Propranolol Rescue of Prolonged Labor
- Conditions
- Pregnancy, Prolonged
- Interventions
- Other: Saline
- Registration Number
- NCT04299438
- Lead Sponsor
- Lisa Levine
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 164
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propranolol Propranolol Hydrochloride IV Propranolol - 2mg; one possible repeat dose ≥2 hours later Placebo Saline Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later
- Primary Outcome Measures
Name Time Method Mode of Delivery From enrollment into the trial until delivery. Number of participants with a cesarean delivery
- Secondary Outcome Measures
Name Time Method Maternal Morbidity from delivery through 4 weeks postpartum Number of participants with 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death
Neonatal Morbidity from delivery through hospital discharge, usually 2-4 days 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
Postpartum Hemorrhage from time of delivery through hospital discharge, usually 2-4 days Amount of blood loss measured in mL
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
Chorioamnionitis from start of labor through delivery Number of participants with chorioamnionitis
Trial Locations
- Locations (2)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States