Current partner codePEPTIDESDE
NCT03959436·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

612

Locations

1

Results

Not posted

Publications

6

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Carbetocin

Carbetocin as the primary uterotonic for all cesarean sections

Timeline

From registration to results.

  1. First posted

    May 22, 2019

  2. Study start

    Mar 29, 2017

  3. Primary completion

    Mar 16, 2018

  4. Study completion

    Mar 16, 2018

  5. Results posted

    Not reported

  6. Registry updated

    May 29, 2019

Outcomes

What the study measures.

Primary outcomes

Use of additional uterotonics

Time frame · 24 hours

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * All Cesarean deliveries in the operating room. Exclusion Criteria: * Vaginal deliveries and double set-up vaginal deliveries conducted in the operating room.

Study locations

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

Maisonneuve-Rosemont hospital

Montreal, Quebec, Canada

Publications

Results and literature.

PMID 9659650Boucher 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 10076146Dansereau 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 19229549Borruto 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 20482535Attilakos 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 19941729Leduc 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 22513931Su 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.

Primary links

Continue at the source.

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.