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Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements

Recruitingn/aAges 18 Years - 45 YearsFemaleKenneth Moise MD
NCT07626112 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 asse

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📋 Eligibility rules (as published)
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
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What it tests

  • Smartphone Application
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Where

3 sites
Dell Medical School- University of Texas at Austin
Austin, United States
University of Texas Medical Branch at Galveston - UTMB Health
Galveston, United States
McGovern Medical School - UTHealth Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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