Clinical trial NCT06822439: Remote Fetal Monitoring in High Risk Pregnancies
Official title: Investigating the Acceptability and Feasibility of Remote Fetal Monitoring in a High Risk Obstetric Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High Risk Pregnancy
Remote Patient Monitoring
Diabetes
Hypertension
Keywords: Pregnancy
Non invasive testing
Remote patient monitoring
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Biorithm Pte Ltd
First posted: 2025-02-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High risk pregnancies that are recommend to undergo at least once weekly in-office antenatal testing.

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.

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

Primary outcomes:
measure: Percent of sessions completed
timeFrame: 6 weeks
measure: Percentage of interpretable sessions
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: