| CTRI Number |
CTRI/2025/07/090836 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Optimum dose of carbetocin needed for adequate contraction of uterus during cesarean section in patients with preterm pregnancy (less than 37 weeks) and completed term pregnancy (37 weeks or more). |
|
Scientific Title of Study
|
Minimum effective dose of carbetocin for preventing uterine atony during cesarean delivery:Comparison between patients with preterm versus term pregnancy. |
| 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 Asha Tyagi |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,UCMS and GTB Hospital,Dilshad Garden,Shahadra
New Delhi
DELHI
110095
India |
| Phone |
01122692415 |
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha Tyagi |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,UCMS and GTB Hospital,Dilshad Garden,Shahadra
New Delhi
DELHI
110095
India |
| Phone |
01122692415 |
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Patel |
| Designation |
Post Graduate Resident 1st Year |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,UCMS and GTB Hospital,Dilshad Garden,Shahadra
New Delhi
DELHI
110095
India |
| Phone |
6261745463 |
| Fax |
|
| Email |
pinki8380@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and GTB Hospital |
| Address |
Dilshad Garden,Shahdra,Delhi, India-110095. |
| 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 Priyanka Patel |
University College of Medical Sciences and GTB Hospital |
Anaesthesia office, 2nd floor, OT block, Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahdra
East
DELHI |
6261745463
pinki8380@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research (IEC-HR), University College of Medical Sciences, University of Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carbetocin injection in pregnant patients with completed 37 weeks gestation. |
Injected intravenously to mother, over 30 seconds to 1 minute, at time of fetal delivery, during cesarean section using spinal block (dose will be between 20-140 ug depending on sequential allocation method). |
| Intervention |
Carbetocin injection in pregnant patients with less than 37 weeks gestation. |
Injected intravenously over 30 seconds to 1 minute, to mother at time of fetal delivery, during cesarean section using spinal block (dose will be between 20-140 ug depending on sequential allocation method). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Posted for cesarean delivery under spinal block, either into the term (completed 37 weeks) or preterm (less than 37 weeks) cohort |
|
| ExclusionCriteria |
| Details |
Patients in labor, receiving preoperative oxytocin or megnesium sulfate therapy,with coagulopathy, history of previous uterine atony or postpartum hemorrhage or bleeding disorder or heart disease will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The ED90 dose (dose effective in 90% population) for satisfactory uterine tone as judged by the obstetrician |
From 2 minutes after carbetocin to end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Carbetocin associated side effects like hypotension, tachycardia |
From administration of carbetocin to 10 minutes later. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/07/2025 |
| 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="4"
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
|
Aim: To evaluate and compare the optimal dose of carbetocin for preventing uterine atony during cesarean delivery in patients with preterm versus term pregnancy. Objective: To evaluate and compare during cesarean delivery in patients with preterm and term pregnancy, the minimum effective dose (defined as ED90 i.e., dose expected to be adequate in 90% of target population) of carbetocin for achieving and maintaining adequate uterine tone.
The bolus dose of carbetocin will be injected over 30 seconds to 1 min immediately after delivery of fetal head. The dose will be 20 mic for the first patient in both cohorts. The dose in subsequent cases for either cohort will be determined by the response to the bolus in previous patient of the particular cohort. After a “failed” dose of carbetocin bolus, the subsequent patient of the group will receive amount greater by 10 mic. In case of a “successful” dose, it will be decreased by 10 mic with a probability of 1/9; otherwise it will remain unchanged. This method of biased-coin allocation method with a probability of 1/9 after a successful dose will be implemented by drawing chits out of an opaque bag. While 9/10 of the chits will read for “same dose” to be repeated, 1/10 will instruct for a “decrease in dose”. The instruction on the randomly pulled out chit will be followed. Determinant of a successful dose will be a satisfactory uterine tone at time of first assessment (2 min after carbetocin) along with no request of any additional uterotonic by obstetrician intraoperatively. Additional uterotonic will be given on request of obstetrician at any time after 2 minutes of carbetocin injection Statistical analysis: The primary outcome i.e., the ED90 of carbetocin will be calculated using dose-response data for each group by applying log-logistic regression with bootstrapping. |