[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659677":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":26,"interventions":38,"overallOfficials":13,"centralContacts":13,"locations":53,"responsibleParty":73,"collaborators":13,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":13,"enrollmentInfo":85,"targetDuration":13,"studyType":88,"phases":13,"briefSummary":89,"conditions":90,"keywords":13,"overallStatus":93,"whyStopped":13,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Medical University of Graz","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":14},[9],{"measure":10,"description":11,"timeFrame":12},"FIRS","Interleukin-6 levels above 11 pg\u002Fml and\u002For histological evidence of funisitis","During the first week of life of the newborn",null,[15,18],{"measure":16,"description":17,"timeFrame":12},"Activation status of the neonatal immune system","* Ratio of pro- versus antiinflammatory leukocytes\n* Ratio of pro- versus antiinflammatory cytokines",{"measure":19,"description":17,"timeFrame":20},"Activation of the maternal immune system","From enrollment until birth",{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":22,"timePerspective":23,"maskingInfo":13},"COHORT","PROSPECTIVE","The focus is on ultrasound assessments of the fetal thymus, spleen, and liver, as well as fetal echocardiography, as potential index parameters for predicting a clinical infection or fetal inflammatory response syndrome (FIRS) in the newborn.","Pregnant women who have been admitted to the Clinical Department of Obstetrics at the Medical University of Graz for monitoring.",[27,34],{"label":28,"type":13,"description":29,"interventionNames":30},"Study group","Patients with premature rupture of membranes\u002Fpreterm parturation \\\u003C37 weeks of gestation",[31,32,33],"Other: Fetal ultrasound","Other: blood draw","Other: vaginal swab",{"label":35,"type":13,"description":36,"interventionNames":37},"Control group","Patients with term parturation (37+0 to 41+3 weeks of pregnancy, without premature rupture of membranes\u002Fpreterm parturation)",[32],[39,43,47,50],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"Fetal ultrasound","Fetal ultrasound (spleen, liver, thymus, heart)",[28],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":13},"blood draw","maternal",[35,28],{"type":6,"name":44,"description":48,"armGroupLabels":49,"otherNames":13},"umbilical cord",[35,28],{"type":6,"name":51,"description":45,"armGroupLabels":52,"otherNames":13},"vaginal swab",[28],[54],{"facility":55,"status":13,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Medical University of Graz Department of Obstetrics and Gynecology","Graz","Styria","8010","Austria","AT",{"type":62,"coordinates":63},"Point",[64,65],15.44197,47.06733,{"lat":65,"lon":64},[68],{"name":69,"role":70,"phone":71,"phoneExt":13,"email":72},"Herbert Fluhr","CONTACT","+43 316 385 17069","herbert.fluhr@medunigraz.at",{"type":74,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659677","preterm-parturation-study-100659677",false,"NCT07869160","Preterm Parturation Study","Preterm Parturation (PrePart) Studie","PrePart","Inclusion Criteria:\n\n* Preterm rupture of membranes between 20+0 and 36+6 weeks of gestation\n* Expectant management with the goal of providing the highest level of neonatal care\n* Maternal age 18 years or older\n* Singleton pregnancy\n\nExclusion Criteria:\n\n* Palliative care plan (neonatal \"comfort care\")\n* Maternal age under 18\n* Multiple pregnancy\n* Significant fetal genetic abnormalities or malformations\n* Underlying maternal (auto)immune conditions\n* Participation in other clinical trials","FEMALE","18 Years",{"count":86,"type":87},300,"ESTIMATED","OBSERVATIONAL","In this study (study group) non-invasively measured fetal parameters in pregnant patients with preterm premature rupture of membranes (PPROM) or preterm parturation (cervical dilation before 37+0 weeks of gestation) will be examined for their association with short-term neonatal outcomes as well as with specific hematological and immunological parameters of the newborn.\n\nThe control group includes pregnant women who are due to give birth around their due date (between 37+0 and 41+3 weeks of gestation, without premature rupture of membranes or preterm parturation).",[91,92],"Preterm Parturation","Preterm Premature Rupture of Membranes (PPROM)","NOT_YET_RECRUITING","2026-10-06",{"date":96,"type":97},"2026-10-09","ACTUAL",{"date":99,"type":87},"2027-01-01",{"date":101,"type":87},"2031-06",{"name":5,"class":6},1]