[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657373":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":48,"studyPopulation":51,"armGroups":48,"interventions":52,"overallOfficials":48,"centralContacts":48,"locations":57,"responsibleParty":73,"collaborators":48,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":48,"enrollmentInfo":85,"targetDuration":48,"studyType":88,"phases":48,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":95,"whyStopped":48,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Pregnolia AG","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Cervical Stiffness Index (CSI), in mbar","To determine the value of CSI, as measured by the Pregnolia System, in a Czech cohort of women presenting with symptoms of PTL.","22+0 - 35+6 gestational weeks",[14,18,21,24,27,29],{"measure":15,"description":16,"timeFrame":17},"Patient delivery data: gestational age at birth","Gestational at birth (weeks)","Up to 4 weeks after delivery",{"measure":19,"description":20,"timeFrame":17},"Patient delivery data: time to delivery","Time from cervical stiffness measurement to delivery (days)",{"measure":22,"description":23,"timeFrame":17},"Patient delivery data: onset of labor","Onset of labor: spontaneous, induction, primary C-section, other",{"measure":25,"description":26,"timeFrame":17},"Patient delivery data: mode of delivery","Mode of delivery: spontaneous vaginal delivery, induced vaginal delivery, C-section, instrumented",{"measure":28,"description":28,"timeFrame":12},"Transvaginal cervical length",{"measure":30,"description":31,"timeFrame":32},"Cervical Stiffness Index (CSI) at discharge","Optional measurement of CSI at discharge","At discharge (from 22+0 weeks onwards)",[34,37,40,43],{"measure":35,"description":36,"timeFrame":17},"Health economics data: duration of hospitalization","Duration of hospitalization (days)",{"measure":38,"description":39,"timeFrame":17},"Health economics data: NICU length of stay","NICU length of stay (days)",{"measure":41,"description":42,"timeFrame":17},"Health economics data: medications\u002Finterventions","Medications\u002Finterventions during pregnancy until delivery",{"measure":44,"description":45,"timeFrame":46},"Device-related adverse events","Device-related adverse events (incidence, severity, and seriousness)","22+0 gestational weeks to up to 4 weeks after delivery",{"allocation":48,"interventionModel":48,"interventionModelDescription":48,"primaryPurpose":48,"observationalModel":49,"timePerspective":50,"maskingInfo":48},null,"COHORT","PROSPECTIVE","Women with singleton pregnancies at 22+0 - 35+6 weeks gestation presenting signs and symptoms for threatened preterm labor.",[53],{"type":54,"name":55,"description":56,"armGroupLabels":48,"otherNames":48},"DEVICE","Pregnolia System","The Pregnolia System is a CE-marked medical device using the aspiration method. It quantifies reliably cervical stiffness by measuring the amount of vacuum required to deform cervical tissue.",[58],{"facility":59,"status":48,"city":60,"state":48,"zip":48,"country":61,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Institute for the Care of Mother and Child","Prague","Czechia",{"type":63,"coordinates":64},"Point",[65,66],14.42076,50.08804,{"lat":66,"lon":65},[69],{"name":70,"role":71,"phone":48,"phoneExt":48,"email":72},"Lubomír Hašlík","CONTACT","lubomir.haslik@upmd.eu",{"type":74,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100657373","cervical-stiffness-in-women-with-threatened-preterm-labor-a-czech-cohort-study-100657373",false,"NCT07840235","Cervical Stiffness in Women With Threatened Preterm Labor","Cervical Stiffness in Women With Threatened Preterm Labor: a Czech Cohort Study","CZECH-TPTL","Inclusion Criteria:\n\n* Singleton gestation\n* Aged ≥18 years\n* Able to give informed consent\n* Between 22 weeks, 0 days and 35 weeks, 6 days of gestation\n* An ultrasound performed within 6 hours prior to CSI assessment, or after CSI assessment, showing a closed external cervical os and absence of bulging of the membranes into the cervical canal. If ultrasound was conducted by referring hospital, it shall be repeated as part of the study.\n* At speculum or vaginal examination: cervical dilation less than 3 cm and no membrane seen or palpated.\n* Intact membranes\n* Sign and\u002For symptoms of threatened preterm labor: one or more of the following:\n\n  * Abdominal pain or cramps\n  * Uterine contractions, felt or unfelt\n  * Bloody show (\"spotting\" or light bleeding)\n  * Pelvic pressure\n  * Low back pain (continuous or intermittent)\n\nExclusion Criteria:\n\n* Signs of imminent labor such as strong, painful and intense contractions (strong suspicion of true labor).\n* Cervical dilatation ≥ 3 cm\n* Signs of intrauterine infection \u002F amnionitis\n* Obstetric indication for immediate delivery (advanced labor, cord prolapse, placenta abruption, signs of fetal distress)\n* Confirmed fetal abnormality\n* Fetal death\n* Known or suspected rupture of membranes\n* Confirmed vasa \u002F placenta previa\n* Severe active vaginal bleeding\n* Light bleeding that cannot be stopped\n* Cerclage or pessary in place\n* Müllerian anomalies\n* Female genital mutilation","FEMALE","18 Years",{"count":86,"type":87},100,"ESTIMATED","OBSERVATIONAL","Women giving birth prematurely due to spontaneous preterm labor may exhibit signs and symptoms of preterm labor (PTL) which are mostly nonspecific. Among all women presenting in emergency with some complaints suggesting preterm labor, only about 10% will give birth within 7 days.\n\nCurrent clinical methods to improve diagnosis of PTL include digital examination, transvaginal cervical length assessment or the use of biomarkers; however, none of these methods have high accuracy, and it is therefore important to improve diagnosis of spontaneous PTL.\n\nThere is a need for more accurate methods and tools to correctly identify imminent preterm labor in order to avoid unnecessary hospital admissions and therapy, as well as give better care for those women truly in PTL who need focused attention.\n\nRecently, cervical stiffness has been evaluated as a novel biomarker for prediction of spontaneous preterm birth. The Pregnolia System is a new CE-marked device for measuring cervical stiffness in a simple and quantitative way, providing clinicians with an immediate and actionable result.\n\nThe device has been evaluated for risk stratification of women at higher risk of delivering prematurely in some European countries. However, data on cervical stiffness in Czech healthcare setting are lacking, and these findings have not yet been confirmed in this population.\n\nIn this cohort study, the investigators aim to assess cervical stiffness in women with threatening PTL in a Czech cohort and to evaluate its association with delivery outcomes. Ultimately, the investigators seek to determine whether findings from other European populations can be reproduced in a Czech setting.",[91,92],"Preterm Labor","Preterm Birth",[94],"cervical stiffness","NOT_YET_RECRUITING","2026-09-28",{"date":98,"type":99},"2026-10-01","ACTUAL",{"date":98,"type":87},{"date":102,"type":87},"2027-12-31",{"name":5,"class":6},1]