Status:
TERMINATED
Propranolol Rescue of Prolonged Labor
Lead Sponsor:
Lisa Levine
Conditions:
Pregnancy, Prolonged
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2022
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04299438
Start Date
July 14 2020
End Date
July 15 2022
Last Update
August 23 2023
Active Locations (2)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107