[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653877":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":27,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":56,"collaborators":13,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":13,"enrollmentInfo":68,"targetDuration":13,"studyType":71,"phases":72,"briefSummary":73,"conditions":74,"keywords":13,"overallStatus":44,"whyStopped":13,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Microbiological analysis of amniotic fluid by next generation analysis","Presence and concentrations of bacteria in amniotic fluid","From date of enrollment to the end of pregnancy (up to 9 months)",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":24,"interventionNames":25},"cases and controls","EXPERIMENTAL","Women with diagnosis of short cervix before 24 weeks of gestational age undergone to amniocentesis (cases group 1), women with premature rupture of membranes undergone to amniotic fluid collection by sterile cervical aspiration via the vagina (cases group 2) and healthy women with an uncomplicated obstetric history undergoing amniocentis for genetic diagnosis (controls)",[26],"Other: amniotic fluid collection",[28],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":13},"amniotic fluid collection","Amniotic fluid by amniocentesis or by sterile cervical aspiration via the vagina",[22],[33],{"name":34,"affiliation":5,"role":35},"Chiara Tersigni","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":13,"email":40},"CONTACT","+390630157546","chiara.tersigni@policlinicogemelli.it",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":13},"Fondazione Policlinico Universitario A. Gemelli IRCCS","RECRUITING","Roma","RM","00168","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],11.10642,44.99364,{"lat":54,"lon":53},{"type":57,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100653877","microbiological-and-biochemical-profiling-of-amniotic-fluid-in-women-with-short-cervix-or-premature-rupture-of-membranes-100653877",false,"NCT07792083","Microbiological and Biochemical Profiling of Amniotic Fluid in Women With Short Cervix or Premature Rupture of Membranes","CIPRO","Inclusion Criteria:\n\n* Singleton pregnancy;\n* Age \\> 18 years;\n* Pregnant women diagnosed with cervical incompetence (via ultrasound criteria) with cervical length \\\u003C24 mm, before 24 weeks of gestational age, with intact amniotic membranes and absence of uterine contractions;\n* Pregnant women diagnosed with p-PROM (via clinical criteria and\u002For with a qualitative immunoassay vaginal test) before 34 weeks of gestational age;\n* Healthy pregnant women with uncomplicated obstetric history who underwent amniocentesis to exclude chromosomal abnormalities;\n* Informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Multiple pregnancy;\n* Patients with contraindications to amniocentesis, including severe bleeding disorders or placenta previa;\n* Patients with known fetal anomalies incompatible with life;\n* Patients with sepsis or clinical diagnosis of chorioamnionitis;",true,"FEMALE","18 Years",{"count":69,"type":70},300,"ESTIMATED","INTERVENTIONAL",[15],"This study aims at assessing the efficacy, reliability, and clinical impact of Amniotic Fluid analysis by Nanopore DNA sequencing compared to the standard bacterial cultures in detecting intra-amniotic\u002Finflammation in patients with short cervix or premature rupture of membranes.",[75,76],"Short Cervix","PROM, Preterm (Pregnancy)","2026-08-27",{"date":79,"type":80},"2026-08-28","ACTUAL",{"date":82,"type":80},"2025-12-23",{"date":84,"type":70},"2030-12",{"name":5,"class":6},1]