Home monitoring of fetal heart rate in pregnant women with autoimmune diseases
Home Monitoring of Fetal Heart Rhythm in Pregnancies of Anti-Ro/SSA Positive Women for the Treatment of Congenital Heart Block (FETAL HOPE)
This study is testing whether home monitoring of fetal heart rates can help pregnant women with autoimmune diseases catch any heart problems in their babies earlier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | ASST Fatebenefratelli Sacco Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT05958446 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on pregnant women who are positive for anti-Ro/SSA antibodies, which are associated with autoimmune diseases like Sjögren's Syndrome and systemic lupus erythematosus. The study aims to monitor fetal heart rates at home to identify potential cardiac abnormalities in fetuses, particularly atrioventricular block, which can occur in these pregnancies. Current methods of fetal monitoring, such as ultrasound, are limited in frequency and may not detect rapid changes in fetal heart rhythm, making timely intervention challenging. By utilizing home monitoring, the study seeks to improve the early detection of these conditions and enhance patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over the age of 18 who are positive for anti-Ro/SSA antibodies.
Not a fit: Patients who are not pregnant or do not have a positive test for anti-Ro/SSA antibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of severe fetal cardiac complications and improve neonatal outcomes for affected pregnancies.
How similar studies have performed: While the approach of home monitoring is innovative, similar studies focusing on fetal heart rate monitoring in high-risk pregnancies have shown promise in improving outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients over the age of 18 will be enrolled in the study, who will sign the informed consent for participation in the study, characterized by the positivity of autoantibodies against Ro/SSA who will become pregnant during the enrollment period in the enrolling centres. Exclusion Criteria: * None
Where this trial is running
Milano
- ASST Fatebenefratelli e Sacco — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Antonio Luca Brucato, Prof — ASST Fatebenefratelli, Milano, Italy
- Study coordinator: Emanuele Bizzi, Dr
- Email: bizzi.emanuele@gmail.com
- Phone: +393299636442
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.