[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659940":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":47,"studyPopulation":43,"armGroups":48,"interventions":55,"overallOfficials":43,"centralContacts":61,"locations":43,"responsibleParty":67,"collaborators":43,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":43,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":43,"enrollmentInfo":80,"targetDuration":43,"studyType":83,"phases":84,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":95,"whyStopped":43,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":43},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility of ultrasound imaging of uterus, fetal heart and fetoplacental blood vessels","Ability to acquire dynamic imaging of the uterus, fetal heart and fetal\u002Fplacental blood vessels with a wearable ultrasound patch during parturition.","From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Adherence","Proportion of participants completing continuous device wear for the intended monitoring period.",{"measure":18,"description":19,"timeFrame":12},"Need for repositioning","Number of device repositioning events per participant during the monitoring period to obtain accurate imaging",{"measure":21,"description":22,"timeFrame":12},"Agreement in fetal heart rate measurements","Paired fetal heart-rate measurements obtained from the wearable ultrasound device and standard external fetal heart-rate monitoring during labor.",{"measure":24,"description":25,"timeFrame":12},"Agreement in maternal contraction measurements","Paired uterine contraction measurements obtained from the wearable patch and standard external tocometry or intrauterine pressure catheter during labor, including agreement in contraction onset time, offset time, and duration.",{"measure":27,"description":28,"timeFrame":12},"Movement effects","Qualitative effect of maternal and fetal movement on imaging acquisition",{"measure":30,"description":31,"timeFrame":12},"Placental location effect","Qualitative effect of placental location on successful imaging acquisition",{"measure":33,"description":34,"timeFrame":35},"Participant satisfaction","Participant satisfaction with wearing the ultrasound patch using a 0-10 NRS","At device-wear completion, defined as participant- or study team-initiated device removal or completion of the third stage of labor, whichever occurs first.",[37],{"measure":38,"description":39,"timeFrame":12},"Adverse effects","Adverse effects determined to be device-related, such as maternal discomfort, skin irritation, or interference with standard care",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":43,"timePerspective":43,"maskingInfo":45},"NA","SINGLE_GROUP",null,"DEVICE_FEASIBILITY",{"masking":46,"maskingDescription":43,"whoMasked":43},"NONE","This study will evaluate an investigational wearable ultrasound patch for non-invasive monitoring of uterine contractions and, during pregnancy, fetal imaging and physiological monitoring. The soft ultrasound patch will be placed on the maternal abdomen to acquire ultrasound images of the uterine wall and the fetus, and measure maternal\u002Ffetal physiological parameters, including the frequency and duration of uterine contractions, exploratory image-derived measures related to contraction strength, fetal heart rate, and selected fetal anatomical measurements. When technically feasible, the device will also obtain blood-flow information from selected fetal or fetoplacental blood vessels; postpartum measurements will be limited to maternal uterine activity. Measurements may be compared with standard external tocometry, fetal monitoring, and conventional obstetric ultrasound, but the investigational device will not be used for clinical decision-making.",[49],{"label":50,"type":51,"description":52,"interventionNames":53},"Wearable Ultrasound Patch","EXPERIMENTAL","A wearable ultrasound patch will be externally applied to intact maternal abdominal skin using ultrasound coupling material and\u002For a skin-compatible adhesive interface. The patch will acquire serial ultrasound images of the uterine wall. Image-based tracking of uterine-wall displacement and deformation over time will be used to identify contraction-related changes and derive contraction timing, frequency, and duration. The wearable ultrasound patch will also be used to acquire ultrasound images of fetal anatomical structures and record fetal blood flow and cardiac activity.",[54],"Device: wearable ultrasound patch",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":43},"DEVICE","wearable ultrasound patch","The wearable ultrasound patch will be placed on maternal abdominal skin and selected based on the uterine target, fetal position and the anatomical or physiological target of interest. The device may be repositioned if maternal movement, uterine changes, or fetal movement or position causes loss of the target.",[50],[62],{"name":63,"role":64,"phone":65,"phoneExt":43,"email":66},"Naida Cole, MD","CONTACT","650-723-5439","nmcole@stanford.edu",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Naida Cole","Clinical Assistan Professor of Anesthesiology, Perioperative & Pain Medicine","100659940","wearable-ultrasound-patch-in-parturients-100659940",false,"NCT07871903","Wearable Ultrasound Patch in Parturients","Continuous Uterine Contraction Monitoring, Fetal Imaging, and Hemodynamic Monitoring With a Wearable Ultrasound Patch","Inclusion Criteria:\n\n* 18 years of age or older\n* intrauterine pregnancy of 20 weeks of gestation or greater, or postpartum during the same delivery admission following delivery at 20 weeks of gestation or greater\n* receiving obstetric care at a Stanford-affiliated facility\n* able to understand the study procedures and provide informed consent\n* considered clinically appropriate for participation by the treating obstetric team\n* intact maternal abdominal skin at the intended wearable ultrasound patch placement location\n* physically able to undergo placement of the wearable ultrasound patch on the maternal abdomen\n* have an available acoustic window that permits an attempt at uterine imaging or, during pregnancy, fetal imaging or physiological monitoring\n\nExclusion Criteria:\n\n* age younger than 18 years\n* gestational age less than 20 weeks for pregnant participants, or delivery before 20 weeks for postpartum participants.\n* inability to provide informed consent.\n* maternal or fetal clinical instability for which the treating obstetric team determines that research participation would be inappropriate.\n* an obstetric emergency or other clinical condition requiring immediate evaluation, intervention, or uninterrupted clinical monitoring.\n* compromised maternal abdominal skin integrity at the proposed device placement site, including open wounds, active infection, significant rash, burns, or other conditions that would prevent safe placement of the device.\n* known allergy or significant sensitivity to materials used in the wearable device, adhesive, or coupling interface.\n* any condition in which placement or operation of the investigational device could interfere with standard obstetric monitoring, examination, treatment, or access to the maternal abdomen.\n* any other circumstance in which the treating clinician determines that participation would not be in the best interest of the participant or fetus.","FEMALE","18 Years",{"count":81,"type":82},40,"ESTIMATED","INTERVENTIONAL",[41],"This study will assess an investigational ultrasound patch placed on the maternal abdomen to noninvasively monitor uterine activity, obtain fetal images and physiologic measurements in labor. Through this study, the investigators hope to determine the feasibility, signal quality, and measurement accuracy of wearable ultrasound for monitoring uterine activity and fetal wellbeing in the peripartum setting. The knowledge gained may support development of future wearable ultrasound systems capable of providing hands-free, longitudinal, quantitative and non-invasive information about uterine contraction patterns, as well as fetal anatomy, cardiac activity and circulation, thereby complementing existing intrapartum monitoring technologies.",[87,88,89],"Pregnancy - Labor Monitoring","Labor and Childbirth","Fetal Heart Rate Tracing",[91,92,93,94],"tocometry","fetal heart tracing","labor contraction measurement","ultrasound","NOT_YET_RECRUITING","2026-10-06",{"date":98,"type":99},"2026-10-13","ACTUAL",{"date":101,"type":82},"2026-11",{"date":103,"type":82},"2027-11",{"name":5,"class":6}]