Recruiting

Remote Monitoring

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06822439

Conditions

High Risk Pregnancy

Remote Patient Monitoring

Diabetes

Hypertension

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fetal ECG monitoring

Study Details

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

Study ID

NCT06822439

Start date

May 1, 2025

Status verified date

Mar, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Remote Monitoring

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

Interventions

Fetal ECG monitoring

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

Primary outcome measure

  • Percent of sessions completed [ Time Frame: 6 weeks ]
  • Percentage of interpretable sessions [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Chloe Zera, MD, MPH

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • Pregnancy
  • Non invasive testing
  • Remote patient monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-03-09.