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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Komparátor placeba: Placebo Group
Participants randomized to this arm will receive placebo consisting of 100 mL normal saline administered intravenously at full cervical dilatation during labor.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Rate of Perineal Trauma Requiring Suturing
Časové okno: 1 Day
|
The rate of perineal trauma requiring suturing following vaginal delivery, including first-, second-, third-, and fourth-degree perineal tears.
|
1 Day
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Rate of Obstetric Anal Sphincter Injuries (OASIS)
Časové okno: 1 day
|
Rate of third- and fourth-degree perineal tears diagnosed following vaginal delivery.
|
1 day
|
|
Rate of Episiotomy
Časové okno: 1 day
|
Rate of mediolateral episiotomy performed during delivery.
|
1 day
|
|
Mode of Delivery
Časové okno: 1 day
|
Mode of delivery including spontaneous vaginal delivery, operative vaginal delivery, or cesarean delivery.
|
1 day
|
|
Postpartum Hemorrhage (PPH)
Časové okno: 1 day
|
Rate of postpartum hemorrhage diagnosed following delivery according to institutional criteria.
|
1 day
|
|
Manual Placental Removal
Časové okno: 1 day
|
Need for manual placental removal following delivery.
|
1 day
|
|
Maternal Hemoglobin Drop
Časové okno: 1 day
|
Difference between pre-delivery hemoglobin level and the lowest postpartum hemoglobin level measured during hospitalization.
|
1 day
|
|
Maternal Adverse Events
Časové okno: 7 days
|
Maternal adverse effects including tachycardia, hypotension, nausea, vomiting, headache, and dry mouth following study drug administration.
|
7 days
|
|
Neonatal Outcomes
Časové okno: 1 day
|
5-Minute Apgar Score
|
1 day
|
|
NICU Admission
Časové okno: 7 days
|
Need for neonatal intensive care unit admission following birth.
|
7 days
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 0015-26-NHR
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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