NCT03348683

Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients: a Double-blind Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.

Detailed description

Induction of labor is a common obstetric procedure, which is performed to provoke the onset of labor and lead to delivery of the fetus. While some early studies suggested a possible increased rate of cesarean with induction of labor, more recent meta-analyses have shown that induction does not influence this rate. There is data from small randomized studies that demonstrates the effectiveness of propranolol, a non-selective beta-blocker, for induction of labor. This literature suggests a decrease in the amount of time to delivery and a possible reduction in cesarean section rates when propranolol is used in conjunction with oxytocin for induction of labor compared to oxytocin alone.

Conditions

• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
DRUG	Propranolol	After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.
DRUG	Placebo	After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline

Timeline

• Start date: 2017-12-11
• Primary completion: 2018-12-11
• Completion: 2018-12-11
• First posted: 2017-11-21
• Last updated: 2020-01-07
• Results posted: 2019-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study