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Recruiting No phase listed Observational

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

ClinicalTrials.gov ID: NCT07626112

Public ClinicalTrials.gov record NCT07626112. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 2:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07626112
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Kenneth Moise MD
Other
Enrollment
60 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 5, 2026
Primary completion
Sep 29, 2027
Completion
Sep 29, 2027
Last update posted
Sep 1, 2026

2026 – 2027

United States locations

U.S. sites
3
U.S. states
1
U.S. cities
3
Facility City State ZIP Site status
Dell Medical School- University of Texas at Austin Austin Texas 78723 Not yet recruiting
University of Texas Medical Branch at Galveston - UTMB Health Galveston Texas 77555 Recruiting
McGovern Medical School - UTHealth Houston Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07626112, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 1, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07626112 live on ClinicalTrials.gov.

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