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Oxytocic Agent
Carbetocin for Postpartum Hemorrhage
Phase 4
Waitlist Available
Led By Christian Loubert, MD, FRCPC
Research Sponsored by Maisonneuve-Rosemont Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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.
Eligible Conditions
- Postpartum Hemorrhage
- Uterine Atony
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose of carbetocin which will prevent uterine atony in 90% of subjects
Secondary study objectives
Incidence of side effects
Vasopressors administered
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CarbetocinExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbetocin
FDA approved
Find a Location
Who is running the clinical trial?
Université de MontréalOTHER
221 Previous Clinical Trials
104,240 Total Patients Enrolled
Maisonneuve-Rosemont HospitalLead Sponsor
101 Previous Clinical Trials
38,287 Total Patients Enrolled
Christian Loubert, MD, FRCPCPrincipal InvestigatorMaisonneuve-Rosemont Hospital
2 Previous Clinical Trials
50 Total Patients Enrolled
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