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Propranolol Rescue of Prolonged Labor (PROPEL)

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ClinicalTrials.gov Identifier: NCT04299438
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Lisa Levine, University of Pennsylvania

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 326 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 : July 14, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Propranolol
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Drug: Propranolol Hydrochloride
2mg/mL vials
Other Name: 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




Primary Outcome Measures :
  1. Mode of Delivery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: from time of delivery through hospital discharge ]
    Amount of blood loss measured in mL

  3. Chorioamnionitis [ Time Frame: from start of labor through delivery ]
    Counts of cases of chorioamnionitis

  4. Maternal morbidity [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Moderate or severe 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299438


Contacts
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Contact: Director of Clinical Trial Oversight, WHCRC 203-662-3324 tracey.thomas@pennmedicine.upenn.edu
Contact: Lisa Levine, MD lisa.levine@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lisa Levine, MD       lisa.levine@pennmedicine.upenn.edu   
Principal Investigator: Lisa Levine, MD, MSCE         
Sub-Investigator: Jennifer McCoy, MD         
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jennifer McCoy, MD       jennifer.mccoy@pennmedicine.upenn.edu   
Principal Investigator: Lisa Levine, MD, MSCE         
Sub-Investigator: Jennifer McCoy, MD         
Sponsors and Collaborators
Lisa Levine
Investigators
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Principal Investigator: Lisa Levine, MD, MSCE University of Pennsylvania
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Responsible Party: Lisa Levine, Assistant Professor of Obstetrics and Gynecology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04299438    
Other Study ID Numbers: 834760
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Pennsylvania:
Propranolol
Cesarean
Additional relevant MeSH terms:
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Pregnancy, Prolonged
Pregnancy Complications
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents