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

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ClinicalTrials.gov Identifier: NCT01630187
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Laval University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Uterine Atony Post-partum Hemorrhage Drug: Carbetocin Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Utilization of a second uterotonic drug [ Time Frame: First 48 hours of the postpartum ]

Secondary Outcome Measures :
  1. Incidence of side effects [ Time Frame: During the fifteen minutes following the administration of carbetocin ]
  2. Incidence of major complications [ Time Frame: First 48 hours of the postpartum ]
  3. Drop in hemoglobin measurement [ Time Frame: on the second post-partum day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630187


Locations
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Canada
Hôpital Saint-François-d'Assise (CHUQ)
Quebec, Canada, G1L 3L5
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Julie Bédard Laval University
More Information
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Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01630187    
Other Study ID Numbers: CARB-011
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013
Keywords provided by Laval University:
Carbetocin
Uterotonic drug
elective cesarean section
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Uterine Inertia
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
 Uterine Hemorrhage
Dystocia
Carbetocin
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs