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

NCT01630187 — Phase 4, Completed, 72 participants, Laval University

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Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial

RegistryNCT01630187
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment72 (Actual)
SponsorLaval University (Other)
ConditionsUterine Atony, Post-partum Hemorrhage
InterventionsCarbetocin (Drug)
Datesstart 2012-04-01, primary completion 2012-07-01, completion 2012-07-01, first posted 2012-06-28, last updated 2013-05-29
Locations1 site in Canada

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Carbetocin 100 mcgActive comparatorDrug: Carbetocin
Carbetocin 50 mcgExperimentalDrug: Carbetocin
  • Carbetocin (Drug): Administration of carbetocin 50 mcg , after clamping the umbilical cord
  • Carbetocin (Drug): Administration of carbetocin 100 mcg , after clamping the umbilical cord

+Outcome measures

Primary outcomes

  • Utilization of a second uterotonic drug [First 48 hours of the postpartum]

Secondary outcomes

  • Incidence of side effects [During the fifteen minutes following the administration of carbetocin]
  • Incidence of major complications [First 48 hours of the postpartum]
  • Drop in hemoglobin measurement [on the second post-partum day]

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Hôpital Saint-François-d'Assise (CHUQ)Québec, QuebecCanada

+Investigators

  • Julie Bédard, Principal investigator, Laval University

My Notes