Clinical trial NCT03348683: Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
Official title: Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Induction of Labor Affected Fetus / Newborn
Keywords: Induction
Labor
Propranolol
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time From Beginning of Induction to Delivery
timeFrame: average of 24 hours
Secondary outcomes:
measure: Number of Participants With Various Mode of Delivery
timeFrame: average of 24 hours
measure: Duration of Latent
timeFrame: average of 24 hours
measure: Number of Participants With Maternal Morbidity Composite Score = 1
timeFrame: average of 24 hours
measure: Number of Participants With Postpartum Hemorrhage
timeFrame: 30 minutes from drug administration
measure: Number of Fetus With Heart Rate Decelerations
timeFrame: 30 minutes from drug administration
measure: Number of Fetus With Fetal Bradycardia
timeFrame: 30 minutes from drug administration
measure: Number of Neonates With Neonatal Outcome Composite Score = 1
timeFrame: Day 1
measure: Number of Neonates With Hypoglycemia
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Joanne Stone, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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