Propranolol Rescue of Prolonged Labor

Study Overview
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Brief Summary
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A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women given IV propranolol versus placebo for treatment of prolonged labor.

Detailed Description
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A double-blind placebo controlled randomized trial comparing cesarean delivery rates in 326 women given IV propranolol (2 mg with one possible repeat dose greater than 2 hours later) versus IV placebo for treatment of prolonged labor.

Official Title
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Propranolol Rescue of Prolonged Labor (PROPEL): A Randomized, Double-blind, Placebo-controlled Multicenter Investigation of Propranolol's Effect on Cesarean Delivery Rate Among Women With Prolonged Labor

Conditions
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Pregnancy, Prolonged

Intervention / Treatment
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* Drug: Propranolol Hydrochloride
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking >= 36 weeks gestation Singleton pregnancy Vertex presentation No contraindication to a vaginal delivery Meets at least one study criteria for prolonged labor: cervical dilation <6 cm after ≥8 hours with ruptured membranes and receiving oxytocin OR cervical dilation >=6 cm and <1 cm dilation change over ≥2 hours with ruptured membranes and receiving oxytocin Exclusion Criteria: Severe preeclampsia: as patients will be receiving magnesium and possibly labetalol for hypertension control Receiving other beta blocker Maternal heart rate < 70 beats per minute, systolic blood pressure <90 mmHg, or diastolic blood pressure <50 mmHg on two sets of vital signs in the 1 hour prior to study drug administration: given that bradycardia and hypotension are possible side effects of propranolol History of any form of asthma: as this is a contraindication to beta blocker use Diabetes requiring insulin in labor: given the potential risk of neonatal hypoglycemia in the neonate Any cardiac condition for which β blockade is contraindicated (cardiogenic shock, sinus bradycardia, and greater than first degree heart block) Known hypersensitivity to propranolol Intrauterine fetal demise since different labor protocols are used in these women Major fetal congenital anomaly since rate of cesarean may be inherently different in these women, unrelated to labor

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propranolol<br>IV Propranolol - 2mg; one possible repeat dose ≥2 hours later | Drug: Propranolol Hydrochloride<br>* 2mg/mL vials<br>* Other names: Inderal;|
| Placebo Comparator: Placebo<br>Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later | Other: Saline<br>* 0.9% saline in vials matching the vials of the active drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of Delivery | Number of participants with a cesarean delivery | From enrollment into the trial until delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Labor | Time in hours from start of labor or induction of labor to delivery | hours from start of labor or induction of labor to time of delivery | 
| Postpartum Hemorrhage | Amount of blood loss measured in mL | from time of delivery through hospital discharge, usually 2-4 days | 
| Chorioamnionitis | Number of participants with chorioamnionitis | from start of labor through delivery | 
| Maternal Morbidity | Number of participants with 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death | from delivery through 4 weeks postpartum | 
| Neonatal Morbidity | Number of participants with 1 or more of the following: Intensive care nursery admission >48, blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, neonatal head cooling, severe respiratory distress syndrome, necrotizing enterocolitis, sepsis, death | from delivery through hospital discharge, usually 2-4 days | 

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