Recruiting

Carbetocin

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT01579201

Conditions

Postpartum Hemorrhage

Uterine Atony

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Carbetocin

Study Details

Brief summary:

The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.

Conditions

Postpartum Hemorrhage

Uterine Atony

Study ID

NCT01579201

Start date

Mar, 2012

Status verified date

Feb, 2013

Completion date

Mar, 2013

Anticipated

Primary completion date

Mar, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Healthy pregnant women (ASA I or II)
  • Elective cesarean delivery
  • Spinal anesthesia
  • Term gestation (37 weeks and above)

Exclusion Criteria:

  • Multiple gestation
  • Known coagulopathy
  • Active labour
  • Uterine fibroids
  • Body mass index > 45
  • Emergency cesarean section
  • General anesthesia
  • Any contraindication to neuraxial anesthesia
  • Cardiopathies
  • Known allergies to carbetocin
  • Patient refusal
  • Placenta previa/Placenta accreta
  • Hypertensive disease/Preeclampsia/Eclampsia
  • Polyhydramnios
  • Previous history of uterine atony or postpartum hemorrhage
  • Renal or liver disease

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Carbetocin

Interventions

Carbetocin

First patient: 70 mcg. Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg. An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change.

Primary outcome measure

  • Dose of carbetocin which will prevent uterine atony in 90% of subjects [ Time Frame: 5 minutes ]

Central Contacts and Locations

Central contacts

Christian Loubert, MD, FRCPC

514.252.3426loubertch@yahoo.fr

Louis-Philippe Fortier, MD, FRCPC

514.252.3426lpfortier@mac.com

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Christian Loubert, MD, FRCPC

514.252.3426loubertch@yahoo.fr

Louis-Philippe Fortier, MD, FRCPC

514.252.3426lpfortier@mac.com

Principal Investigator:

Christian Loubert, MD, FRCPC

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Feb 15, 2013

Last verified

Feb, 2013

Keywords

  • Postpartum Hemorrhage
  • Uterine Atony
  • Obstetric Anesthesia
  • Cesarean Section
  • Carbetocin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2013-02-15.