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

Inclusion Criteria3

  • Intrauterine pregnancy greater than 32 weeks gestation
  • Recommended for at least once weekly antenatal fetal testing by their obstetrician
  • English-speaking

Exclusion Criteria2

  • Under age 18 years of old
  • Non-english speaking

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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