Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial

Conditions
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Uterine Atony, Post-partum Hemorrhage

Intervention / Treatment
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* Drug: Carbetocin
* Drug: Carbetocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years old ≥ 37-week pregnancy singleton pregnancy elective cesarean section with a low transverse incision ASA I or II Exclusion Criteria: Personal history of uterine atony or postpartum hemorrhage Abnormal placental implantation (known or suspected) > 3 cesarean sections in the past Personal history of a classic uterine incision Estimated fetal weight > 4500g Hemoglobin < 100 g/L Regular use of tocolytic drugs Cesarean section under general anesthesia Known allergy to carbetocin Refusal Inability to obtain informed consent

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carbetocin 100 mcg<br> | Drug: Carbetocin<br>* Administration of carbetocin 100 mcg , after clamping the umbilical cord<br>|
| Experimental: Carbetocin 50 mcg<br> | Drug: Carbetocin<br>* Administration of carbetocin 50 mcg , after clamping the umbilical cord<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization of a second uterotonic drug |  | First 48 hours of the postpartum | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Drop in hemoglobin measurement |  | on the second post-partum day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbetocin, Uterotonic drug, elective cesarean section