Database Evaluating Outcomes of Using Carbetocin as the Primary Uterotonic Following Cesarean Delivery

May 27, 2019 updated by: Valerie Zaphiratos, Maisonneuve-Rosemont Hospital

Prospective Observational Database Evaluating Outcomes of Using Carbetocin (Duratocin®) as the Primary Uterotonic Following Cesarean Delivery at Maisonneuve-Rosemont Hospital

Carbetocin (Duratocin®) is a long-acting form of oxytocin, with a half-life almost 10 times longer. Studies have demonstrated that carbetocin diminishes the need for secondary uterotonic agents compared to oxytocin for cesarean delivery (CD). Despite certain Canadian guidelines recommending its use for elective CD, several Canadian centers and other countries have not adopted carbetocin. The purpose of this study is to prospectively gather electronic data on all CDs over a one year period, elective and emergent, in a single institution, and to evaluate the efficacy and other clinical outcomes when carbetocin is used as a first line uterotonic for all CDs. A database using Microsoft Dynamics CRM is available on smart phones and tablets. Data regarding additional uterotonic use and impact of carbetocin use during CD on intra and postoperative outcomes are gathered and analyzed. The primary outcome is the use of additional uterotonics in this population compared to that described in the literature for oxytocin as the primary uterotonic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

612

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
        • Maisonneuve-Rosemont 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant patients requiring cesarean section.

Description

Inclusion Criteria:

  • All Cesarean deliveries in the operating room.

Exclusion Criteria:

  • Vaginal deliveries and double set-up vaginal deliveries conducted in the operating room.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of additional uterotonics
Time Frame: 24 hours
The number of participants requiring additional uterotonics after using carbetocin as the initial uterotonic
24 hours

Collaborators and Investigators

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

Sponsor

Maisonneuve-Rosemont Hospital

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Valerie Zaphiratos, MSc, MD, Maisonneuve-Rosemont Hospital
  • Principal Investigator: Philippe Richebé, MD, PhD, Maisonneuve-Rosemont Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

March 29, 2017

Primary Completion (ACTUAL)

March 16, 2018

Study Completion (ACTUAL)

March 16, 2018

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (ACTUAL)

May 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-836

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To publish this data in a journal. Data includes primary outcomes and secondary outcomes related to uterotonic use and uterine atony and hemorrhage.

IPD Sharing Time Frame

Our plan is to publish in the coming year.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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