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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Active Comparator |
| |
| Carbetocin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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), |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Haslinger, M.D. | University of Zurich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| C020731 | carbetocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Before c-section the patients will be randomized to the oxytocin or the carbetocin group.
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| Carbetocin | Drug | Carbetocin is given 0.1mg intravenously as a bolus after delivery. |
|
| 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 |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |