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Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development

Recruitingn/aAges any - anyAllFundació Sant Joan de Déu
NCT07033663 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy. These treatments are necessary for women with autoimmune, inflammatory, allergic, or cancer-related diseases who cannot stop their medication while pregnant. Why is it important? Although these treatments help keep the mother and baby healthy, some medications can cross the placenta and affect the baby's immune system. Since pregnant women are usually not included in clinical trials, the investigators still don't know exactly how these drugs might influence the baby's immune development. How will the investigators do it? The investigators will follow a group of pregnant women receiving these treatments and monitor their babies at birth, and at 3, 6, and 12 months. The study will take place in three leading hospi

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📋 Eligibility rules (as published)
Inclusion Criteria: Pregnant women with immune-mediated inflammatory or oncologic diseases, categorized into: 1. High-exposed group: monoclonal treatment throughout pregnancy. 2. Low-exposed group: monoclonal treatment limited to the first/second trimester. 3. Non-exposed group: No monoclonal exposure or treatment with non-placental-crossing biologics, serving as a control to distinguish immunological changes attributable to maternal disease. \-
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What it tests

  • Monoclonal antibody
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Where

3 sites
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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