Propranolol Rescue of Prolonged Labor

(PROPEL Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Lisa Levine, MD, MSCE

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Lisa Levine

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women given IV propranolol versus placebo for treatment of prolonged labor.

Eligibility Criteria

Inclusion Criteria

English-speaking

>= 36 weeks gestation

Singleton pregnancy

Participant Groups

Group I: Propranolol Active Control 1 Intervention

IV Propranolol - 2mg; one possible repeat dose ≥2 hours later

Group II: Placebo Placebo Group 1 Intervention

Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later

Propranolol Hydrochloride is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Inderal for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Performance anxiety

🇪🇺 Approved in European Union as Inderal for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Performance anxiety

🇨🇦 Approved in Canada as Inderal for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Performance anxiety

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Hospital of the University of Pennsylvania Philadelphia, PA

Pennsylvania Hospital Philadelphia, PA

Who Is Running the Clinical Trial?

Lisa Levine Lead Sponsor

References