Fetal-Hope Study: Home Monitoring of Fetal Heart Rate in SSA+ Pregnant Women
Launched by ASST FATEBENEFRATELLI SACCO · Jul 13, 2023
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
The Fetal-Hope Study is a clinical trial focused on pregnant women who have tested positive for certain antibodies (known as Ro-SSA antibodies) that can lead to heart problems in their babies. This study aims to see if using a special home device to monitor the fetal heart rate three times a day can help quickly identify any heart rhythm issues in the fetus. By catching these problems early, doctors can provide timely treatment, which may prevent serious complications like lifelong heart issues for the baby.
To participate in this study, women over 18 who are pregnant and have tested positive for Ro-SSA antibodies can enroll. There are no specific health restrictions preventing participation. If you join the trial, you will use a simple device at home to check your baby's heart rate, which will help ensure any potential issues are detected early. This could improve outcomes for both you and your baby, possibly becoming a new standard practice for monitoring fetal health in similar cases.
Gender
FEMALE
Eligibility 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
About Asst Fatebenefratelli Sacco
Asst Fatebenefratelli Sacco is a prominent healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a strong commitment to ethical standards and patient safety, the organization collaborates with leading researchers and healthcare professionals to explore new therapies and treatment options across various medical fields. Asst Fatebenefratelli Sacco leverages its extensive expertise and state-of-the-art facilities to contribute to the global body of medical knowledge, ultimately aiming to enhance the quality of care for patients both locally and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milano, , Italy
Patients applied
Trial Officials
Antonio Luca Brucato, Prof
Principal Investigator
ASST Fatebenefratelli, Milano, Italy
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported