Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

Mount Sinai Health System

Status and phase: Completed; Phase 2

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Drug: Placebo; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT03348683

GCO 17-1441

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nulliparous women undergoing induction of labor
• >37 weeks' gestational age
• Non-anomalous, singleton cephalic presenting fetus.

Exclusion criteria

• Multiple gestations, known fetal anomalies
• Maternal cardiac or hypertensive disease
• Chronic beta blocker use
• Bronchial asthma
• Maternal or fetal indication for immediate delivery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

Propranolol

Experimental group

Description:

2mg of IV push

Treatment:

Drug: Propranolol

Placebo

Placebo Comparator group

Description:

an equivalent quantity in milliliters of normal saline

Treatment:

Drug: Placebo