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
Sponsors and collaborators
Beth Israel Deaconess Medical Center
Lead sponsor
Biorithm Pte Ltd
Collaborator