ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery

February 12, 2013 updated by: Christian Loubert, Maisonneuve-Rosemont Hospital

ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery

The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide. Carbetocin have been shown effective in the prevention of uterine atony, which is the leading cause of postpartum hemorrhage. The Society of Obstetricians and Gynecologists of Canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to prevent postpartum hemorrhage. However, there is no clear data in the literature regarding the lowest effective dose of carbetocin that should be administered. The use of the minimum effective dose of carbetocin may reduce its side effects, including hypotension, tachycardia, nausea, vomiting and flushing.

In this trial, healthy term pregnant women undergoing elective cesarean delivery under spinal anesthesia will be recruited. The effective dose of carbetocin that will prevent postpartum uterine atony in 90% of the women (ED90) will be determined using a biased coin design up-down sequential allocation method. The determination of the carbetocin ED90 will help the anesthesiologist regarding the optimal dose of carbetocin to administer after elective cesarean delivery to prevent uterine atony.

Study Type

Interventional

Enrollment (Anticipated)

40

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
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Maisonneuve-Rosemont Hospital
        • Contact:
        • Contact:
          • Louis-Philippe Fortier, MD, FRCPC
          • Phone Number: 514.252.3426
          • Email: lpfortier@mac.com
        • Principal Investigator:
          • Christian Loubert, MD, FRCPC
        • Sub-Investigator:
          • Louis-Philippe Fortier, MD, FRCPC
        • Sub-Investigator:
          • Patrick Coursol-Provost, MD
        • Sub-Investigator:
          • Pierre Drolet, MD, FRCPC

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy pregnant women (ASA I or II)
  • Elective cesarean delivery
  • Spinal anesthesia
  • Term gestation (37 weeks and above)

Exclusion Criteria:

  • Multiple gestation
  • Known coagulopathy
  • Active labour
  • Uterine fibroids
  • Body mass index > 45
  • Emergency cesarean section
  • General anesthesia
  • Any contraindication to neuraxial anesthesia
  • Cardiopathies
  • Known allergies to carbetocin
  • Patient refusal
  • Placenta previa/Placenta accreta
  • Hypertensive disease/Preeclampsia/Eclampsia
  • Polyhydramnios
  • Previous history of uterine atony or postpartum hemorrhage
  • Renal or liver disease

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbetocin
Drug: Carbetocin
First patient: 70 mcg. Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg. An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change.
Other Names:
  • Duratocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of carbetocin which will prevent uterine atony in 90% of subjects
Time Frame: 5 minutes
The uterine tone will be assessed by the obstetrician by palpation 5 minutes after injection. The uterine tone will be judged either as satisfactory or unsatisfactory.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of side effects
Time Frame: 20 minutes
Any of these side effects will be noted in the first 20 minutes following injection of carbetocin: hypotension, tachycardia, nausea, vomiting, flushing, headache, feeling of warmth, tremor, metallic taste, abdominal pain, back pain, chest pain and others.
20 minutes
Vasopressors administered
Time Frame: 20 minutes
The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted.
20 minutes
Anti nausea therapy
Time Frame: 20 minutes
20 minutes
Additional uterotonic medication administered
Time Frame: 20 minutes
20 minutes
Additional uterine massage
Time Frame: 20 minutes
20 minutes

Collaborators and Investigators

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

Sponsor

Maisonneuve-Rosemont Hospital

Collaborators

Université de Montréal

Investigators

  • Principal Investigator: Christian Loubert, MD, FRCPC, Maisonneuve-Rosemont Hospital

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

March 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 17, 2012

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LoubertHMR2012/01

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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