Papaverine for Prevention of Perineal Trauma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorDr Raneen Abu Shqara

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

412 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Dr Raneen Abu Shqara

Lead sponsor

Western Galilee Hospital-Nahariya

Sponsor institution