Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

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

Detailed Description
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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.

Official Title
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Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients: a Double-blind Randomized Controlled Trial

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Drug: Propranolol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propranolol<br>2mg of IV push | Drug: Propranolol<br>* After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.<br>|
| Placebo Comparator: Placebo<br>an equivalent quantity in milliliters of normal saline | Drug: Placebo<br>* After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | average of 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | average of 24 hours | 
| Duration of Latent | Time of latent labor defined as <6cm of cervical dilation. | 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. | 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 | 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 | 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) | 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. | 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) | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induction, Labor, Propranolol