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Remote Fetal Monitoring in High Risk Pregnancies

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks
  • Procedures mentioned: Ultrasound, Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting."
  • "Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks."
  • "Cardiotocography (CTG), which uses Doppler ultrasound, is the gold standard for non-invasive FHR monitoring."
  • "Non-invasive fetal electrocardiography (NIFECG) is a form of electrocardiography (ECG), which captures simultaneous maternal and fetal PQRST waves."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether home monitoring with femomTM is practical and acceptable to people with high-risk pregnancies. It uses nonstress tests (NSTs), which check the baby's health, as an addition to regular pregnancy care. Participants will do three 30-minute sessions each week for 6 weeks, starting at 32 weeks of pregnancy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a pregnancy inside the womb that is more than 32 weeks along.
  • Have a pregnancy doctor who recommends testing the baby's health at least once a week.
  • Speak English.

Who can't join

  • Are younger than 18.
  • Do not speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MA