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.
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
Currently pregnant with multiples (twins or more)
Baseline GAD-7 score of 10 or more
Pregnant women between 28 - 40 weeks of gestation with a singleton pregnancy.
Other
Prospective
Smartphone Application
DevicePregnant 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.
Feasibility of Fetal Movement Assessment Using Pilot Womb Watch Smartphone Application
Audio signals from different models and brands of smartphones with or without smartphone cases will be compared in our AI model. Participants using the pilot Womb Watch smartphone application will receive feedback on fetal movement assessment and help researchers determine if the application needs to be modified for real-world use.
Fetal Gross Movement Assessment
The app is designed to collect audio of the fetus moving. Kicks/gross motor movements will be counted.
Fetal Breathing
The app is designed to collect audio of the fetal breathing. Fetal breathing duration will be counted in minutes.
Fetal Hiccups
The app is designed to collect audio of the fetal hiccups. Fetal hiccups will be counted in minutes.
Fetal Movement Intensity
After completing a recording within the app, participants will be asked to rank the intensity of the fetal movements they felt during that recording using a Likert scale within the app. A zero would indicate they didn't feel baby move at all or movements felt weak/faint, whereas a 10 would indicate the baby had very strong movements.
Click on the lead sponsor to view all of their trials.
Kenneth Moise MD
Lead sponsor
University of Texas at Austin
Sponsor institution
The University of Texas Health Science Center, Houston
Collaborator
The University of Texas Medical Branch, Galveston
Collaborator
