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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Carbetocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Before c-section the patients will be randomized to the oxytocin or the carbetocin group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br> | Drug: Oxytocin<br>* 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.<br>|
| Active Comparator: Carbetocin<br> | Drug: Carbetocin<br>* Carbetocin is given 0.1mg intravenously as a bolus after delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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