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

NCT03959436 | Completed

• 1 other identifier: 2017-836
• Study Type: observational
• Target: 612
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Use of additional uterotonics

  The number of participants requiring additional uterotonics after using carbetocin as the initial uterotonic

  24 hours

Interventions

Carbetocin DRUG

Carbetocin as the primary uterotonic for all cesarean sections

Also known as: Duratocin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant patients requiring cesarean section.

You may qualify if:

• All Cesarean deliveries in the operating room.

You may not qualify if:

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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Maisonneuve-Rosemont hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (6)

• 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.

  PMID: 9659650 BACKGROUND

• 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.

  PMID: 10076146 BACKGROUND

• 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.

  PMID: 19229549 BACKGROUND

• 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.

  PMID: 20482535 BACKGROUND

• 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.

  PMID: 19941729 BACKGROUND

• 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.

  PMID: 22513931 BACKGROUND

MeSH Terms

Interventions

carbetocin

Study Officials

• Valerie Zaphiratos, MSc, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

• Philippe Richebé, MD, PhD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Unit Chief of Obstetric Anesthesia

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: March 29, 2017
• Primary Completion: March 16, 2018
• Study Completion: March 16, 2018
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Our plan is to publish in the coming year.

Locations

CA (1)