Remote Fetal Monitoring in High Risk Pregnancies

NCT ID: NCT06822439

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-01

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.

Conditions

High Risk Pregnancy; Remote Patient Monitoring; Diabetes; Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Remote Monitoring

A cohort of patients with high risk pregnancies who will wear a remote monitoring device

Fetal ECG monitoring

Intervention Type: DEVICE

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

Interventions

Fetal ECG monitoring

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biorithm Pte Ltd

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ethan Litman

Clinical Fellow, Division of Maternal Fetal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ethan Litman, MD, MS

Role: CONTACT

elitman@bidmc.harvard.edu

617-677-3000

Chloe Zera, MD, MPH

Role: CONTACT

czera@bidmc.harvard.edu

617-667-3000

Facility Contacts

Ethan Litman, MD,MS

Role: primary

elitman@bidmc.harvard.edu

617-667-3000

Other Identifiers

2024P000011

Identifier Type: -

Identifier Source: org_study_id