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Search / Trial NCT05958446

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 01, 2025

Recruiting

Keywords

Sjogren's Syndrome Ssa Sle Pregnancy Fetal Heart Rate Neonatal Lupus

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.

Locations

Milano, , Italy

Patients applied

0 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