[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656420":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":48,"studyPopulation":36,"armGroups":49,"interventions":62,"overallOfficials":36,"centralContacts":73,"locations":83,"responsibleParty":100,"collaborators":36,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":36,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":36,"maxAge":36,"enrollmentInfo":110,"targetDuration":36,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":86,"whyStopped":36,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Wolfson Medical Center","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Time From Study Infusion to Delivery","Time, measured in hours, from administration of the assigned study infusion (papaverine or placebo) to delivery.","From administration of the study infusion until delivery, assessed up to 48 hours",[14,18,21,24,28,32],{"measure":15,"description":16,"timeFrame":17},"Mode of Delivery","Mode of delivery, categorized as vaginal or cesarean delivery","From rupture of membranes until delivery, assessed up to 48 hours",{"measure":19,"description":20,"timeFrame":17},"Maternal Infectious Complications","Proportion of participants with maternal infectious complications",{"measure":22,"description":23,"timeFrame":17},"Postpartum Hemorrhage","Proportion of participants with postpartum hemorrhage",{"measure":25,"description":26,"timeFrame":27},"Apgar Score at 5 Minutes","Apgar score recorded 5 minutes after birth, ranging from 0 to 10","5 minutes after birth",{"measure":29,"description":30,"timeFrame":31},"Umbilical Cord pH Below 7.1","Proportion of neonates with umbilical cord blood pH below 7.1","At birth, based on umbilical artery cord blood sampling",{"measure":33,"description":34,"timeFrame":35},"Neonatal Infection","Proportion of neonates diagnosed with neonatal infection","From birth through neonatal hospital discharge, assessed up to 7 days after birth",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":36,"timePerspective":36,"maskingInfo":42},"RANDOMIZED","PARALLEL","Participants were randomized in a 1:1 ratio to receive intravenous papaverine or placebo in two parallel groups.","TREATMENT",{"masking":43,"maskingDescription":44,"whoMasked":45},"DOUBLE","Treatment allocation was known only to one study team member who prepared the study infusions according to the randomization list. Participants, treating clinicians, investigators, and personnel involved in outcome assessment remained blinded to treatment allocation. Study infusions were prepared in identical 100-mL normal saline bags and were labeled without revealing group assignment.",[46,47],"PARTICIPANT","CARE_PROVIDER","Women hospitalized in the labor and delivery unit with term premature rupture of membranes at 37 weeks of gestation or later are screened for participation. Eligible participants have no active contractions, cervical dilation of less than 2 cm, vertex presentation, and a duration of membrane rupture between 2 and 12 hours.\n\nFollowing informed consent, participants are randomized in a 1:1 ratio to receive intravenous papaverine 80 mg diluted in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo. The study infusion is administered one hour after initiation of oxytocin.\n\nTreatment allocation is blinded. One study-team member prepares the study solution according to the randomization table, while the remainder of the study team remains blinded to treatment allocation. The primary outcome is the interval from study infusion to delivery.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Papaverine","EXPERIMENTAL","Participants received intravenous papaverine 80 mg diluted in 100 mL of 0.9% normal saline.",[55],"Drug: Papaverine",{"label":57,"type":58,"description":59,"interventionNames":60},"Placebo","PLACEBO_COMPARATOR","Participants received 100 mL of intravenous 0.9% normal saline as placebo.",[61],"Drug: Normal Saline Placebo Infusion",[63,67],{"type":64,"name":51,"description":65,"armGroupLabels":66,"otherNames":36},"DRUG","Papaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion.",[51],{"type":64,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Normal Saline Placebo Infusion","100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion.",[57],[72],"0.9% Sodium Chloride",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":36,"email":78},"Eliel Kedar Sade, MD","CONTACT","+972-52-6008068","elielbob@gmaill.com",{"name":80,"role":76,"phone":81,"phoneExt":36,"email":82},"Ornit Cohen","+972-3-5028399","ornitc@wmc.gov.il",[84],{"facility":85,"status":86,"city":87,"state":36,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"The Edith Wolfson Medical Center","RECRUITING","Holon","5822012","Israel","IL",{"type":92,"coordinates":93},"Point",[94,95],34.77918,32.01034,{"lat":95,"lon":94},[98,99],{"name":75,"role":76,"phone":77,"phoneExt":36,"email":78},{"name":80,"role":76,"phone":81,"phoneExt":36,"email":82},{"type":101,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100656420","intravenous-papaverine-for-term-prelabor-rupture-of-membranes-100656420",false,"NCT07826533","Intravenous Papaverine for Term Prelabor Rupture of Membranes","The Effect of Papaverine on Labour in Term Premature Rupture of Membranes (PROM)","Inclusion Criteria:\n\n* Age ≥18 years\n* Gestational age ≥37 weeks with term PROM\n* No active contractions\n* Cervical dilation \\\u003C2 cm\n* Vertex presentation\n* PROM duration between 2 and 12 hours\n\nExclusion Criteria:\n\n* Previous cesarean delivery\n* Contraindication to vaginal delivery\n* Known fetal malformation\n* Known allergy to papaverine\n* Cardiac arrhythmia\n* Glaucoma\n* Hepatitis or other hepatic disease\n* Atrioventricular (AV) block\n* Congestive heart disease\n* Recent ischemic heart disease\n* Increased intracranial pressure\n* Active labor, defined as cervical dilation ≥6 cm\n* Contraindication to uterine relaxation, including significant uterine bleeding or fetal distress Active infection or chorioamnionitis Use of medications with potentially hazardous interactions with papaverine","FEMALE",{"count":111,"type":112},200,"ESTIMATED","INTERVENTIONAL",[115],"NA","This randomized, double-blind, placebo-controlled trial evaluates whether intravenous papaverine, administered as an adjunct to oxytocin, shortens the time to delivery in women with term premature rupture of membranes (PROM). Participants are randomized in a 1:1 ratio to receive either intravenous papaverine 80 mg in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo, administered one hour after initiation of oxytocin. The primary outcome is the interval from study infusion to delivery. Secondary outcomes include mode of delivery and maternal and neonatal outcomes.",[118],"Premature Rupture of Fetal Membranes",[120,121,51,122,123],"Term PROM","Premature rupture of membranes","Labor induction","Oxytocin","2026-09-14",{"date":126,"type":127},"2026-09-17","ACTUAL",{"date":129,"type":127},"2025-03-20",{"date":131,"type":112},"2027-04-21",{"name":5,"class":6},1]