Wearable Ultrasound Patch in Parturients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
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
receiving obstetric care at a Stanford-affiliated facility
able to understand the study procedures and provide informed consent
Disqualifiers
age younger than 18 years
gestational age less than 20 weeks for pregnant participants, or delivery before 20 weeks for postpartum participants.
inability to provide informed consent.
maternal or fetal clinical instability for which the treating obstetric team determines that research participation would be inappropriate.
Trial design
Design model
Single group
Treatments tested in this trial
wearable ultrasound patch
DeviceThe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Wearable Ultrasound PatchExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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