Oxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections
NCT03651882 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 550
Last updated 2023-05-24
Summary
Objective is to proof non-inferiority of intramyometrial and intravenous oxytocin application compared to intravenous carbetocin for prevention of postpartum hemorrhage in planned, uncomplicated cesarean deliveries.
Conditions
- Postpartum Hemorrhage
Interventions
- DRUG
-
Oxytocin
Oxytocin given in a combined regimen: after delivery 10 IE of oxytocin are applied intramyometrially and 10 IE of oxytocin are given over an infusion of 1000ml of 0.9% NaCL over 12 hours intravenously.
- DRUG
-
Carbetocin
Carbetocin is given 0.1mg intravenously as a bolus after delivery.
Sponsors & Collaborators
-
University of Zurich
lead OTHER
Principal Investigators
-
Christian Haslinger, M.D. · University of Zurich
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-08-07
- Primary Completion
- 2022-01-10
- Completion
- 2022-01-10
Countries
- Switzerland
Study Locations
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