Clinical Trial

Papaverine for Prevention of Perineal Trauma

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Summary
Perineal trauma is a common complication of vaginal delivery, particularly among primiparous patients, and may result in short- and long-term maternal morbidity, including pain, dyspareunia, and pelvic floor dysfunction. Papaverine hydrochloride, a smooth muscle relaxant with vasodilatory properties, has been shown to improve tissue relaxation and has been used safely in obstetric settings. This prospective randomized double-blind placebo-controlled study aims to evaluate whether intrapartum intravenous papaverine hydrochloride (80 mg), administered at full cervical dilatation, reduces the rate of perineal trauma among primiparous patients undergoing vaginal delivery. Eligible participants will be randomized in a 1:1 ratio to receive either intravenous papaverine hydrochloride or placebo (normal saline). Maternal, obstetric, and neonatal outcomes, including the rate and severity of perineal trauma, obstetric anal sphincter injuries (OASIS), postpartum hemorrhage, and neonatal outcomes, will be assessed.
Trial Details
NCT Number NCT07641543
Lead Sponsor Dr Raneen Abu Shqara
Conditions Perineal Trauma, Obstetric Anal Sphincter Injury
Enrollment 412 participants
Start Date 2026-06-03
Primary Completion 2027-06-03 (estimated)
Study Completion 2027-06-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-11