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The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.
Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.
Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbetocin 100 mcg | Active Comparator |
| |
| Carbetocin 50 mcg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbetocin | Drug | Administration of carbetocin 50 mcg , after clamping the umbilical cord |
|
| Measure | Description | Time Frame |
|---|---|---|
| Utilization of a second uterotonic drug | First 48 hours of the postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of side effects | During the fifteen minutes following the administration of carbetocin | |
| Incidence of major complications | First 48 hours of the postpartum | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Bédard | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint-François-d'Assise (CHUQ) | Québec | Quebec | G1L 3L5 | Canada |
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| ID | Term |
|---|---|
| D014593 | Uterine Inertia |
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D004420 | Dystocia |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C020731 | carbetocin |
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| Carbetocin | Drug | Administration of carbetocin 100 mcg , after clamping the umbilical cord |
|
| Drop in hemoglobin measurement |
| on the second post-partum day |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |