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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959436
• Other study ID #: 2017-836
• Status: Completed
• Start date: March 29, 2017
• Est. completion date: March 16, 2018

Study information

• Verified date: May 2019
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 612
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All Cesarean deliveries in the operating room.

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Carbetocin
Carbetocin as the primary uterotonic for all cesarean sections

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital	Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of additional uterotonics	The number of participants requiring additional uterotonics after using carbetocin as the initial uterotonic	24 hours