[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"threatened-preterm-labor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:threatened-preterm-labor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100590511","fb-ct2-includes-two-prospective-multi-centre-studies-with-a-medical-device-in-hospital-settings-a-randomized-dual-arm-open-label-pilot-study-in-spain-followed-by-a-single-arm-non-randomized-open-label-international-pivotal-study-100590511",false,"NCT06968364","FB-CT2 Includes Two Prospective, Multi-centre Studies With a Medical Device in Hospital Settings: a Randomized, Dual-arm, Open-label Pilot Study in Spain, Followed by a Single-arm, Non-randomized, Open-label International Pivotal Study","Evaluation of the Safety and the Preterm Birth Predictive Capacity of the Clinical Investigation Device 'Cervisense TPTL': an International Clinical Study","FB-CT2","Inclusion Criteria:\n\n* Female ≥18 years\n* Singleton pregnancy\n* Live fetus, 28w+0d-36w+6d GA\n* Intact membranes\n* Cervical dilatation \\\u003C2 cm\n* Signed informed consent\n* Regular uterine contractions (≥8\u002F60 min) (Pivotal only)\n\nExclusion Criteria:\n\n* Latex allergy\n* Prolapsed membranes\n* Fetal malformation\n* Fetal infection\n* Vaginal bleeding (severe or persistent)\n* Cervical cerclage\n* Müllerian anomalies\n* Pessary use\n* Regular uterine contractions (reported by patient) (Pilot only)\n* History of preterm birth or TPTL (Pilot only)\n* Vasa\u002Fplacenta previa (Pilot only)\n* Gastrointestinal or urinary infections (Pivotal only)",true,"FEMALE","18 Years",{"count":21,"type":22},457,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to evaluate the safety and the ability of a clinical investigation device (Cervisense TPTL) to predict the risk of spontaneous preterm birth in pregnant women with symptoms of threatened preterm labor (TPTL), between 28+0 and 36+6 weeks of gestation. The main questions it aims to answer are:\n\nDoes the Cervisense TPTL device predict spontaneous preterm birth within 7 days?\n\nIs the device safe and technically reliable in a hospital setting?\n\nResearchers will conduct a Pilot Study (randomized, dual-arm) followed by a Pivotal Study (single-arm) to assess technical feasibility and predictive performance.\n\nParticipants will undergo an intravaginal measurement of cervical stiffness using the Cervisense Intravaginal Probe. They will be followed for 14 days after the assessment to record delivery outcomes and any adverse events.",[28],"Threatened Preterm Labor","RECRUITING","2025-05-05",{"date":32,"type":33},"2025-05-13","ACTUAL",{"date":35,"type":22},"2025-05-10",{"date":37,"type":22},"2027-04-01",{"name":39,"class":40},"Ultrasound-Innovation Medtech, S.L.","INDUSTRY",14,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100577131","blood-glucose-in-pregnant-non-diabetic-women-during-treatment-with-betamethasone-for-fetal-lung-maturation-100577131","NCT06794307","Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation","Blood Glucose Levels in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation","Inclusion Criteria:\n\n* Pregnant in gestational week 24+0 - 34+0 admitted with symptoms of threatened preterm birth:\n\n  * Premature contractions and shortening of the cervix, or\n  * Preterm premature rupture of membranes.\n* Treatment with betamethasone for fetal lung maturation is planned, or started (maximum 4 hours before inclusion)\n* Age over 18 years\n* Read and understand Danish\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Diabetes\n* Pre-existing maternal use of medications that affect glucose metabolism",{"count":50,"type":22},25,"6 Months","OBSERVATIONAL","In case of threatening preterm birth, it is standard to recommend treatment with betamethasone to accelerate fetal lung maturation. In pregnant women with diabetes, treatment with betamethasone can lead to significant hyperglycemia, which may cause hypoglycemia in the neonate. Changes in blood glucose in non-diabetic women are less investigated. In this study we aim to examine changes in maternal blood glucose levels in non-diabetic women, during treatment with betamethasone, by continuous glucose monitoring.\n\nHypotheses:\n\nAdministration of betamethasone induce significant hyperglycemia in non-diabetic pregnant women during treatment.",[55,56,57,28],"Preterm Birth","Hyperglycemia","Neonatal Hypoglycemia",[59,60,61,62],"Preterm birth","Betamethasone","Continuous glucose monitoring","Antenatal corticosteroids","2025-01-20",{"date":65,"type":33},"2025-01-27",{"date":67,"type":33},"2024-11-20",{"date":69,"type":22},"2026-01",{"name":71,"class":72},"University of Aarhus","OTHER",1]