Propranolol Rescue of Prolonged Labor

Pregnancy, Prolonged Clinical Trial

— PROPEL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04299438
• Other study ID #: 834760
• Status: Terminated
• Phase: Phase 3
• Start date: July 14, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 164
• Est. completion date: July 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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 ß 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

Related Conditions & MeSH terms

• Pregnancy, Prolonged

Intervention

Drug:
• Propranolol Hydrochloride
2mg/mL vials

Other:
• Saline
0.9% saline in vials matching the vials of the active drug

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lisa Levine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mode of Delivery	Number of participants with a cesarean delivery	From enrollment into the trial until delivery.
Secondary	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
Secondary	Postpartum Hemorrhage	Amount of blood loss measured in mL	from time of delivery through hospital discharge, usually 2-4 days
Secondary	Chorioamnionitis	Number of participants with chorioamnionitis	from start of labor through delivery
Secondary	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
Secondary	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