Remote monitoring of fetal health in high-risk pregnancies
Investigating the Acceptability and Feasibility of Remote Fetal Monitoring in a High Risk Obstetric Population
This study is testing if women with high-risk pregnancies can safely monitor their baby's heart rate at home using a special device to see if it helps improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06822439 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility and acceptability of conducting nonstress tests (NSTs) at home for women with high-risk pregnancies. Participants will use a non-invasive fetal electrocardiography device to monitor fetal heart rate three times a week starting at 32 weeks of gestation. The goal is to determine if this home monitoring can supplement routine prenatal care and alleviate the burden on healthcare providers. The study aims to address access to care issues and improve the management of high-risk pregnancies.
Who should consider this trial
Good fit: Ideal candidates are English-speaking women with intrauterine pregnancies greater than 32 weeks gestation who are recommended for weekly antenatal fetal testing.
Not a fit: Patients under 18 years old or non-English speakers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance prenatal care accessibility and improve fetal monitoring for women with high-risk pregnancies.
How similar studies have performed: While non-invasive fetal monitoring has been primarily limited to research, there is potential for success based on advancements in technology and previous studies exploring remote monitoring.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Ethan Litman, MD, MS
- Email: elitman@bidmc.harvard.edu
- Phone: 617-677-3000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.