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

Launched by FUNDACIÓ SANT JOAN DE DÉU · Jun 13, 2025

Keywords

ClinConnect Summary

This study is looking at how certain medications taken by pregnant women to treat immune-related diseases—like autoimmune conditions, allergies, inflammation, or cancer—might affect the development of their baby’s immune system. These medicines are important because they help keep the mother healthy, but some can pass through the placenta and may influence how the baby’s immune system grows. Since pregnant women are often not included in clinical trials, doctors don’t yet fully understand the effects these drugs might have on newborns.

The trial is open to pregnant women who have immune-related or cancer conditions and who are either taking these special medications throughout pregnancy, only during part of pregnancy, or not at all (to serve as a comparison). Participants will be followed from pregnancy through their baby’s first year, with check-ups at birth, 3, 6, and 12 months to see how the baby’s immune system is developing. The study will take place in three hospitals in Spain, and researchers will also study cells in the lab to learn more about how the medicines affect fetal growth. This research aims to give families and doctors clearer information about the safety of these treatments during pregnancy and help guide better care for both mothers and their babies.

Gender

ALL

Eligibility criteria

• 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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