Propranolol Rescue of Prolonged Labor

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lisa Levine
• Treatments: Propranolol

Criteria

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

Moderate or severe 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