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

A Pilot Study of the Womb Watch App: Fetal Assessment Using the Microphone of the Smartphone

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.

60 pregnant participants in total (mixed population of low-risk and high-risk pregnancies) will be approached at 28-32 weeks' gestation to participate in the study. 20 patients will be enrolled at each of three health science centers - Dell Medical School - UT Austin, UT Health in Houston and UTMB Health in Galveston. Participant's will be identified through medical record review or by self interest through a recruitment flyer. Signed written informed consent will be obtained in-person by a study coordinator (SC) on an Apple iPad within the HIPAA-compliant UT Austin REDCap database. Participants will be assigned their participant ID in REDCap and then complete a baseline Generalized Anxiety Disorder survey (GAD-7) to ensure eligibility. A score of 10 or more is an exclusion criteria. If they qualify to participate, they will then be asked to download the prototype Womb Watch application to their personal smartphone. iPhones and Androids of any generation may be used. Participants must own a personal smartphone with access to an internet connection to qualify for the study.

When a participant opens the application for the first time they will be provided with various options for setting up the app. These include written instructions and/or an animated instructional video. A study coordinator will assist with the initial setting up of the app. The ID that was assigned to the participant in the REDCap database will match the ID assigned in the Womb Watch app. Participants can choose their own username and password for the app. Additionally, the app requires that the participant provides a current email address, which the participant must confirm. When a participant registers on the app, they are asked for a phone number for a one -time, two-factor authentication. The following participant data will be stored encrypted on the Texas Advanced Computing Center (TACC; Austin, Texas) Firestore database: email address, phone number, Participant ID, audio recordings, and Likert Scale assessment of fetal movement strength. Participant data that will be stored in the HIPAA-compliant, encrypted UT Austin REDCap database and will include demographics, usability statistics, GAD-7 surveys, and clinical outcomes of pregnancies.

All participants will utilize the Womb Watch smartphone application from enrollment until delivery. Participants will be asked to use Womb Watch for 15 minutes daily, preferably in the evening at a time of their choosing. Participants will be informed during consent that the smartphone will record more than just the fetal movement sounds, and as such they should record in a quiet space with minimal conversations. In addition to the intended recording of sounds produced by fetal movement, the app will record all audible sounds. Participants will be informed that audio files which are transmitted to TACC for analysis will be deidentified and the sounds recorded will not be traceable back to them-only the frequency of sound associated with fetal movement sounds will be analyzed. In situations where an audio recording is complicated by noise disruptions in the environment, participants will have the option to delete the recording and re-record a new audio file. The app is designed such that no more than one audio file will be on their phone at a given time.

Study coordinators will contact participants by phone every two weeks to check in to ensure the app is functioning correctly and to answer any participant questions. All app usage and audio recordings will be maintained within the REDCap database. If a participant fails to use the app for 3 consecutive days, the participants and coordinator will receive an automated reminder from the REDCap database via email prompting them to record another fetal movement assessment. If a participant fails to use the app for another 3 consecutive days, the participant and coordinator will receive a second automated email reminder to record using the app. If a participant fails to use the app for 7 consecutive days, the coordinator will be notified via email from the REDCap database. SCs will then contact the participants by phone to determine if they are still interested in participating and/or determine if they are still pregnant. If a participant is unable to be reached after 3 automated reminders are sent, they will be considered lost to follow up and removed from the study.

Participants will be asked to complete up to four GAD-7 surveys-one at the time of enrollment, and again every 4 weeks while using the app. The number of surveys will vary by participant, depending on their gestation at enrollment. Participants will be sent a link to the surveys via text message or to their personal email. Survey responses will be recorded automatically in the database. If the participant's GAD-7 scores are elevated (scoring 10+) they will be flagged for behavioral health follow-up, referred to clinical care, or removed from the study if clinically appropriate at the discretion of the PI or Co-I. Once a participant delivers, they will be asked to complete a final GAD-7 survey and a Usability survey within 7 days. Participants will then be asked to remove the app from their personal device.

This is a Multi-Site Study that involves more than one site performing all aspects of the research procedures as outlined above.

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