A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.
After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Time From Beginning of Induction to Delivery
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.
Time frame: average of 24 hours
Number of Participants With Various Mode of Delivery
Number of various mode of delivery - count of Vaginal delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery, cesarean section
Time frame: average of 24 hours
Duration of Latent
Time of latent labor defined as \<6cm of cervical dilation.
Time frame: average of 24 hours
Number of Participants With Maternal Morbidity Composite Score = 1
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.
Time frame: average of 24 hours
Number of Participants With Postpartum Hemorrhage
Greater than 500cc of blood expelled during a vaginal delivery or greater than 1000cc of blood expelled during a cesarean section
Time frame: 30 minutes from drug administration
Number of Fetus With Heart Rate Decelerations
Count of fetus with fetal heart rate decelerations within 30 minutes of study drug administration
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Time frame: 30 minutes from drug administration
Number of Fetus With Fetal Bradycardia
Count of fetus with fetal bradycardia (\<110bpm for \>10 minutes within 30 minutes of study drug administration)
Time frame: 30 minutes from drug administration
Number of Neonates With Neonatal Outcome Composite Score = 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.
Time frame: Day 1
Number of Neonates With Hypoglycemia
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)
Time frame: Day 1