Remote Fetal Monitoring in High Risk Pregnancies

NCT06822439 | Recruiting

• 1 other identifier: 2024P000011
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

High Risk Pregnancy; Remote Patient Monitoring; Diabetes; Hypertension

Keywords

Pregnancy; Non invasive testing; Remote patient monitoring

Outcome Measures

Primary Outcomes (2)

• Percent of sessions completed

  Percentage of completed remote monitoring sessions

  6 weeks

• Percentage of interpretable sessions

  Percentage of interpretable monitoring sesions

  6 weeks

Secondary Outcomes (1)

• Patient satisfaction

  6 weeks

Study Arms (1)

Remote Monitoring

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

Device: Fetal ECG monitoring

Interventions

Fetal ECG monitoring DEVICE

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

Remote Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Intrauterine pregnancy greater than 32 weeks gestation
• Recommended for at least once weekly antenatal fetal testing by their obstetrician
• English-speaking

You may not qualify if:

• Under age 18 years of old
• Non-english speaking

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Biorithm Pte Ltd: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ethan Litman, MD, MS

CONTACT

617-677-3000; elitman@bidmc.harvard.edu

Chloe Zera, MD, MPH

CONTACT

617-667-3000; czera@bidmc.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow, Division of Maternal Fetal Medicine

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 12, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)