Propranolol Rescue of Prolonged Labor (PROPEL)

Lisa Levine

Status and phase: Terminated; Phase 3

Conditions: Pregnancy, Prolonged

Treatments: Other: Saline; Drug: Propranolol Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04299438

834760

Details and patient eligibility

About

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

Full 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.

Enrollment: 164 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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164 participants in 2 patient groups, including a placebo group

Propranolol

Active Comparator group

Description:

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

Treatment:

Drug: Propranolol Hydrochloride

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Saline