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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Postpartum Hemorrhage

Treatments: Drug: Carbetocin; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT03651882

BASEC-Nr: 2017-01750

Details and patient eligibility

About

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.

Enrollment: 550 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

Oxytocin

Active Comparator group

Treatment:

Drug: Oxytocin

Carbetocin

Active Comparator group

Treatment:

Drug: Carbetocin