Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
Recruiting now
Conditions studied: Pregnancy Related, Immune-mediated Diseases
In brief
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 hospitals in Spain: Hospital Sant Joan de Déu, Hospital Clínic, and Vall d'Hebron. The investigators will also use organoid models in the lab to better understand how these drugs affect fetal development. Who will benefit? This study will help parents concerned about the impact of treatments during pregnancy on their child's health. It will also give doctors the evidence they need to make safer treatment decisions, and support the creation of new clinical guidelines to protect both mothers and babies.
Key facts
- Study ID
- NCT07033663
- Run by
- Fundació Sant Joan de Déu
- People needed
- 90
- Starts
- 2018-06-01
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2025-08-15
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pregnant women with immune-mediated inflammatory or oncologic diseases, categorized into:
- High-exposed group: monoclonal treatment throughout pregnancy.
- Low-exposed group: monoclonal treatment limited to the first/second trimester.
- 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.
Where it is running
- Hospital Sant Joan de Déu — Esplugues de Llobregat, Barcelona, Spain (enrolling)
- Hospital Clínic de Barcelona — Barcelona, Spain (enrolling)
- Hospital Universitari Vall d'Hebrón — Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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