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

NCT03959436 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 612

Last updated 2019-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Carbetocin
  • Cesarean Section Complications
  • Uterotonics
  • Uterine Atony With Hemorrhage

Interventions

DRUG

Carbetocin

Carbetocin as the primary uterotonic for all cesarean sections

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Valerie Zaphiratos, MSc, MD · Maisonneuve-Rosemont Hospital

  • Philippe Richebé, MD, PhD · Maisonneuve-Rosemont Hospital

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2018-03-16
Completion
2018-03-16

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03959436 on ClinicalTrials.gov