About this trial
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.
Eligibility criteria
Qualifiers
Primiparous patients aged 18 years or older
Singleton pregnancy
Term pregnancy (37+0 to 42+0 weeks of gestation)
Cephalic presentation
Disqualifiers
Multiple gestation
Major fetal congenital anomalies
Contraindication to vaginal delivery
Known hypersensitivity or allergy to papaverine hydrochloride
Trial design
Treatments tested in this trial
- Papaverine Hydrochloride
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Dr Raneen Abu Shqara
Lead sponsor
Western Galilee Hospital-Nahariya
Sponsor institution