Pregnancy - Labor MonitoringNCT07871903
Wearable Ultrasound Patch in Parturients
A study testing wearable ultrasound patch in people with Pregnancy - Labor Monitoring and Labor and Childbirth, run by Stanford University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy - Labor Monitoring, Labor and Childbirth, Fetal Heart Rate Tracing
- What is being tested?
- wearable ultrasound patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- considered clinically appropriate for participation by the treating obstetric team
- intact maternal abdominal skin at the intended wearable ultrasound patch placement location
- physically able to undergo placement of the wearable ultrasound patch on the maternal abdomen
- have an available acoustic window that permits an attempt at uterine imaging or, during pregnancy, fetal imaging or physiological monitoring
Who cannot join
- 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.
- an obstetric emergency or other clinical condition requiring immediate evaluation, intervention, or uninterrupted clinical monitoring.
- 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.
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- known allergy or significant sensitivity to materials used in the wearable device, adhesive, or coupling interface.
- 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.
- any other circumstance in which the treating clinician determines that participation would not be in the best interest of the participant or fetus.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Continuous Uterine Contraction Monitoring, Fetal Imaging, and Hemodynamic Monitoring With a Wearable Ultrasound Patch
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.
Read the detailed description
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.
- Being tested
- wearable ultrasound patch
- Keywords
- tocometry, fetal heart tracing, labor contraction measurement, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable ultrasound patchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Ultrasound Patch | Experimental | 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. Receives: Device: wearable ultrasound patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Secondary outcomes (7)
Adherence
Proportion of participants completing continuous device wear for the intended monitoring period.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At device-wear completion, defined as participant- or study team-initiated device removal or completion of the third stage of labor, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy - Labor MonitoringStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naida Cole, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871903
- Sponsor's protocol ID
- IRB-89131
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Uterine Contraction Monitoring, Fetal Imaging, and Hemodynamic Monitoring With a Wearable Ultrasound Patch
- ClinicalTrials.gov ID
- NCT07871903
- Acronym / sponsor ID
- IRB-89131
- Keywords
- tocometry, fetal heart tracing, labor contraction measurement, ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable Ultrasound Patch | Experimental | Device: wearable ultrasound patchA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- considered clinically appropriate for participation by the treating obstetric team
Key exclusion criteria (9 listed)
- 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.
- an obstetric emergency or other clinical condition requiring immediate evaluation, intervention, or uninterrupted clinical monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearable ultrasound patchThe 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. | Device | Wearable Ultrasound Patch |
Primary outcome
Feasibility of ultrasound imaging of uterus, fetal heart and fetoplacental blood vessels
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Ability to acquire dynamic imaging of the uterus, fetal heart and fetal/placental blood vessels with a wearable ultrasound patch during parturition.
7 secondary outcomes
Adherence
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Need for repositioning
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Agreement in fetal heart rate measurements
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Agreement in maternal contraction measurements
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Movement effects
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Placental location effect
Time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)
Participant satisfaction
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing wearable ultrasound patch in people with Pregnancy - Labor Monitoring and Labor and Childbirth, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naida Cole, MD (650-723-5439, nmcole@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of ultrasound imaging of uterus, fetal heart and fetoplacental blood vessels (time frame: From enrollment until the end of stage 3 of labor (approximately 2 hours to 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.