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

NCT03651882 | Completed Phase 4 DMC

• 1 other identifier: BASEC-Nr: 2017-01750
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• incidence of women with a delta hemoglobin ≥ 30g/l.

  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 Outcomes (8)

• adverse maternal outcome parameters

  15 days

• adverse maternal outcome parameters

  15 days

• adverse maternal outcome parameters

  15 days

• adverse maternal outcome parameters

  15 days

• adverse maternal outcome parameters

  15 days

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Drug: Oxytocin

Carbetocin

ACTIVE COMPARATOR

Drug: Carbetocin

Interventions

Oxytocin 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.

Oxytocin

Carbetocin DRUG

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

Carbetocin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective cesarean section
• present informed consent
• completed 36 weeks of gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Christian Haslinger, M.D.

  University of Zurich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 29, 2018
• Study Start: August 7, 2018
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

CH (1)