[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643236":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":26,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":26,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":26},{"fullName":5,"class":6},"Western Galilee Hospital-Nahariya","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Papaverine Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Dr Raneen Abu Shqara","Dr.","100643236","papaverine-for-prevention-of-perineal-trauma-100643236",false,"NCT07641543","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.","Inclusion Criteria:\n\n* Primiparous patients aged 18 years or older\n* Singleton pregnancy\n* Term pregnancy (37+0 to 42+0 weeks of gestation)\n* Cephalic presentation\n* Undergoing labor with at least with 2 cm cervical dilatation.\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Multiple gestation\n* Major fetal congenital anomalies\n* Contraindication to vaginal delivery\n* Known hypersensitivity or allergy to papaverine hydrochloride\n* Known supraventricular tachycardia (SVT)\n* Maternal tachycardia (heart rate \\>100 bpm) or clinically significant cardiac arrhythmia\n* Known liver disease or hepatic dysfunction\n* Active psychiatric condition impairing the ability to provide informed consent\n* Inability to provide written informed consent\n* Planned cesarean delivery","FEMALE","18 Years","45 Years",{"count":46,"type":47},412,"ESTIMATED","INTERVENTIONAL",[50],"NA","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.\n\nThis 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.",[53,54],"Perineal Trauma","Obstetric Anal Sphincter Injury",[56,53,57,58],"Papaverine","Labor","Vaginal Delivery","NOT_YET_RECRUITING","2026-06-06",{"date":62,"type":63},"2026-06-11","ACTUAL",{"date":65,"type":47},"2026-06-03",{"date":67,"type":47},"2027-06-03",{"name":33,"class":6}]