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Remote Fetal Monitoring in High Risk Pregnancies
NCT06822439 · Beth Israel Deaconess Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Investigating the Acceptability and Feasibility of Remote Fetal Monitoring in a High Risk Obstetric Population
About this study
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.
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
Study design
Enrollment target: 50 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-05-01
Estimated completion: 2027-01-01
Last updated: 2026-03-09
Interventions
Device: Fetal ECG monitoring
Primary outcomes
- • Percent of sessions completed (6 weeks)
- • Percentage of interpretable sessions (6 weeks)
Sponsor
Beth Israel Deaconess Medical Center · other
With: Biorithm Pte Ltd
Contacts & investigators
ContactEthan Litman, MD, MS · contact · elitman@bidmc.harvard.edu · 617-677-3000
ContactChloe Zera, MD, MPH · contact · czera@bidmc.harvard.edu · 617-667-3000
All locations (1)
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States