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Clinical trial

Intramyometrial and Intravenous Oxytocin Compared to Intravenous Carbetocin for Prevention of Postpartum Hemorrhage in Elective Cesarean Sections - a Monocentric Randomized Controlled Study

ID
Name
BASEC-Nr: 2017-01750
Description
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.
Trial arms
Trial start
2018-08-07
Estimated PCD
2022-01-10
Trial end
2022-01-10
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Oxytocin
Carbetocin
Carbetocin is given 0.1mg intravenously as a bolus after delivery.
Arms:
Carbetocin
Size
550
Primary endpoint
incidence of women with a delta hemoglobin ≥ 30g/l.
48 hours
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Before c-section the patients will be randomized to the oxytocin or the carbetocin group.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 550, 'type': 'ACTUAL'}}
Updated at
2023-05-24

1 organization

2 products

1 indication

Organization
University of Zurich
Product
Oxytocin
Indication
Postpartum Hemorrhage
Product
Carbetocin