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Remote Fetal Monitoring in High Risk Pregnancies

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06822439
Enrollment
50
Registered
2025-02-12
Start date
2025-05-01
Completion date
2027-01-01
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, High Risk Pregnancy, Hypertension, Remote Patient Monitoring

Keywords

Pregnancy, Non invasive testing, Remote patient monitoring

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.

Detailed description

Measuring fetal heart rate (FHR) through various methods is essential for assessing fetal wellbeing antenatally. This enables clinicians to identify patterns that could indicate fetal hypoxia. Cardiotocography (CTG), which uses Doppler ultrasound, is the gold standard for non-invasive FHR monitoring. This technology detects movement in the cardiac structures and approximates the FHR from this and requires signal modulation and auto-correlation to provide accurate quality readings of FHR. This method of external FHR monitoring is prone to signal loss, maternal fetal ambiguity where the maternal heart rate is confused for FHR, and signal artefacts (e.g., double-counting, and half-counting), during both antenatal and intrapartum monitoring, and must be performed by an obstetric provider. Non-invasive fetal electrocardiography (NIFECG) is a form of electrocardiography (ECG), which captures simultaneous maternal and fetal PQRST waves. NIFECG has the theoretical benefits of minimizing maternal-fetal heart activity confusion, is not affected by maternal adiposity, and delivers no energy to the patient, which permits prolonged periods of fetal monitoring with safety. To date, NIFECG has mostly been limited to research use due to low fetal signal-to-noise ratios. Despite technical challenges, NIFECG may be the most promising method of ambulatory self-applied FHR monitoring.

Interventions

DEVICEFetal ECG monitoring

Patients will wear a fetal ECG monitor which they will place on their abdomen

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER
Biorithm Pte Ltd
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent of sessions completed6 weeksPercentage of completed remote monitoring sessions
Percentage of interpretable sessions6 weeksPercentage of interpretable monitoring sesions

Secondary

MeasureTime frameDescription
Patient satisfaction6 weeksPatient satisfaction with device using a Likert rating scale (range 1 - 5)

Countries

United States

Contacts

CONTACTEthan Litman, MD, MS
elitman@bidmc.harvard.edu617-677-3000
CONTACTChloe Zera, MD, MPH
czera@bidmc.harvard.edu617-667-3000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026