Oxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections

Phase 4

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Oxytocin; Drug: Carbetocin

• Registration Number: NCT03651882
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-24
• Study Start: 2018-08-07
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-29
• Primary Completion: 2022-01-10
• Study Completion: 2022-01-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 550

Inclusion Criteria

• elective cesarean section
• present informed consent
• completed 36 weeks of gestation

Exclusion Criteria

• need for intubation (carbetocin is only licensed for epidural or spinal anesthesia)
• multiple fetus pregnancy
• known coagulopathy
• Placenta praevia
• morbidly adherent placenta
• placental abruption
• thrombocyte dysfunction
• HELLP-syndrome
• preeclampsia
• history of uterine atony

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin	Oxytocin	-
Carbetocin	Carbetocin	-

Primary Outcome Measures

Name	Time	Method
incidence of women with a delta hemoglobin ≥ 30g/l.	48 hours	Delta hemoglobin is defined as the difference of the hemoglobin at admission minus the hemoglobin after delivery, usually 24-48 hours after the delivery.

Secondary Outcome Measures

Name	Time	Method
adverse maternal outcome parameters	15 days	admission to an intensive care unit (%)

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Switzerland