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Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements
Sponsor: Kenneth Moise MD
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.
Official title: A Pilot Study of the Womb Watch App: Fetal Assessment Using the Microphone of the Smartphone
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-08-06
Completion Date
2027-09-30
Last Updated
2026-09-02
Healthy Volunteers
No
Conditions
Interventions
Smartphone Application
Pregnant women between 28 - 40 weeks gestation will audio daily for 15 minutes using their personal smartphone with upload to the Womb Watch app. The microphone of the smartphone will be placed against the pregnant uterus. The audio files will be uploaded from the Womb Watch app via Google Firestore to an encrypted database at the Texas Advanced Computing Center (TACC-UT Austin). After the audio recording is uploaded, participants will be asked to assess the strength of fetal movements using a Likert scale in the app. Artificial intelligence will be employed to determine the number and strength of three categories of fetal movements: gross body movements, fetal breathing and fetal hiccups. Participants will receive the AI analysis regarding these movements through the customized app.
Locations (3)
Dell Medical School- University of Texas at Austin
Austin, Texas, United States
University of Texas Medical Branch at Galveston - UTMB Health
Galveston, Texas, United States
McGovern Medical School - UTHealth Houston
Houston, Texas, United States