Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Location contact
Chloe Zera, MD, MPH
PRINCIPAL_INVESTIGATOR
Ethan Litman, MD,MS
CONTACT
Ethan Litman, MD,MS
SUB_INVESTIGATOR
Recruiting
NCT Number: NCT06822439
Remote Fetal Monitoring in High Risk Pregnancies
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Fetal ECG monitoring
DevicePatients will wear a fetal ECG monitor which they will place on their abdomen
Primary outcomes
-
Percent of sessions completed
Time frame: 6 weeks
Percentage of completed remote monitoring sessions
-
Percentage of interpretable sessions
Time frame: 6 weeks
Percentage of interpretable monitoring sesions
Secondary outcomes
-
Patient satisfaction
Time frame: 6 weeks
Patient satisfaction with device using a Likert rating scale (range 1 - 5)
Study contacts
Contact information is provided by the study sponsor or research team.
Chloe Zera, MD, MPH
CONTACT
Ethan Litman, MD, MS
CONTACT
Sponsors and collaborators
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Collaborators
- Biorithm Pte Ltd
Registry information
Official study title
Investigating the Acceptability and Feasibility of Remote Fetal Monitoring in a High Risk Obstetric Population
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Feb 12, 2025
- Registry last updated
- Mar 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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