Clinical trial NCT04299438: Propranolol Rescue of Prolonged Labor
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pregnancy, Prolonged
Keywords: Propranolol
Cesarean
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 164
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

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

Primary outcomes:
measure: Mode of Delivery
timeFrame: From enrollment into the trial until delivery.
Secondary outcomes:
measure: Length of Labor
timeFrame: hours from start of labor or induction of labor to time of delivery
measure: Postpartum Hemorrhage
timeFrame: from time of delivery through hospital discharge, usually 2-4 days
measure: Chorioamnionitis
timeFrame: from start of labor through delivery
measure: Maternal Morbidity
timeFrame: from delivery through 4 weeks postpartum
measure: Neonatal Morbidity
timeFrame: from delivery through hospital discharge, usually 2-4 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Lisa Levine, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: