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Oxytocic Agent
Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section
Phase 4
Waitlist Available
Led By Julie Bédard
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
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.
Eligible Conditions
- Postpartum hemorrhage
- Bleeding after childbirth
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
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.
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Carbetocin 50 mcgExperimental Treatment1 Intervention
Group II: Carbetocin 100 mcgActive Control1 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?
Laval UniversityLead Sponsor
434 Previous Clinical Trials
178,469 Total Patients Enrolled
Julie BédardPrincipal InvestigatorLaval University