NCT07626112 Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements
| NCT ID | NCT07626112 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kenneth Moise MD |
| Condition | Assessment of Fetal Movement |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-06 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-08-06 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The surveillance of pregnancies at risk for fetal loss secondary to high-risk maternal or fetal conditions remains a mainstay of perinatal care. Current testing to prevent fetal loss includes the regular use of ultrasound (biophysical profile) or fetal heart rate monitoring (non-stress test) in an outpatient clinic setting once or twice weekly. A patient may also be asked to subjectively assess daily fetal movements during the time between routine antepartum testing appointments. However, there are no good systems for pregnant women to objectively measure fetal movements. Smartphones have allowed for the development of applications that utilize various embedded devices including the camera and microphone. In our recent pilot STUDY00001552 of 205 pregnant patients, placement of the iPhone10 microphone directly on the maternal abdominal wall was utilized to detect fetal movements. AI assessment of the audio recordings proved superior to maternal perception of fetal movements that were recorded during simultaneous ultrasound (gross fetal movements: 64% audio vs 18% maternal; breathing: 93% vs 3%, hiccups: 73% vs 3%). This trial is a prospective, observational, feasibility study of 60 patients that includes both low-risk and high-risk pregnant women to examine the usability of the Womb Watch smartphone application. The study will involve introduction of the Womb Watch app to a population of pregnant patients. Features of the app will be modified based on participant feedback. Anxiety levels of the patient will be tracked serially using a survey tool. The various types and versions of smartphones will be assessed to see if they affect the AI model. Finally, patients will be asked to determine the strength of fetal movements to see if this parameter can be assessed by the AI model. Amniotic fluid data will assessed through clinical ultrasounds to see if this also has any effect on the AI model's ability to detect fetal movements.
Eligibility Criteria
Inclusion Criteria: * Ability to understand and voluntarily provide written signed informed consent to participate in the study. * English speaking (the alpha version of the Womb Watch app is only available in English) * Singleton intrauterine pregnancy * Estimated gestational age at enrollment 28 weeks to 32 weeks * Low-risk pregnancy with normal fetal growth and anatomy and no maternal co-morbidities of note. * High-risk pregnancy including fetal anomalies and maternal co-morbidities including but not limited to cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine/metabolic, immunologic, dermatologic, neurologic, or oncologic. * No prior diagnosis of an anxiety mood disorder or a psychiatric illness * Access to internet * A functioning email address * Owns personal smartphone; iPhone or Android of any generation Exclusion Criteria: * Currently pregnant with multiples (twins or more) * Baseline GAD-7 score of 10 or more
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07626112 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Assessment of Fetal Movement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07626112 currently recruiting?
Yes, NCT07626112 is actively recruiting participants. Contact the research team at kmoise@austin.utexas.edu for enrollment information.
Where is the NCT07626112 trial being conducted?
This trial is being conducted at Austin, United States, Galveston, United States, Houston, United States.
Who is sponsoring the NCT07626112 clinical trial?
NCT07626112 is sponsored by Kenneth Moise MD. The trial plans to enroll 60 participants.