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出境医 / 临床实验 / Database Evaluating Outcomes of Using Carbetocin as the Primary Uterotonic Following Cesarean Delivery

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
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


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 20, 2019
First Posted Date May 22, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date March 29, 2017
Actual Primary Completion Date March 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2019) 		Use of additional uterotonics [ Time Frame: 24 hours ]
The number of participants requiring additional uterotonics after using carbetocin as the initial uterotonic
Original Primary Outcome Measures
 (submitted: May 21, 2019) 		Use of additional uterotonics [ Time Frame: 24 hours ]
The use of additional uterotonics after using carbetocin as the initial uterotonic
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Database Evaluating Outcomes of Using Carbetocin as the Primary Uterotonic Following Cesarean Delivery
Official Title Prospective Observational Database Evaluating Outcomes of Using Carbetocin (Duratocin®) as the Primary Uterotonic Following Cesarean Delivery at 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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Days
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Pregnant patients requiring cesarean section.
Condition
  • Carbetocin
  • Cesarean Section Complications
  • Uterotonics
  • Uterine Atony With Hemorrhage
Intervention Drug: Carbetocin
Carbetocin as the primary uterotonic for all cesarean sections
Other Name: Duratocin
Study Groups/Cohorts Not Provided
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 21, 2019) 		612
Original Actual Enrollment Same as current
Actual Study Completion Date March 16, 2018
Actual Primary Completion Date March 16, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959436
Other Study ID Numbers 2017-836
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Our plan is to publish in the coming year.
Responsible Party Valerie Zaphiratos, Maisonneuve-Rosemont Hospital
Study Sponsor Maisonneuve-Rosemont Hospital
Collaborators Ferring Pharmaceuticals
Investigators
Principal Investigator: Valerie Zaphiratos, MSc, MD Maisonneuve-Rosemont Hospital
Principal Investigator: Philippe Richebé, MD, PhD Maisonneuve-Rosemont Hospital
PRS Account Maisonneuve-Rosemont Hospital
Verification Date May 2019

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