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

May 23, 2023 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

550

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin
Drug: 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.
Active Comparator: Carbetocin
Drug: Carbetocin
Carbetocin is given 0.1mg intravenously as a bolus after delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of women with a delta hemoglobin ≥ 30g/l.
Time Frame: 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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse maternal outcome parameters
Time Frame: 15 days
decrease in hemoglobin (delta hemoglobin, in g/l)
15 days
adverse maternal outcome parameters
Time Frame: 15 days
estimated blood loss (in mL),
15 days
adverse maternal outcome parameters
Time Frame: 15 days
incidence of PPH (in %)
15 days
adverse maternal outcome parameters
Time Frame: 15 days
use of additional uterotonic agents (prostaglandines)
15 days
adverse maternal outcome parameters
Time Frame: 15 days
blood transfusion (number of packed red cells)
15 days
adverse maternal outcome parameters
Time Frame: 15-300 minutes
length of surgery (in minutes)
15-300 minutes
adverse maternal outcome parameters
Time Frame: 15 days
number of patients with revision (second surgery in the 24hours following the primary cesarean section)
15 days
adverse maternal outcome parameters
Time Frame: 15 days
admission to an intensive care unit (%)
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Study Chair: Christian Haslinger, M.D., University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2018

Primary Completion (Actual)

January 10, 2022

Study Completion (Actual)

January 10, 2022

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC-Nr: 2017-01750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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