[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598870":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":31,"collaborators":19,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":42,"sex":43,"minAge":44,"maxAge":19,"enrollmentInfo":45,"targetDuration":19,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":59,"whyStopped":19,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":19},{"fullName":5,"class":6},"Maxima Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Electrophysiological monitoring","EXPERIMENTAL","See intervention",[13],"Device: Electrophysiological monitoring",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","electrofysiological CTG monitoring with the Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands). The NFMS consists of a wireless and beltless electrode patch on the maternal abdomen. It monitors fetal heart rate by fetal electrocardiography, maternal heart rate by maternal electrocardiography and the electrical activity of the uterine muscle by electrohysterography.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Simone Goossens, PhD","Principal Investigator","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Phebe Berben, Medical Doctor, PhD Candidate","CONTACT","+3140 - 888 80","phebe.berben@mmc.nl",{"type":24,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Phebe Berben","Medical doctor, PhD Candidate, Coordinating Investigator NIEM-S study","100598870","feasibility-study-continuous-fetal-monitoring-during-maternal-exercise-100598870",false,"NCT07077109","Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise","Continuous Non-invasive Electrophysiological Monitoring During Maternal Exercise: a Feasibility Study","NIEM-S","Inclusion Criteria:\n\n* Minimal age of 18 years old\n* Pregnant women with an uncomplicated singleton pregnancy and a gestational age between 30+0 and 40+0 weeks and days\n* Oral and written informed consent is obtained\n* Engage in aerobic exercise during pregnancy\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Insufficient knowledge of Dutch or English language\n* Women with a multiple pregnancy\n* Contra-indications for the Nemo Fetal Monitoring System (NFMS):\n\n  * Fetal and\u002For maternal cardiac arrhythmias\n  * Contraindications to abdominal placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)\n  * Women connected to an external or implanted electrical stimulator, such as a pacemaker (because of disturbance of the electrophysiological signal)\n* Fetus with known congenital or chromosomal abnormalities\n* Women with absolute or relative contraindications to aerobic exercise during pregnancy at time of inclusions and during maternal exercise:\n\n  * Mild or severe respiratory diseases (e.g. chronic obstructive pulmonary disease, restrictive lung disease and cystic fibrosis)\n  * Mild or severe acquired or congenital heart disease with exercise intolerance\n  * Uncontrolled or severe arrhythmia\n  * Vasa previa\n  * Type 1 diabetes\n  * IUGR\n  * Severe PE\n  * Cervical insufficiency\n* Women with relative contraindications to aerobic exercise during pregnancy:\n\n  * Mild respiratory disorders\n  * Mild congenital or acquired heart disease\n  * Well-controlled type 1 diabetes\n  * Pre-eclampsia\n  * Cervical insufficiency\n  * Placenta previa\n  * Untreated thyroid disease\n  * Symptomatic, severe eating disorder\n  * Multiple nutrient deficiencies and\u002For chronic undernutrition\n  * Moderate-heavy smoking (\\> 20 cigarettes per day)",true,"FEMALE","18 Years",{"count":46,"type":47},15,"ESTIMATED","INTERVENTIONAL",[50],"NA","This feasibility study will be the first study to assess the feasibility of continuous electrophysiological monitoring during maternal exercise in women with an uncomplicated pregnancy. This may help to better understand fetal condition during exercise and offer personalised exercise recommendations in the future. In future, validating the feasibility and safety of exercise could promote greater exercise engagement among pregnant women and increase fetal wellbeiing.",[53,54],"Pregnancy","Monitoring",[9,53,56,57,58],"Sport","Feasibility study","Maternal exercise","NOT_YET_RECRUITING","2025-07-23",{"date":62,"type":63},"2025-07-28","ACTUAL",{"date":65,"type":47},"2025-10-15",{"date":67,"type":47},"2026-03-13",{"name":5,"class":6}]