Cardiovascular Effects of Carbetocin Given During Elective Cesarean

November 15, 2016 updated by: University of British Columbia

Cardiovascular Effects of Carbetocin During Elective Caesarean Delivery: A Randomized Controlled Trial Comparing Infusion Versus Bolus Administration Using Nexfin™

The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing elective cesarean under spinal are included in the study. These patients are treated with carbetocin to reduce blood loss from the lining of the womb after delivery of the baby. The study is a randomised double blind controlled trial with 2 groups. One group will receive carbetocin quickly, the second group will receive carbetocin slowly. The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.

Study Type

Interventional

Enrollment (Actual)

57

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
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women's Hospital

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • elective cesarean delivery under spinal,
  • low risk for post partum hemorrhage,
  • able to understand english

Exclusion Criteria:

  • cesarean under general anesthesia,
  • bleeding condition,
  • placenta previa,
  • unable to understand english

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infusion
carbetocin is given slowly
Drug: carbetocin
drug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery.
Other Names:
  • Duratocin
Active Comparator: Bolus
carbetocin is given quickly
Drug: carbetocin
drug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery.
Other Names:
  • Duratocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percent change in cardiac output parameters as measured by non-invasive cardiac output monitor
Time Frame: 10 minutes
the parameters will be presented as percentage change from the baseline, which is determined prior to the start of the study period
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of side effects occurring within timeframe below
Time Frame: 30 minutes
headache, nausea, vomiting, facial flushing
30 minutes

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

Edwards Lifesciences

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, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H15-03007

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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