PROPEL: Propranolol Rescue of Prolonged Labor

• Sponsor: Lisa Levine (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04299438
• Collaborator: (none)
• Enrollment: 164
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 24.6
• Patients Per Site: 82
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, Prolonged	Drug: Propranolol Hydrochloride; Other: Saline	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jul 14, 2020
• Actual Primary Completion Date: Jun 15, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Propranolol IV Propranolol - 2mg; one possible repeat dose ≥2 hours later	Drug: Propranolol Hydrochloride; 2mg/mL vials; Other Names: Inderal
Placebo Comparator: Placebo Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later	Other: Saline; 0.9% saline in vials matching the vials of the active drug

Outcome Measures

Primary Outcome Measures

1. Mode of Delivery [From enrollment into the trial until delivery.]

   Percentage of women that have a cesarean delivery compared to a vaginal delivery.

Secondary Outcome Measures

1. Length of Labor [hours from start of labor or induction of labor to time of delivery]

   Time in hours from start of labor or induction of labor to delivery

2. Postpartum hemorrhage [from time of delivery through hospital discharge]

   Amount of blood loss measured in mL

3. Chorioamnionitis [from start of labor through delivery]

   Counts of cases of chorioamnionitis

4. Maternal morbidity [from delivery through 4 weeks postpartum]

   Counts of cases of 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death

5. Neonatal morbidity [from delivery through hospital discharge]

   Counts of cases of 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Lisa Levine

Investigators

• Principal Investigator: Lisa Levine, MD, MSCE, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lisa Levine, Assistant Professor of Obstetrics and Gynecology, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04299438
• Other Study ID Numbers: 834760
• First Posted: Mar 6, 2020
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Lisa Levine, Assistant Professor of Obstetrics and Gynecology, University of Pennsylvania: Propranolol; Cesarean
• Additional relevant MeSH terms: Pregnancy, Prolonged; Propranolol

Study Results

No Results Posted as of Jun 21, 2022