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

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ClinicalTrials.gov Identifier: NCT03959436
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Valerie Zaphiratos, Maisonneuve-Rosemont Hospital

Brief 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.

Condition or disease Intervention/treatment
Carbetocin Cesarean Section Complications Uterotonics Uterine Atony With Hemorrhage Drug: Carbetocin

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Study Type : Observational [Patient Registry]
Actual Enrollment : 612 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Prospective Observational Database Evaluating Outcomes of Using Carbetocin (Duratocin®) as the Primary Uterotonic Following Cesarean Delivery at Maisonneuve-Rosemont Hospital
Actual Study Start Date : March 29, 2017
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : March 16, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Carbetocin
    Carbetocin as the primary uterotonic for all cesarean sections
    Other Name: Duratocin


Primary Outcome Measures :
  1. Use of additional uterotonics [ Time Frame: 24 hours ]
    The number of participants requiring additional uterotonics after using carbetocin as the initial uterotonic



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant patients requiring cesarean section.
Criteria

Inclusion Criteria:

  • All Cesarean deliveries in the operating room.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959436


Locations
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Canada, Quebec
Maisonneuve-Rosemont hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Ferring Pharmaceuticals
Investigators
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Principal Investigator: Valerie Zaphiratos, MSc, MD Maisonneuve-Rosemont Hospital
Principal Investigator: Philippe Richebé, MD, PhD Maisonneuve-Rosemont Hospital

Publications:

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Responsible Party: Valerie Zaphiratos, Unit Chief of Obstetric Anesthesia, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT03959436     History of Changes
Other Study ID Numbers: 2017-836
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Our plan is to publish in the coming year.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Uterine Inertia
Pathologic Processes
Dystocia
Obstetric Labor Complications
Pregnancy Complications
Carbetocin
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs