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

May 27, 2013 updated by: Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1L 3L5
        • Hôpital Saint-François-d'Assise (CHUQ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Utilization of a second uterotonic drug
Time Frame: First 48 hours of the postpartum
First 48 hours of the postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of side effects
Time Frame: During the fifteen minutes following the administration of carbetocin
During the fifteen minutes following the administration of carbetocin
Incidence of major complications
Time Frame: First 48 hours of the postpartum
First 48 hours of the postpartum
Drop in hemoglobin measurement
Time Frame: on the second post-partum day
on the second post-partum day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Julie Bédard, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 27, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARB-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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