |