Hemodynamic effects of Carbetocin and Oxytocin given as an intravenous bolus in a women undergoing caesarean delivery: A randomised trail
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
Syeda Kubra
Bangalore medical college and research institute
