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

NCT ID: NCT03959436

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

612 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-29

Study Completion Date

2018-03-16

Brief Summary

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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.

Detailed Description

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Conditions

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Carbetocin Cesarean Section Complications Uterotonics Uterine Atony With Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Carbetocin

Carbetocin as the primary uterotonic for all cesarean sections

Intervention Type DRUG

Other Intervention Names

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Duratocin

Eligibility Criteria

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Inclusion Criteria

* All Cesarean deliveries in the operating room.

Exclusion Criteria

* Vaginal deliveries and double set-up vaginal deliveries conducted in the operating room.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Valerie Zaphiratos

Unit Chief of Obstetric Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valerie Zaphiratos, MSc, MD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Philippe Richebé, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

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Maisonneuve-Rosemont hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Dansereau J, Joshi AK, Helewa ME, Doran TA, Lange IR, Luther ER, Farine D, Schulz ML, Horbay GL, Griffin P, Wassenaar W. Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section. Am J Obstet Gynecol. 1999 Mar;180(3 Pt 1):670-6. doi: 10.1016/s0002-9378(99)70271-1.

Reference Type BACKGROUND
PMID: 10076146 (View on PubMed)

Borruto F, Treisser A, Comparetto C. Utilization of carbetocin for prevention of postpartum hemorrhage after cesarean section: a randomized clinical trial. Arch Gynecol Obstet. 2009 Nov;280(5):707-12. doi: 10.1007/s00404-009-0973-8. Epub 2009 Feb 20.

Reference Type BACKGROUND
PMID: 19229549 (View on PubMed)

Boucher M, Horbay GL, Griffin P, Deschamps Y, Desjardins C, Schulz M, Wassenaar W. Double-blind, randomized comparison of the effect of carbetocin and oxytocin on intraoperative blood loss and uterine tone of patients undergoing cesarean section. J Perinatol. 1998 May-Jun;18(3):202-7.

Reference Type BACKGROUND
PMID: 9659650 (View on PubMed)

Attilakos G, Psaroudakis D, Ash J, Buchanan R, Winter C, Donald F, Hunt LP, Draycott T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage following caesarean section: the results of a double-blind randomised trial. BJOG. 2010 Jul;117(8):929-36. doi: 10.1111/j.1471-0528.2010.02585.x. Epub 2010 May 19.

Reference Type BACKGROUND
PMID: 20482535 (View on PubMed)

Leduc D, Senikas V, Lalonde AB; CLINICAL PRACTICE OBSTETRICS COMMITTEE. Active management of the third stage of labour: prevention and treatment of postpartum hemorrhage. J Obstet Gynaecol Can. 2009 Oct;31(10):980-993. doi: 10.1016/S1701-2163(16)34329-8.

Reference Type BACKGROUND
PMID: 19941729 (View on PubMed)

Su LL, Chong YS, Samuel M. Carbetocin for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD005457. doi: 10.1002/14651858.CD005457.pub4.

Reference Type BACKGROUND
PMID: 22513931 (View on PubMed)

Other Identifiers

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2017-836

Identifier Type: -

Identifier Source: org_study_id

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