search
Back to results

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

Primary Purpose

Uterine Atony, Post-partum Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Carbetocin
Carbetocin
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Atony focused on measuring Carbetocin, Uterotonic drug, elective cesarean section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Saint-François-d'Assise (CHUQ)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Carbetocin 100 mcg

Carbetocin 50 mcg

Arm Description

Outcomes

Primary Outcome Measures

Utilization of a second uterotonic drug

Secondary Outcome Measures

Incidence of side effects
Incidence of major complications
Drop in hemoglobin measurement

Full Information

First Posted
May 17, 2012
Last Updated
May 27, 2013
Sponsor
Laval University
search

1. Study Identification

Unique Protocol Identification Number
NCT01630187
Brief Title
Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section
Official Title
Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Atony, Post-partum Hemorrhage
Keywords
Carbetocin, Uterotonic drug, elective cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbetocin 100 mcg
Arm Type
Active Comparator
Arm Title
Carbetocin 50 mcg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Intervention Description
Administration of carbetocin 50 mcg , after clamping the umbilical cord
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Intervention Description
Administration of carbetocin 100 mcg , after clamping the umbilical cord
Primary Outcome Measure Information:
Title
Utilization of a second uterotonic drug
Time Frame
First 48 hours of the postpartum
Secondary Outcome Measure Information:
Title
Incidence of side effects
Time Frame
During the fifteen minutes following the administration of carbetocin
Title
Incidence of major complications
Time Frame
First 48 hours of the postpartum
Title
Drop in hemoglobin measurement
Time Frame
on the second post-partum day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Bédard
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint-François-d'Assise (CHUQ)
City
Quebec
ZIP/Postal Code
G1L 3L5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs