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Papaverine for Prevention of Perineal Trauma

6 juni 2026 bijgewerkt door: Dr Raneen Abu Shqara

The Impact of Intrapartum Papaverine 80 mg on Perineal Trauma Among Primiparous Women: a Prospective Randomized Double-blind Study.

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Perineal trauma is a frequent complication of vaginal birth and is particularly common among primiparous patients. Rates of second-degree perineal tears among nulliparous women have been reported to range between 35% and 78%, while obstetric anal sphincter injuries (OASIS) occur in approximately 0.7% to 2% of vaginal deliveries. Perineal trauma may result in substantial maternal morbidity, including postpartum pain, dyspareunia, pelvic floor dysfunction, urinary or anal incontinence, and impaired quality of life.

Several intrapartum interventions have been investigated to improve perineal tissue elasticity and reduce birth-related trauma, including warm perineal compresses, perineal massage, and active perineal protection techniques. However, pharmacological approaches aimed at enhancing tissue relaxation during labor remain poorly studied.

Papaverine hydrochloride is a smooth muscle relaxant with vasodilatory properties that acts directly on smooth muscle fibers. In obstetric settings, papaverine has been associated with improved cervical ripening and shorter labor duration without significant maternal or neonatal adverse effects. Due to its pharmacological effects on tissue relaxation and vascular perfusion, papaverine may potentially reduce resistance of the perineal tissues during childbirth and consequently decrease the rate and severity of perineal trauma.

Retrospective data from the investigators' institution, including 4,939 primiparous patients, demonstrated lower rates of first- and second-degree perineal tears among women who received intrapartum papaverine. However, because of the retrospective nature of these findings, causal conclusions cannot be established, and prospective randomized evaluation is warranted.

The objective of the present study is to determine whether intravenous papaverine hydrochloride (80 mg), administered at full cervical dilatation, reduces the rate of perineal trauma among primiparous patients undergoing vaginal delivery.

This study is designed as a prospective, randomized, double-blind, placebo-controlled trial. Eligible 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 (100 mL normal saline) following complete cervical dilatation. Participants, treating physicians, and outcome assessors will remain blinded to treatment allocation.

The primary outcome will be the rate of perineal trauma requiring suturing following vaginal delivery. Secondary outcomes will include the rate of OASIS, episiotomy, mode of delivery, postpartum hemorrhage, manual placental removal, maternal adverse effects, and neonatal outcomes including birthweight, 5-minute Apgar score, umbilical cord pH, and neonatal intensive care unit admission

Studietype

Ingrijpend

Inschrijving (Geschat)

412

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Papaverine Group
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.
Geneesmiddel: Papaverine Hydrochloride
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-vergelijker: Placebo Group
Participants randomized to this arm will receive placebo consisting of 100 mL normal saline administered intravenously at full cervical dilatation during labor.
Geneesmiddel: Placebo
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of Perineal Trauma Requiring Suturing
Tijdsspanne: 1 Day
The rate of perineal trauma requiring suturing following vaginal delivery, including first-, second-, third-, and fourth-degree perineal tears.
1 Day

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of Obstetric Anal Sphincter Injuries (OASIS)
Tijdsspanne: 1 day
Rate of third- and fourth-degree perineal tears diagnosed following vaginal delivery.
1 day
Rate of Episiotomy
Tijdsspanne: 1 day
Rate of mediolateral episiotomy performed during delivery.
1 day
Mode of Delivery
Tijdsspanne: 1 day
Mode of delivery including spontaneous vaginal delivery, operative vaginal delivery, or cesarean delivery.
1 day
Postpartum Hemorrhage (PPH)
Tijdsspanne: 1 day
Rate of postpartum hemorrhage diagnosed following delivery according to institutional criteria.
1 day
Manual Placental Removal
Tijdsspanne: 1 day
Need for manual placental removal following delivery.
1 day
Maternal Hemoglobin Drop
Tijdsspanne: 1 day
Difference between pre-delivery hemoglobin level and the lowest postpartum hemoglobin level measured during hospitalization.
1 day
Maternal Adverse Events
Tijdsspanne: 7 days
Maternal adverse effects including tachycardia, hypotension, nausea, vomiting, headache, and dry mouth following study drug administration.
7 days
Neonatal Outcomes
Tijdsspanne: 1 day
5-Minute Apgar Score
1 day
NICU Admission
Tijdsspanne: 7 days
Need for neonatal intensive care unit admission following birth.
7 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dr Raneen Abu Shqara

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

3 juni 2026

Primaire voltooiing (Geschat)

3 juni 2027

Studie voltooiing (Geschat)

3 juni 2027

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 juni 2026

Eerst geplaatst (Werkelijk)

11 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

6 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0015-26-NHR

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data (IPD) will not be made publicly available due to participant privacy considerations and institutional data protection policies. De-identified data may be available from the principal investigator upon reasonable request and subject to institutional review and approval.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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