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

Uterine Atony Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630187
• Other study ID #: CARB-011
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2012
• Last updated: May 27, 2013
• Start date: April 2012
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-partum Hemorrhage
• Postpartum Hemorrhage
• Uterine Atony
• Uterine Inertia

Intervention

Drug:
• Carbetocin
Administration of carbetocin 50 mcg , after clamping the umbilical cord
• Carbetocin
Administration of carbetocin 100 mcg , after clamping the umbilical cord

Locations

Country	Name	City	State
Canada	Hôpital Saint-François-d'Assise (CHUQ)	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utilization of a second uterotonic drug		First 48 hours of the postpartum	No
Secondary	Incidence of side effects		During the fifteen minutes following the administration of carbetocin	No
Secondary	Incidence of major complications		First 48 hours of the postpartum	No
Secondary	Drop in hemoglobin measurement		on the second post-partum day	No