Remote Fetal Monitoring in High Risk Pregnancies

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06822439
Status
Recruiting
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Conditions

  • Diabetes
  • High Risk Pregnancy
  • Hypertension
  • Remote Patient Monitoring

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fetal ECG monitoring — DEVICE
    Patients will wear a fetal ECG monitor which they will place on their abdomen

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Remote Monitoring
    A cohort of patients with high risk pregnancies who will wear a remote monitoring device

Primary Outcome Measure

Percent of sessions completed [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115
Ethan Litman, MD,MS
[email protected]
617-667-3000
Chloe Zera, MD, MPH (PRINCIPAL_INVESTIGATOR)
Ethan Litman, MD,MS (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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