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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Papaverine Hydrochloride
DrugIntravenous papaverine hydrochloride 80 mg diluted in 100 mL normal saline administered at full cervical dilatation during labor. The study medication will be administered following complete cervical dilatation and prior to delivery in primiparous patients undergoing vaginal birth.
Placebo
DrugPlacebo consisting of 100 mL normal saline administered intravenously at full cervical dilatation during labor. The placebo solution will be prepared in an identical manner to maintain blinding.
Treatment groups
Trial outcomes
Primary outcomes
Rate of Perineal Trauma Requiring Suturing
The rate of perineal trauma requiring suturing following vaginal delivery, including first-, second-, third-, and fourth-degree perineal tears.
Secondary outcomes
Rate of Obstetric Anal Sphincter Injuries (OASIS)
Rate of third- and fourth-degree perineal tears diagnosed following vaginal delivery.
Rate of Episiotomy
Rate of mediolateral episiotomy performed during delivery.
Mode of Delivery
Mode of delivery including spontaneous vaginal delivery, operative vaginal delivery, or cesarean delivery.
Postpartum Hemorrhage (PPH)
Rate of postpartum hemorrhage diagnosed following delivery according to institutional criteria.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr Raneen Abu Shqara
Lead sponsor
Western Galilee Hospital-Nahariya
Sponsor institution
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