Propranolol Rescue of Prolonged Labor (PROPEL)

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

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

Study Overview

• Status: Terminated
• Conditions: Pregnancy, Prolonged
• Intervention / Treatment: Drug: Propranolol Hydrochloride; Other: Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

1. cervical dilation <6 cm after ≥8 hours with ruptured membranes and receiving oxytocin OR
2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lisa Levine
• Investigators: Principal Investigator: Lisa Levine, MD, MSCE, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Propranolol; Cesarean
• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy, Prolonged; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: 834760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes