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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03651882

Enrollment

550

Registered

2018-08-29

Start date

2018-08-07

Completion date

2022-01-10

Last updated

2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

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.

Interventions

DRUGOxytocin

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.

DRUGCarbetocin

Carbetocin is given 0.1mg intravenously as a bolus after delivery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Before c-section the patients will be randomized to the oxytocin or the carbetocin group.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
adverse maternal outcome parameters	15 days	decrease in hemoglobin (delta hemoglobin, in g/l)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026