Propranolol Rescue of Prolonged Labor

NCT04299438 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 834760
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pregnancy, Prolonged

Keywords

Propranolol; Cesarean

Outcome Measures

Primary Outcomes (1)

• Mode of Delivery

  Number of participants with a cesarean delivery

  From enrollment into the trial until delivery.

Secondary Outcomes (5)

• Length of Labor

  hours from start of labor or induction of labor to time of delivery

• Postpartum Hemorrhage

  from time of delivery through hospital discharge, usually 2-4 days

• Chorioamnionitis

  from start of labor through delivery

• Maternal Morbidity

  from delivery through 4 weeks postpartum

• Neonatal Morbidity

  from delivery through hospital discharge, usually 2-4 days

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

IV Propranolol - 2mg; one possible repeat dose ≥2 hours later

Drug: Propranolol Hydrochloride

Placebo

PLACEBO COMPARATOR

Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later

Other: Saline

Interventions

Propranolol Hydrochloride DRUG

2mg/mL vials

Also known as: Inderal

Propranolol

Saline OTHER

0.9% saline in vials matching the vials of the active drug

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lisa Levine: lead

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• McCoy JA, Walheim L, McCabe MG, Levine LD. Efficacy of Propranolol to Reduce Cesarean Delivery in Prolonged Labor: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):71-79. doi: 10.1097/AOG.0000000000005232. Epub 2023 Jun 7.

  PMID: 37290102 DERIVED

MeSH Terms

Conditions

Pregnancy, Prolonged

Interventions

Propranolol; Sodium Chloride

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Jennifer McCoy
• Organization: University of Pennsylvania

jennifer.mccoy@pennmedicine.upenn.edu

215 662 4000

Study Officials

• Lisa Levine, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 6, 2020
• Study Start: July 14, 2020
• Primary Completion: June 15, 2022
• Study Completion: July 15, 2022
• Last Updated: August 23, 2023
• Results First Posted: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)