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Clinical Trials/CTRI/2024/03/064265
CTRI/2024/03/064265Not yet recruitingPhase 2

Hemodynamic effects of Carbetocin and Oxytocin given as an intravenous bolus in a women undergoing caesarean delivery: A randomised trail

Bangalore medical college and research institute1 site in 1 country60 target enrollmentStarted: March 26, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Comparison of maternal heart rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
15.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 1.Parturients who are willing to give informed written consent
  • Parturients of all age groups 3.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Comparison of maternal heart rate

Time Frame: To assess after 1,3,5,7,10 minutes after administration of the drugs

Secondary Outcomes

  • Comparison of other hemodynamic parameters like SBP, DBP and MAP(To assess after 1,3,5,7,10 minutes after administration of the drugs)

Investigators

Sponsor
Bangalore medical college and research institute
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Syeda Kubra

Bangalore medical college and research institute

Study Sites (1)

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