Papaverine for Prevention of Perineal Trauma
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
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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.
|
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Comparatore placebo: Placebo Group
Participants randomized to this arm will receive placebo consisting of 100 mL normal saline administered intravenously at full cervical dilatation during labor.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rate of Perineal Trauma Requiring Suturing
Lasso di tempo: 1 Day
|
The rate of perineal trauma requiring suturing following vaginal delivery, including first-, second-, third-, and fourth-degree perineal tears.
|
1 Day
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rate of Obstetric Anal Sphincter Injuries (OASIS)
Lasso di tempo: 1 day
|
Rate of third- and fourth-degree perineal tears diagnosed following vaginal delivery.
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1 day
|
|
Rate of Episiotomy
Lasso di tempo: 1 day
|
Rate of mediolateral episiotomy performed during delivery.
|
1 day
|
|
Mode of Delivery
Lasso di tempo: 1 day
|
Mode of delivery including spontaneous vaginal delivery, operative vaginal delivery, or cesarean delivery.
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1 day
|
|
Postpartum Hemorrhage (PPH)
Lasso di tempo: 1 day
|
Rate of postpartum hemorrhage diagnosed following delivery according to institutional criteria.
|
1 day
|
|
Manual Placental Removal
Lasso di tempo: 1 day
|
Need for manual placental removal following delivery.
|
1 day
|
|
Maternal Hemoglobin Drop
Lasso di tempo: 1 day
|
Difference between pre-delivery hemoglobin level and the lowest postpartum hemoglobin level measured during hospitalization.
|
1 day
|
|
Maternal Adverse Events
Lasso di tempo: 7 days
|
Maternal adverse effects including tachycardia, hypotension, nausea, vomiting, headache, and dry mouth following study drug administration.
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7 days
|
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Neonatal Outcomes
Lasso di tempo: 1 day
|
5-Minute Apgar Score
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1 day
|
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NICU Admission
Lasso di tempo: 7 days
|
Need for neonatal intensive care unit admission following birth.
|
7 days
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0015-26-NHR
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