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ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery

NCT01579201 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-02-15

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Université de Montréal

    collaborator OTHER

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Christian Loubert, MD, FRCPC · Maisonneuve-Rosemont Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01579201 on ClinicalTrials.gov