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

NCT ID: NCT03651882

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-07

Study Completion Date

2022-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oxytocin

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

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.

Carbetocin

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Carbetocin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Haslinger, M.D.

Role: STUDY_CHAIR

University of Zurich

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BASEC-Nr: 2017-01750

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oxytocin in Cesarean Delivery
NCT01236482 UNKNOWN PHASE4