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

NCT ID: NCT01630187

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-07-31

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.

Conditions

Uterine Atony; Post-partum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Carbetocin 100 mcg

Group Type: ACTIVE_COMPARATOR

Carbetocin

Intervention Type: DRUG

Administration of carbetocin 100 mcg , after clamping the umbilical cord

Carbetocin 50 mcg

Group Type: EXPERIMENTAL

Carbetocin

Intervention Type: DRUG

Administration of carbetocin 50 mcg , after clamping the umbilical cord

Interventions

Carbetocin

Administration of carbetocin 50 mcg , after clamping the umbilical cord

Intervention Type: DRUG

Carbetocin

Administration of carbetocin 100 mcg , after clamping the umbilical cord

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Bédard

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Hôpital Saint-François-d'Assise (CHUQ)

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

CARB-011

Identifier Type: -

Identifier Source: org_study_id