Papaverine for Prevention of Perineal Trauma

NCT07641543 | Not Yet Recruiting DMC

• 1 other identifier: 0015-26-NHR
• Study Type: interventional
• Target: 412
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perineal Trauma; Obstetric Anal Sphincter Injury

Keywords

Papaverine; Perineal Trauma; Labor; Vaginal Delivery

Outcome Measures

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.

  1 Day

Secondary Outcomes (9)

• Rate of Obstetric Anal Sphincter Injuries (OASIS)

  1 day

• Rate of Episiotomy

  1 day

• Mode of Delivery

  1 day

• Postpartum Hemorrhage (PPH)

  1 day

• Manual Placental Removal

  1 day

Study Arms (2)

Papaverine Group

EXPERIMENTAL

Participants randomized to this arm will receive intravenous papaverine hydrochloride 80 mg diluted in 100 mL normal saline administered at full cervical dilatation during labor.

Drug: Papaverine Hydrochloride

Placebo Group

PLACEBO COMPARATOR

Participants randomized to this arm will receive placebo consisting of 100 mL normal saline administered intravenously at full cervical dilatation during labor.

Drug: Placebo

Interventions

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.

Papaverine Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous patients aged 18 years or older
• Singleton pregnancy
• Term pregnancy (37+0 to 42+0 weeks of gestation)
• Cephalic presentation
• Undergoing labor with at least with 2 cm cervical dilatation.
• Ability to provide written informed consent

You may not qualify if:

• Multiple gestation
• Major fetal congenital anomalies
• Contraindication to vaginal delivery
• Known hypersensitivity or allergy to papaverine hydrochloride
• Known supraventricular tachycardia (SVT)
• Maternal tachycardia (heart rate \>100 bpm) or clinically significant cardiac arrhythmia
• Known liver disease or hepatic dysfunction
• Active psychiatric condition impairing the ability to provide informed consent
• Inability to provide written informed consent
• Planned cesarean delivery

Sponsors & Collaborators

• Dr Raneen Abu Shqara: lead

MeSH Terms

Interventions

Papaverine

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, treating caregivers, investigators, and outcome assessors will be blinded to treatment allocation. Randomization codes will be maintained by designated nursing staff responsible for preparation of the study medication and not involved in clinical management or outcome assessment. Papaverine and placebo will be prepared in identical intravenous bags to ensure allocation concealment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: Participants will be randomized in a 1:1 ratio to receive either intravenous papaverine hydrochloride 80 mg diluted in 100 mL normal saline or placebo consisting of 100 mL normal saline at full cervical dilatation. Participants, caregivers, investigators, and outcome assessors will remain blinded to treatment allocation. Outcomes will be compared between the two parallel study arms.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 11, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): June 3, 2027
• Study Completion (Estimated): June 3, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share