PROPEL: Propranolol Rescue of Prolonged Labor

Sponsor
Lisa Levine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04299438
Collaborator
(none)
164
2
2
24.6
82
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
  • 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 21, 2022