About this trial

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 criteria

Qualifiers

Intrauterine pregnancy greater than 32 weeks gestation

Recommended for at least once weekly antenatal fetal testing by their obstetrician

English-speaking

Disqualifiers

Under age 18 years of old

Non-english speaking

Trial design

Treatments tested in this trial

  • Fetal ECG monitoring

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

1
Beth Israel Deaconess Medical Center02115, BostonMassachusetts, United States

Sponsors and collaborators

Beth Israel Deaconess Medical Center

Lead sponsor

Biorithm Pte Ltd

Collaborator