RecruitingNCT06822439

Remote Fetal Monitoring in High Risk Pregnancies

Investigating the Acceptability and Feasibility of Remote Fetal Monitoring in a High Risk Obstetric Population


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

50 participants

Start Date

May 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Antenatal nonstress tests (NSTs) are performed to assess fetal health and are used as a cost-effective test that can be widely administered. However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting. The ability to conduct a clinically valuable test at home would address access to care issues faced by numerous women in the United States and reduce the workload on healthcare clinicians facing a shortage of human resources. This pilot study aims to assess the feasibility and acceptability of home NST monitoring in order to determine whether femomTM could be utilized as an adjunct to routine prenatal care. Patients with high risk pregnancies who are recommended to undergo at least once weekly at 32 weeks testing by the obstetrician will be recruited for participation in this study. Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether at-home fetal monitoring (using a wearable device) is as safe and accurate as in-clinic monitoring for pregnant women with high-risk pregnancies who require regular checks on their baby's wellbeing. **You may be eligible if...** - You are more than 32 weeks pregnant - Your obstetrician has recommended at least weekly fetal monitoring (antenatal testing) - You speak English **You may NOT be eligible if...** - You are under 18 years old - You do not speak English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFetal ECG monitoring

Patients will wear a fetal ECG monitor which they will place on their abdomen


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT06822439


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