NCT06822439 Remote Fetal Monitoring in High Risk Pregnancies
| NCT ID | NCT06822439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | High Risk Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-05-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Intrauterine pregnancy greater than 32 weeks gestation * Recommended for at least once weekly antenatal fetal testing by their obstetrician * English-speaking Exclusion Criteria: * Under age 18 years of old * Non-english speaking
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06822439 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying High Risk Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06822439 currently recruiting?
Yes, NCT06822439 is actively recruiting participants. Contact the research team at elitman@bidmc.harvard.edu for enrollment information.
Where is the NCT06822439 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06822439 clinical trial?
NCT06822439 is sponsored by Beth Israel Deaconess Medical Center. The trial plans to enroll 50 participants.