[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580311":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":21,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":21,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":21,"enrollmentInfo":67,"targetDuration":21,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":39,"whyStopped":21,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"GE Healthcare","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Twin Monitoring - All Subjects","EXPERIMENTAL","Pregnant women of ≥30 0\u002F7 weeks gestation will undergo one 40-minute monitoring session utilizing the investigational device with two Doppler transducers (FHR 1 and FHR 2) following M- mode fetal ultrasound imaging confirming fetal presentation, fetal lie, visualization of fetal heart rates of each fetus and documentation. During the monitoring sessions, maternal pulse rate (MPR) will be monitored using a SpO2 sensor and the investigator shall be present to adjust the transducers as needed to maintain a continuous FHR tracing.",[13,14],"Device: Investigational Fetal Monitor","Device: Ultrasound Imaging Device",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Investigational Fetal Monitor","Investigational Fetal Monitoring Device Device is a multi-parameter maternal fetal monitor that is intended to monitor, store, display, transmit, and generate alarms for non-invasive and invasive clinical parameters of pregnant women and fetuses (singleton and twin), during the antepartum, intrapartum, and postpartum period.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Ultrasound Imaging Device","The Ultrasound imaging device is a general-purpose diagnostic ultrasound system for use in measurement, display and analysis of the human body and fluid.",[9],[27],{"name":28,"affiliation":29,"role":30},"Monica Rabanal, NP","Element Materials Technology","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Amie Research Program Integrator","CONTACT","816-719-6765","Amie.Robinson@gehealthcare.com",[38],{"facility":29,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Louisville","Colorado","80027","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-105.13193,39.97776,{"lat":49,"lon":48},[52,55],{"name":28,"role":34,"phone":53,"phoneExt":21,"email":54},"303-926-5432","Monical.Rabanal@element.com",{"name":28,"role":30,"phone":21,"phoneExt":21,"email":21},{"type":57,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100580311","maternal-fetal-device-performance-twins-100580311",false,"NCT06835647","Maternal Fetal Device Performance Twins","Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent.\n2. Twin pregnancy.\n3. Aged 18+.\n4. Greater than or equal to 30 0\u002F7 weeks gestation.\n5. Patient has none of the exclusion criteria.\n\nExclusion Criteria:\n\n1. Non-twin pregnancy.\n2. Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.\n3. Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.\n4. Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier.","FEMALE","18 Years",{"count":68,"type":69},15,"ESTIMATED","INTERVENTIONAL",[72],"NA","Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which support clinical decision making for pregnant women and assesses the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data by collecting simultaneous, continuous, external, distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the new maternal fetal monitoring investigational device and a marketed ultrasound imaging device.",[75],"Pregnancy",[75,77],"Twins","2025-07-10",{"date":80,"type":81},"2025-07-15","ACTUAL",{"date":83,"type":81},"2025-01-21",{"date":85,"type":69},"2025-12-31",{"name":5,"class":6},1]