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

2026年9月11日 更新者：Kenneth Moise MD

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Texas
      • Austin、Texas、美国、78723
      • Galveston、Texas、美国、77555
        • 招聘中
        • University of Texas Medical Branch at Galveston - UTMB Health
        • 接触：
        • 接触：
        • 副研究员：
          • Corey C. Clifford, DO
      • Houston、Texas、美国、77030
        • 招聘中
        • McGovern Medical School - UTHealth Houston
        • 接触：
        • 接触：
        • 副研究员：
          • Jerrie S. Refuerzo, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

Pregnant women between 28 - 40 weeks of gestation with a singleton pregnancy.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Single Group Assignment
Pregnant women between 28 - 40 weeks gestation will record sounds coming from their pregnant abdomen daily for 15 minutes with the Womb Watch smartphone application. Participants must have a singleton intrauterine pregnancy, diagnosed as a low-risk or high-risk pregnancy, no prior diagnosis of an anxiety mood disorder or a psychiatric illness, access to the internet, a functioning email address, owns a personal smartphone, and be English speaking.
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility of Fetal Movement Assessment Using Pilot Womb Watch Smartphone Application
大体时间：From July 2026 to September 2027

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.
From July 2026 to September 2027

次要结果测量

结果测量
措施说明
大体时间
Fetal Gross Movement Assessment
大体时间：From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. Kick counts and gross motor movements will be assessed daily.
The app is designed to collect audio of the fetus moving. Kicks/gross motor movements will be counted.
From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. Kick counts and gross motor movements will be assessed daily.
Fetal Breathing
大体时间：From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. Kick counts and gross motor movements will be assessed daily.
The app is designed to collect audio of the fetal breathing. Fetal breathing duration will be counted in minutes.
From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. Kick counts and gross motor movements will be assessed daily.
Fetal Hiccups
大体时间：From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. Fetal hiccups will be assessed daily.
The app is designed to collect audio of the fetal hiccups. Fetal hiccups will be counted in minutes.
From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. Fetal hiccups will be assessed daily.
Fetal Movement Intensity
大体时间：From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. The Likert scale coincide with daily recordings made by the participant.
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.
From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. The Likert scale coincide with daily recordings made by the participant.
Amniotic Fluid Index
大体时间：From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. AFI will be assessed only after a participant has an ultrasound as part of their routine pregnancy care.
Participant ultrasound records will be reviewed for the duration of their study timeline. We will record their amniotic fluid index (AFI). We believe this may affect the audio quality of fetal movement assessment.
From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. AFI will be assessed only after a participant has an ultrasound as part of their routine pregnancy care.
Generalized Anxiety Disorder Screening (GAD-7)
大体时间：Once at enrollment (28-32 weeks gestation), once every four weeks from the time of enrollment, and one after delivery.
Participants will complete GAD-7 surveys at the time of enrollment, once every 4 weeks throughout pregnancy and one final GAD-7 survey after delivery. This is to ensure that the app is not creating anxiety in participants. If a participant scores 10+ on any of the GAD-7 surveys, they may be withdrawn from the study and referred for appropriate follow up.
Once at enrollment (28-32 weeks gestation), once every four weeks from the time of enrollment, and one after delivery.
Haptic data
大体时间：From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. Haptic data will be assessed daily.
Sensors within the smartphone will be included to capture haptic data using the gyroscope and ambient light sensor. This is to record intensity of fetal movements as well as user behaviors.
From the time of enrollment at 28 to 32 weeks' gestation, up until delivery. Haptic data will be assessed daily.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kenneth Moise MD

合作者

The University of Texas Health Science Center, Houston
The University of Texas Medical Branch, Galveston

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月6日

初级完成 (估计的)

2027年9月30日

研究完成 (估计的)

2027年9月30日

研究注册日期

首次提交

2026年5月23日

首先提交符合 QC 标准的

2026年5月30日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00009098
  • FP00014631 (其他标识符：UT REAL Health AI Pilot Program)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The data generated from this feasibility trial will be used to further refine the AI model to detect fetall movements

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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