An interventional study of wearable ultrasound patch in Pregnancy - Labor Monitoring, Labor and Childbirth and Fetal Heart Rate Tracing, sponsored by Stanford University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Stanford University · Not applicable, Interventional, and Device feasibility
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.
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/fetal 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.
Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
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Exclusion Criteria:
A wearable ultrasound patch will be externally applied to intact maternal abdominal skin using ultrasound coupling material and/or 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.
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.
Feasibility of ultrasound imaging of uterus, fetal heart and fetoplacental blood vessels
Ability to acquire dynamic imaging of the uterus, fetal heart and fetal/placental blood vessels with a wearable ultrasound patch during parturition.
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Adherence
Proportion of participants completing continuous device wear for the intended monitoring period.
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Need for repositioning
Number of device repositioning events per participant during the monitoring period to obtain accurate imaging
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
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.
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
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.
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Movement effects
Qualitative effect of maternal and fetal movement on imaging acquisition
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Placental location effect
Qualitative effect of placental location on successful imaging acquisition
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Participant satisfaction
Participant satisfaction with wearing the ultrasound patch using a 0-10 NRS
Time frame: At device-wear completion, defined as participant- or study team-initiated device removal or completion of the third stage of labor, whichever occurs first.
Adverse effects
Adverse effects determined to be device-related, such as maternal discomfort, skin irritation, or interference with standard care
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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