Actively Recruiting
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
Led by Fundació Sant Joan de Déu · Updated on 2025-08-15
90
Participants Needed
3
Research Sites
517 weeks
Total Duration
On this page
Sponsors
F
Fundació Sant Joan de Déu
Lead Sponsor
H
Hospital Clinic of Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with immune-mediated inflammatory or oncologic diseases
- Women receiving monoclonal antibody treatment throughout pregnancy (high-exposed group)
- Women receiving monoclonal antibody treatment limited to the first or second trimester (low-exposed group)
- Women with no monoclonal antibody exposure or treated with non-placental-crossing biologics (control group)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
2
Hospital Clínic de Barcelona
Barcelona, Spain, 08035
Actively Recruiting
3
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
Research Team
L
Laia Alsina, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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