| CTRI Number |
CTRI/2024/03/064265 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects on vital parameters of drugs that stimulate uterine contractions like Oxytocin and carbetocin given as a bolus in a women undergoing caesarean delivery |
|
Scientific Title of Study
|
Hemodynamic effects of Carbetocin and Oxytocin given as an intravenous bolus in a women undergoing caesarean delivery: A randomised trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syeda Kubra |
| Designation |
Postgraduate Resident |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anaesthesiology, Bangalore medical college and research institute Bangalore medical college and research institute KR road Fort Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
8147515051 |
| Fax |
|
| Email |
syedakubra1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tulsi T |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
3rd floor Vani Vilas hospital
Department of Anaesthesiology Bangalore medical college and research institute Bangalore medical college and research institute KR road Fort Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9483188870 |
| Fax |
|
| Email |
drtulsikeshav1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tulsi T |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anaesthesiology Bangalore medical college and research institute Bangalore medical college and research institute KR road Fort Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9483188870 |
| Fax |
|
| Email |
drtulsikeshav1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vani Vilas hospital room 3rd floor elective operation theatre Department of Anaesthesiology Bangalore medical college and research
institute K R road Fort Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research institute |
| Address |
Bangalore medical college and research institute, KR road, Fort, Bangalore-560002 |
| 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 Tulsi T |
Bangalore medical college and research institute |
Vani Vilas hospital 3rd floor elective operation theatre Department of Anaesthesiology Bangalore medical college and research institute KR road
Fort Bangalore 560002
Bangalore
KARNATAKA |
9483188870
drtulsikeshav1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
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
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Carbetocin |
Injection carbetocin 100mcg intravenously
|
| Comparator Agent |
Oxytocin |
Injection Oxytocin 5U intravenously |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Parturients who are willing to give informed written consent
2. Parturients of all age groups
3. Parturients who are ASA grade 2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of maternal heart rate |
To assess after 1,3,5,7,10 minutes after administration of the drugs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of other hemodynamic parameters like SBP, DBP and MAP |
To assess after 1,3,5,7,10 minutes after administration of the drugs |
|
|
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
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
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) is a potentially life threatening complication of both vaginal and caesarean delivery. The prevalence of PPH is approximately 6% of all the deliveries. The most frequent cause of PPH is uterine atony. Surprisingly the incidence has increased in recent years even in some of the developed countries. Therefore active management of third stage of labor rather than expectant management is recommended. Currently intravenous injection of 5U of Oxytocin is recommended as the prophylactic medication of choice to reduce the incidence and severity of PPH. Oxytocin has a short half-life with t 1/2 of 6mins. Hemodynamic effects of an oxytocin bolus consists of systemic vasodilation with hypotension , tachycardia and increase in cardiac output. Carbetocin a synthetic analogue of oxytocin with a longer half-life of approximately 40mis, exerts it’s effects via the same molecular mechanisms as oxytocin, and has been reported to decrease the use of additional oxytocics. Unlike oxytocin, carbetocin is a heat-stable drug and does not require cold chain transport and storage. |