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Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published.
We hypothesize that a dose-response study will establish the minimum dose of carbetocin required to produce appropriate contractility in 95% of the women (ED95) undergoing elective cesarean delivery.
The Society of Obstetricians and Gynecologists of Canada (SOGC)recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery. However, a dose response study to determine the minimum effective dose of carbetocin has not yet been published.
Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effects profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin.
The results of this study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbetocin 80mcg | Active Comparator |
| |
| Carbetocin 90mcg | Active Comparator |
| |
| Carbetocin 100mcg | Active Comparator |
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| Carbetocin 110mcg | Active Comparator |
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| Carbetocin 120mcg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbetocin | Drug | 80mcg carbetocin, IV, over 1 minute following delivery of the fetal head. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uterine tone. | The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy). | 2 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine tone | Uterine tone will be assessed by palpation 2 hours post-delivery by the nurse/obstetrician in the recovery room. | 2 hours |
| Blood loss | Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean section. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose CA Carvalho, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G1X5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22717890 | Derived | Cordovani D, Balki M, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose. Can J Anaesth. 2012 Aug;59(8):751-7. doi: 10.1007/s12630-012-9728-2. Epub 2012 Jun 21. |
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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 |
|---|---|
| C020731 | carbetocin |
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| Carbetocin | Drug | 90mcg carbetocin, IV, over 1 minute following delivery of the fetal head. |
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| Carbetocin | Drug | 100mcg carbetocin, IV, over 1 minute following delivery of the fetal head. |
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| Carbetocin | Drug | 110mcg carbetocin, IV, over 1 minute following delivery of the fetal head. |
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| Carbetocin | Drug | 120mcg carbetocin, IV, over 1 minute following delivery of the fetal head. |
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| 48 hours |
| Side effects | Any of the following will be noted up to 2 hours post delivery: systolic blood pressure < 80% of pre-delivery values, tachycardia > 30% pre-delivery levels, bradycardia < 30% pre-delivery levels, other dysrhythmias, nausea, vomiting, chest pain, shortness of breath, headache, flushing, others | 2 hours |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |