| CTRI Number |
CTRI/2025/12/099727 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Carbetocin and Oxytocin on Blood Pressure and Heart Rate in Women Undergoing Planned Caesarean Section |
|
Scientific Title of Study
|
Comparison of intravenous carbetocin versus oxytocin infusion on hemodynamics in women undergoing elective Caesarean section in a tertiary care hospital: A prospective observational 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 Greeshma Jose |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology,
Kasturba Medical College and Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7034694040 |
| Fax |
|
| Email |
greeshma.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Priyanka G Kini |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology,
Kasturba Medical College and Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845801588 |
| Fax |
|
| Email |
priyanka.kini@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Greeshma Jose |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology,
Kasturba Medical College and Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7034694040 |
| Fax |
|
| Email |
greeshma.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal
Manipal Academy of Higher Education
576104
Udupi, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College and Kasturba Hospital |
| Address |
Manipal Academy of Higher Education
576104, Udupi, Karnataka, India |
| 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 |
| DrGreeshma Jose |
Kasturba Medical College and Kasturba Hospital, Manipal |
Department of Anaesthesiology and Department of Obstetrics and Gynaecology
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
7034694040
greeshma.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
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 Group |
IV Carbetocin 100 mcg bolus over 1 minute |
| Comparator Agent |
Oxytocin Group |
IV Oxytocin 15 lU infusion over 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA Physical Status I and II
2. Singleton pregnancy (after 37 weeks)
3. No history of hypertensive disorders or cardiovascular disease |
|
| ExclusionCriteria |
| Details |
1. Preeclampsia or eclampsia
2. Known hypersensitivity to oxytocin or carbetocin
3. Multiple gestations
4. Placental abnormalities (placenta previa, placental abruption)
5. Severe anemia (Hb less than 7 gram percent)
6. Contraindications to spinal anesthesia (patient refusal, raised intracranial pressure, infection at the site of administration, hypersensitivity to local anaesthetic, coagulopathy, sepsis,
uncorrected hypovolemia) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic effects (blood pressure, heart rate, and oxygen saturation) of intravenous oxytocin and carbetocin in patients undergoing cesarean section under spinal anesthesia. |
After delivery of the baby and clamping of the umbilical cord, patients will receive either oxytocin or carbetocin. Every 5 minutes for the first 30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the incidence of severe hypotension requiring vasopressor intervention.
2. To evaluate the need for additional uterotonic agents.
3. To analyze the frequency of adverse effects such as nausea, vomiting, dizziness, and chest
discomfort.
4. To observe uterine tone response and blood loss estimation intraoperatively. |
Intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/01/2026 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
Postpartum hemorrhage (PPH) remains a major cause of maternal morbidity and mortality worldwide. Active management of the third stage of labor (AMTSL) with uterotonic agents such as oxytocin is the standard of care. Carbetocin, a long acting oxytocin analog, has emerged as an alternative with potential benefits, including a longer duration of action and reduced need for additional uterotonic doses.
Spinal anaesthesia, the preferred anaesthetic technique for caesarean sections, induces sympathetic blockade, leading to vasodilation and hypotension. The additional hemodynamic effects of uterotonics, such as tachycardia and hypotension, may further compromise maternal stability. However, there is limited evidence comparing the hemodynamic profiles of oxytocin and carbetocin when administered as intravenous boluses during caesarean section under spinal anaesthesia.
While oxytocin remains as the first line uterotonic agent, its administration can lead to significant hemodynamic disturbances. Carbetocin, due to its prolonged action, may reduce the need for repeated doses and the associated cardiovascular instability. A comparative evaluation of these two drugs in context of spinal anaesthesia is essential to determine the safer option in clinical practice. |