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Propranolol Rescue of Prolonged Labor (PROPEL)

Primary Purpose

Pregnancy, Prolonged

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Propranolol Hydrochloride
Saline
Sponsored by
Lisa Levine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy, Prolonged focused on measuring Propranolol, Cesarean

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Hospital of the University of Pennsylvania
  • Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Propranolol

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mode of Delivery
Number of participants with a cesarean delivery

Secondary Outcome Measures

Length of Labor
Time in hours from start of labor or induction of labor to delivery
Postpartum Hemorrhage
Amount of blood loss measured in mL
Chorioamnionitis
Number of participants with chorioamnionitis
Maternal Morbidity
Number of participants with 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death
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

Full Information

First Posted
February 25, 2020
Last Updated
August 21, 2023
Sponsor
Lisa Levine
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1. Study Identification

Unique Protocol Identification Number
NCT04299438
Brief Title
Propranolol Rescue of Prolonged Labor
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Stopped at interim analysis
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisa Levine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Prolonged
Keywords
Propranolol, Cesarean

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Active Comparator
Arm Description
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later
Intervention Type
Drug
Intervention Name(s)
Propranolol Hydrochloride
Other Intervention Name(s)
Inderal
Intervention Description
2mg/mL vials
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
0.9% saline in vials matching the vials of the active drug
Primary Outcome Measure Information:
Title
Mode of Delivery
Description
Number of participants with a cesarean delivery
Time Frame
From enrollment into the trial until delivery.
Secondary Outcome Measure Information:
Title
Length of Labor
Description
Time in hours from start of labor or induction of labor to delivery
Time Frame
hours from start of labor or induction of labor to time of delivery
Title
Postpartum Hemorrhage
Description
Amount of blood loss measured in mL
Time Frame
from time of delivery through hospital discharge, usually 2-4 days
Title
Chorioamnionitis
Description
Number of participants with chorioamnionitis
Time Frame
from start of labor through delivery
Title
Maternal Morbidity
Description
Number of participants with 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death
Time Frame
from delivery through 4 weeks postpartum
Title
Neonatal Morbidity
Description
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
Time Frame
from delivery through hospital discharge, usually 2-4 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Levine, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Propranolol Rescue of Prolonged Labor

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