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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651882
• Other study ID #: BASEC-Nr: 2017-01750
• Status: Completed
• Phase: Phase 4
• Start date: August 7, 2018
• Est. completion date: January 10, 2022

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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