Back to resultsOxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Oxytocin
Carbetocin
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oxytocin
Carbetocin
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
adverse maternal outcome parameters
decrease in hemoglobin (delta hemoglobin, in g/l)
adverse maternal outcome parameters
estimated blood loss (in mL),
adverse maternal outcome parameters
incidence of PPH (in %)
adverse maternal outcome parameters
use of additional uterotonic agents (prostaglandines)
adverse maternal outcome parameters
blood transfusion (number of packed red cells)
adverse maternal outcome parameters
length of surgery (in minutes)
adverse maternal outcome parameters
number of patients with revision (second surgery in the 24hours following the primary cesarean section)
adverse maternal outcome parameters
admission to an intensive care unit (%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03651882
Brief Title
Oxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections
Official Title
Intramyometrial and Intravenous Oxytocin Compared to Intravenous Carbetocin for Prevention of Postpartum Hemorrhage in Elective Cesarean Sections - a Monocentric Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Before c-section the patients will be randomized to the oxytocin or the carbetocin group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Title
Carbetocin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
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
Intervention Name(s)
Carbetocin
Intervention Description
Carbetocin is given 0.1mg intravenously as a bolus after delivery.
Primary Outcome Measure Information:
Title
incidence of women with a delta hemoglobin ≥ 30g/l.
Description
Delta hemoglobin is defined as the difference of the hemoglobin at admission minus the hemoglobin after delivery, usually 24-48 hours after the delivery.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
adverse maternal outcome parameters
Description
decrease in hemoglobin (delta hemoglobin, in g/l)
Time Frame
15 days
Title
adverse maternal outcome parameters
Description
estimated blood loss (in mL),
Time Frame
15 days
Title
adverse maternal outcome parameters
Description
incidence of PPH (in %)
Time Frame
15 days
Title
adverse maternal outcome parameters
Description
use of additional uterotonic agents (prostaglandines)
Time Frame
15 days
Title
adverse maternal outcome parameters
Description
blood transfusion (number of packed red cells)
Time Frame
15 days
Title
adverse maternal outcome parameters
Description
length of surgery (in minutes)
Time Frame
15-300 minutes
Title
adverse maternal outcome parameters
Description
number of patients with revision (second surgery in the 24hours following the primary cesarean section)
Time Frame
15 days
Title
adverse maternal outcome parameters
Description
admission to an intensive care unit (%)
Time Frame
15 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Haslinger, M.D.
Organizational Affiliation
University of Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Oxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections
We'll reach out to this number within 24 hrs