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

Phase 4

Completed

• Conditions: Uterine Atony; Post-partum Hemorrhage
• Interventions: Drug: Carbetocin

• Registration Number: NCT01630187
• Lead Sponsor: Laval University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-28
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-27
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbetocin 50 mcg	Carbetocin	-
Carbetocin 100 mcg	Carbetocin	-

Primary Outcome Measures

Name	Time	Method
Utilization of a second uterotonic drug	First 48 hours of the postpartum

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Saint-François-d'Assise (CHUQ); 🇨🇦 Quebec, Canada