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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

May 17, 2012
June 27, 2012
April 2012
July 2012   (final data collection date for primary outcome measure)
Utilization of a second uterotonic drug [ Time Frame: First 48 hours of the postpartum ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01630187 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section
Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Uterine Atony
  • Post-partum Hemorrhage
  • Drug: Carbetocin
    Administration of carbetocin 50 mcg , after clamping the umbilical cord
  • Drug: Carbetocin
    Administration of carbetocin 100 mcg , after clamping the umbilical cord
  • Active Comparator: Carbetocin 100 mcg
    Intervention: Drug: Carbetocin
  • Experimental: Carbetocin 50 mcg
    Intervention: Drug: Carbetocin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Lorrie Tremblay 418-255-9117 lorrie.tremblay.1@ulaval.ca
Canada
 
NCT01630187
CARB-011
No
Laval University
Laval University
Not Provided
Principal Investigator: Julie Bédard Laval University
Laval University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP