A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women given IV propranolol versus placebo for treatment of prolonged labor.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
164
2mg/mL vials
0.9% saline in vials matching the vials of the active drug
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Mode of Delivery
Number of participants with a cesarean delivery
Time frame: From enrollment into the trial until delivery.
Length of Labor
Time in hours from start of labor or induction of labor to delivery
Time frame: hours from start of labor or induction of labor to time of delivery
Postpartum Hemorrhage
Amount of blood loss measured in mL
Time frame: from time of delivery through hospital discharge, usually 2-4 days
Chorioamnionitis
Number of participants with chorioamnionitis
Time frame: from start of labor through delivery
Maternal Morbidity
Number of participants with 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death
Time frame: from delivery through 4 weeks postpartum
Neonatal Morbidity
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
Time frame: from delivery through hospital discharge, usually 2-4 days
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