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RECRUITING
NCT06822439

Remote Fetal Monitoring in High Risk Pregnancies

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2025-05-01

Completion Date

2027-01-01

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DEVICE

Fetal 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