Remote Fetal Monitoring in High Risk Pregnancies

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Diabetes; High Risk Pregnancy; Remote Patient Monitoring
• Intervention / Treatment: Device: Fetal ECG monitoring

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ethan Litman, MD, MS; Phone Number: 617-677-3000; Email: elitman@bidmc.harvard.edu
• Study Contact Backup: Name: Chloe Zera, MD, MPH; Phone Number: 617-667-3000; Email: czera@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Ethan Litman, MD,MS; Phone Number: 617-667-3000; Email: elitman@bidmc.harvard.edu
      • Principal Investigator: Chloe Zera, MD, MPH
      • Sub-Investigator: Ethan Litman, MD,MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

High risk pregnancies that are recommend to undergo at least once weekly in-office antenatal testing.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remote Monitoring; A cohort of patients with high risk pregnancies who will wear a remote monitoring device	Device: Fetal ECG monitoring; Patients will wear a fetal ECG monitor which they will place on their abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of sessions completed	Percentage of completed remote monitoring sessions	6 weeks
Percentage of interpretable sessions	Percentage of interpretable monitoring sesions	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction with device using a Likert rating scale (range 1 - 5)	6 weeks

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Biorithm Pte Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Remote patient monitoring; Non invasive testing
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus
• Other Study ID Numbers: 2024P000011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study assessing the feasibility of using a novel device. We do not plan to share survey data from participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No