Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

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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

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

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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