Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements (NCT07626112) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements
United States60 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying a smartphone app called Womb Watch to track fetal movements — given that it's a feasibility study just testing whether the app can work, not whether it actually prevents stillbirth, is it something worth me participating in at this stage of the research?
2Since this trial hasn't started recruiting yet, do you know when it's expected to open, and would it make sense for me to wait for it or focus on other options in the meantime?
3The trial is focused on fetal movement monitoring, which is connected to stillbirth risk — based on my specific pregnancy, do you think more structured fetal movement tracking is something I should be doing regardless of whether I join this study?
4Because this is a feasibility trial rather than a full clinical trial, it's primarily testing whether the app is usable and practical — what would that mean for me in terms of what I'd actually be asked to do, and would I get any direct medical benefit from participating?
5Are there already established methods or tools for monitoring fetal movements that you'd recommend for me now, while this app trial is still in early development?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Fetal Movement Assessment Using Pilot Womb Watch Smartphone Application