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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
550
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 is given 0.1mg intravenously as a bolus after delivery.
University Hospital Zurich
Zurich, Switzerland
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.
Time frame: 48 hours
adverse maternal outcome parameters
decrease in hemoglobin (delta hemoglobin, in g/l)
Time frame: 15 days
adverse maternal outcome parameters
estimated blood loss (in mL),
Time frame: 15 days
adverse maternal outcome parameters
incidence of PPH (in %)
Time frame: 15 days
adverse maternal outcome parameters
use of additional uterotonic agents (prostaglandines)
Time frame: 15 days
adverse maternal outcome parameters
blood transfusion (number of packed red cells)
Time frame: 15 days
adverse maternal outcome parameters
length of surgery (in minutes)
Time frame: 15-300 minutes
adverse maternal outcome parameters
number of patients with revision (second surgery in the 24hours following the primary cesarean section)
Time frame: 15 days
adverse maternal outcome parameters
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
admission to an intensive care unit (%)
Time frame: 15 days