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Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section

This study is currently recruiting participants.
Verified March 2012 by Laval University
Sponsor:
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT01630187
First received: May 17, 2012
Last updated: June 27, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.


Condition Intervention Phase
Uterine Atony
Post-partum Hemorrhage
 Drug: Carbetocin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Utilization of a second uterotonic drug [ Time Frame: First 48 hours of the postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of side effects [ Time Frame: During the fifteen minutes following the administration of carbetocin ] [ Designated as safety issue: No ]
  • Incidence of major complications [ Time Frame: First 48 hours of the postpartum ] [ Designated as safety issue: No ]
  • Drop in hemoglobin measurement [ Time Frame: on the second post-partum day ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: April 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Carbetocin 100 mcg Drug: Carbetocin
Administration of carbetocin 100 mcg , after clamping the umbilical cord
Experimental: Carbetocin 50 mcg Drug: Carbetocin
Administration of carbetocin 50 mcg , after clamping the umbilical cord

Detailed Description:

Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.

Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old
  • ≥ 37-week pregnancy
  • singleton pregnancy
  • elective cesarean section with a low transverse incision
  • ASA I or II

Exclusion Criteria:

  • Personal history of uterine atony or postpartum hemorrhage
  • Abnormal placental implantation (known or suspected)
  • > 3 cesarean sections in the past
  • Personal history of a classic uterine incision
  • Estimated fetal weight > 4500g
  • Hemoglobin < 100 g/L
  • Regular use of tocolytic drugs
  • Cesarean section under general anesthesia
  • Known allergy to carbetocin
  • Refusal
  • Inability to obtain informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630187

Contacts
Contact: Lorrie Tremblay 418-255-9117 lorrie.tremblay.1@ulaval.ca

Locations
Canada
Hôpital Saint-François-d'Assise (CHUQ) Recruiting
Quebec, Canada, G1L 3L5
Contact: Lorrie Tremblay     418-255-9117     lorrie.tremblay.1@ulaval.ca    
Principal Investigator: Julie Bédard            
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Julie Bédard Laval University
  More Information

No publications provided

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01630187     History of Changes
Other Study ID Numbers: CARB-011
Study First Received: May 17, 2012
Last Updated: June 27, 2012
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Carbetocin
Uterotonic drug
elective cesarean section

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Uterine Inertia
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
 Dystocia
Carbetocin
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013