Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

Phase 2

Completed

Conditions: Induction of Labor Affected Fetus / Newborn

Interventions: Drug: Placebo
Drug: Propranolol

Registration Number: NCT03348683

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 240

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	an equivalent quantity in milliliters of normal saline
Propranolol	Propranolol	2mg of IV push

Primary Outcome Measures

Name	Time	Method
Time From Beginning of Induction to Delivery	average of 24 hours	The time of induction (based on time of foley balloon placement for cervical ripening or misoprostol administration) to the time of delivery of the infant.

Secondary Outcome Measures

Name	Time	Method
Number of Fetus With Fetal Bradycardia	30 minutes from drug administration	Count of fetus with fetal bradycardia (\<110bpm for \>10 minutes within 30 minutes of study drug administration)
Number of Participants With Various Mode of Delivery	average of 24 hours	Number of various mode of delivery - count of Vaginal delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery, cesarean section
Number of Participants With Postpartum Hemorrhage	30 minutes from drug administration	Greater than 500cc of blood expelled during a vaginal delivery or greater than 1000cc of blood expelled during a cesarean section
Number of Participants With Maternal Morbidity Composite Score = 1	average of 24 hours	Composite maternal morbidity score consists of a count of postpartum hemorrhage, transfusion, hysterectomy, placental abruption, chorioamnionitis, shoulder dystocia, episiotomy, higher order laceration, and ICU admission. The composite score was computed as a score of 1 for any indication of maternal morbidity, that is the participant experienced at least one maternal morbidity, and the components are given equal weights. Participants who had no evidence of the predefined maternal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1.
Number of Neonates With Neonatal Outcome Composite Score = 1	Day 1	Composite neonatal outcome score was for any of the following morbidity: Neonatal Intensive Care Unit (NICU) admission, respiratory support (CPAP, nasal cannula, intubation), culture proven sepsis, radiographically proven intracranial hemorrhage, necrotizing enterocolitis, hypoglycemia (for those infants who had sugar checked), and neonatal death. The composite score was computed as a score of 1 for any indication of neonatal morbidity - neonates who experienced at least one morbidity and the components are given equal weights. Patients who had no evidence of the predefined neonatal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1.
Number of Neonates With Hypoglycemia	Day 1	Neonatal outcome - Number of neonates with hypoglycemia (blood glucose \<50). This population includes only the neonates who had heelsticks to check their blood glucose, which is not a universal practice and was not required by the protocol or IRB. The neonates included were those who met the nursery's risk-based protocol to check blood glucose after birth (ex: infants of diabetic mothers, fetal growth restriction, macrosomia, or symptoms suggestive of hypoglycemia)
Duration of Latent	average of 24 hours	Time of latent labor defined as \<6cm of cervical dilation.
Number of Fetus With Heart Rate Decelerations	30 minutes from drug administration	Count of fetus with fetal heart rate decelerations within 30 minutes of study drug administration