[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582120":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":64,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":32,"enrollmentInfo":81,"targetDuration":32,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":40,"whyStopped":32,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Maxima Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Remote self-administered eCTG monitoring (using Nemo Remote®)","EXPERIMENTAL","Subjects will receive remote self-administered eCTG monitoring (using Nemo Remote®), daily in a Home@Hospital setting for 30-90 minutes, or at least twice weekly at the outpatient clinic.",[13],"Device: Remote eCTG",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Remote eCTG","Device: Remote eCTG monitoring\n\nA remote self-administered electrophysiological cardiotocography (eCTG) monitoring (using Nemo Remote®), daily in a Home@Hospital setting, or at least twice weekly at the outpatient clinic, between 32 and 37 weeks of pregnancy.",[9],[21],"NI-fECG",[23],{"name":24,"affiliation":25,"role":26},"Judith O.E.H. van Laar, MD, PhD","Máxima Medical Center, Technical University of Eindhoven","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Sofie van Weelden, MSc","CONTACT","+31408888384",null,"s.vanweelden@mmc.nl",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Judith O.E.H. van Laar, MD, PHD","+314-8888384","gynaecologie.secr@mmc.nl",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Veldhoven","North Brabant","5504DB","Netherlands","NL",{"type":47,"coordinates":48},"Point",[49,50],5.40278,51.41833,{"lat":50,"lon":49},[53,57,58,60,62],{"name":54,"role":30,"phone":55,"phoneExt":32,"email":56},"dr. Anke M. Nieuwesteeg","+31-408889528","anke.nieuwesteeg@mmc.nl",{"name":24,"role":26,"phone":32,"phoneExt":32,"email":32},{"name":29,"role":59,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"name":61,"role":59,"phone":32,"phoneExt":32,"email":32},"M. Beatrijs van der Hout - van der Jagt, MSc, PhD",{"name":63,"role":59,"phone":32,"phoneExt":32,"email":32},"Loes Monen, MD, PhD",{"type":26,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Judith van Laar","Principal Investigator",[68],{"name":69,"class":6},"Eindhoven University of Technology","100582120","feasibility-of-remote-ectg-monitoring-homehospital-in-complicated-pregnancies-100582120",false,"NCT06859177","Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies","Remote Electrophysiological Cardiotocography (eCTG), Evaluation of Feasibility in (a Selected Group of) Complicated Pregnancies From 32 Until 37 Weeks Gestational Age in a Home@Hospital Setting: a Prospective Cohort Study","HASTA","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Minimum age of 18 years old\n* Pregnant patients with a gestational age between 32+0 and 36+6 weeks and days\n* Singleton pregnancy\n* Any indication for fetal monitoring at least twice per week (e.g.):\n\n  * Pre-eclampsia (PE)\n  * Fetal growth restriction (FGR)\n  * Preterm pre-labor rupture of membranes (PPROM)\n* Absence of exclusion criteria \\> 24 hours after admission.\n* Oral and written informed consent is obtained.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* An indication for intravenous medication\n* Blood pressure \\>160\u002F110 A millimeter of mercury (mmHg)\n* Absent-\u002For reversed flow umbilical artery Doppler\n* Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) (Table 1)\n* Obstetric intervention expected \\\u003C48 hours, e.g. due to:\n\n  * Non reassuring cardiotocography (CTG)\n  * Active vaginal blood loss\n  * Signs of abruption placentae\n  * Meconium stained amniotic fluid\n  * Signs of chorioamnionitis\n* Patients admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).\n* Insufficient knowledge of Dutch or English language\n* Insufficient comprehension of instruction Nemo Remote® or patient information\n* Fetal and\u002For maternal cardiac arrhythmias\n* Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)\n* Patients connected to an external or implanted electrical stimulator, such as Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance of the electrophysiological signal).",true,"FEMALE","18 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","The objective of this single center, interventional cohort study is to evaluate the feasibility of remote electrophysiological cardiotocography (eCTG) monitoring in complicated pregnancies in a home@hospital setting.\n\nThe primary objective is to assess:\n\n• The success rate of the self-administered eCTG measurement\n\nThe secondary objective is to asses:\n\n* Maternal and perinatal outcomes\n* Patients wellbeing and satisfaction.\n* Healthcare professionals' (HCPs') satisfaction\n* Analysis of antenatal costs\n\nParticipants will:\n\n* Self-administer remote eCTG monitoring once daily during admission (or at least twice weekly at the outpatient clinic)\n* Self-measure their blood pressure, heartrate and temperature\n* Enter the measurements, symptoms and worries into an application on their telephone.\n* Answer questionnaires at 3 moments during the study, assessing their wellbeing and satisfaction of the received care and self-administered remote monitoring device.",[89,90,91],"Pregnancy Related","Remote Monitoring","Feasibility",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"feasibility","remote","complicated pregnancies","antenatal","Non invasive fetal electrocardiography (NI-fECG)","electrophysiological cardiotocography (eCTG)","high-risk pregnancies","pregnancy","maternal and fetal monitoring","monitoring","electrophysiological","non invasive","preterm pre-labor rupture of membranes (PPROM)","pre-eclampsia (PE)","fetal growth restriction (FGR)","home monitoring","remote monitoring","second trimester","self-administered","satisfaction","2025-09-23",{"date":115,"type":116},"2025-09-26","ACTUAL",{"date":118,"type":116},"2025-03-25",{"date":120,"type":83},"2026-12",{"name":5,"class":6},1]