[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615731":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":57,"collaborators":20,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Raydiant Oximetry, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dual Sensor Recipients","EXPERIMENTAL","Women in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems.",[13],"Device: Fetal Pulse Oximetery",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Fetal Pulse Oximetery","Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Perry S Barrilleaux, MD","Louisiana State University Health Shreveport","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Shannon Phillips, RN, BSN","CONTACT","318-675-7207","shannon.phillips@lsuhs.edu",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":20},"Chelsie Liegey, LPC, RN","318-675-7064",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"LSU Health Science Center-Shreveport","RECRUITING","Shreveport","Louisiana","71101","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-93.75018,32.52515,{"lat":48,"lon":47},[51,53,56],{"name":52,"role":29,"phone":30,"phoneExt":20,"email":31},"Shannon Phillips, RN",{"name":54,"role":29,"phone":20,"phoneExt":34,"email":55},"Chelsie Liegey, RN","chelsie.liegey@lsuhs.edu",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":58,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100615731","dual-system-study-transvaginal-fetal-pulse-oximetry-measurement-systems-100615731",false,"NCT07296419","Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems","Inclusion Criteria:\n\n1. Willing and capable of providing informed consent.\n2. Age \\> 18 years.\n3. Gestational age \\> 36 weeks.\n4. Singleton pregnancy.\n5. Vertex presentation,\n6. In latent or active labor,\n7. Category I or II tracings,\n8. Epidural anesthesia, and\n9. Ruptured amniotic sac with cervical dilation of \\>2 cm and a station of -2 or lower.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years.\n2. Gestational age \\\u003C 36 weeks\n3. Multiple gestation\n4. Nonvertex fetal presentation\n5. Suspected vasa previa\n6. Category III CTG tracing\n7. Fetal anomalies and\u002For chromosomal disorders\n8. Chorioamnionitis\n9. Placenta previa\n10. HIV, genital Herpes, or other infection precluding transvaginal monitoring\n11. Unable to provide informed consent (e.g., cognitively impaired)\n12. Low anterior placenta, or\n13. Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures.",true,"FEMALE","18 Years",{"count":69,"type":70},15,"ESTIMATED","INTERVENTIONAL",[73],"NA","The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.",[76,77],"Fetal Hypoxia","Fetal Acidemia","2025-12-18",{"date":80,"type":81},"2025-12-22","ACTUAL",{"date":83,"type":81},"2025-12-08",{"date":85,"type":70},"2026-04",{"name":5,"class":6},1]