NCT04299438

Propranolol Rescue of Prolonged Labor

Propranolol Rescue of Prolonged Labor (PROPEL): A Randomized, Double-blind, Placebo-controlled Multicenter Investigation of Propranolol's Effect on Cesarean Delivery Rate Among Women With Prolonged Labor

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Lisa Levine · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

A double-blind placebo controlled randomized trial comparing cesarean delivery rates in 326 women given IV propranolol (2 mg with one possible repeat dose greater than 2 hours later) versus IV placebo for treatment of prolonged labor.

Conditions

• Pregnancy, Prolonged

Interventions

Type	Name	Description
DRUG	Propranolol Hydrochloride	2mg/mL vials
OTHER	Saline	0.9% saline in vials matching the vials of the active drug

Timeline

• Start date: 2020-07-14
• Primary completion: 2022-06-15
• Completion: 2022-07-15
• First posted: 2020-03-06
• Last updated: 2023-08-23
• Results posted: 2023-08-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study