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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Papaverine Hydrochloride

    Drug

    Intravenous 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

    Drug

    Placebo 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

412 Participants
are divided into 2 treatment groups
Group A: Papaverine GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 Day

Secondary outcomes

1

Rate of Obstetric Anal Sphincter Injuries (OASIS)

Rate of third- and fourth-degree perineal tears diagnosed following vaginal delivery.

Time frame
1 day
2

Rate of Episiotomy

Rate of mediolateral episiotomy performed during delivery.

Time frame
1 day
3

Mode of Delivery

Mode of delivery including spontaneous vaginal delivery, operative vaginal delivery, or cesarean delivery.

Time frame
1 day
4

Postpartum Hemorrhage (PPH)

Rate of postpartum hemorrhage diagnosed following delivery according to institutional criteria.

Time frame
1 day

Other outcomes

Locations

This trial has no 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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