Health TrialsbyHealthPanel

Remote Fetal Monitoring in High Risk Pregnancies

ConditionsHigh Risk PregnancyRemote Patient MonitoringDiabetesHypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorBeth Israel Deaconess Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Intrauterine pregnancy greater than 32 weeks gestation

Recommended for at least once weekly antenatal fetal testing by their obstetrician

English-speaking

Disqualifiers

Under age 18 years of old

Non-english speaking

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Fetal ECG monitoring

    Device

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Remote Monitoring1 intervention

Trial outcomes

Primary outcomes

1

Percent of sessions completed

Percentage of completed remote monitoring sessions

Time frame
6 weeks
2

Percentage of interpretable sessions

Percentage of interpretable monitoring sesions

Time frame
6 weeks

Secondary outcomes

1

Patient satisfaction

Patient satisfaction with device using a Likert rating scale (range 1 - 5)

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

Biorithm Pte Ltd

Collaborator

Source ClinicalTrials.gov
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