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

NCT07033663 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-08-15

No results posted yet for this study

Summary

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

Interventions

DRUG

Monoclonal antibody

non-intervention. Drug used in clinical practice as per practitioner decision

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Hospital Vall d'Hebron

    collaborator OTHER

  • Fundació Sant Joan de Déu

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2027-12-01
Completion
2028-05-01
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033663 on ClinicalTrials.gov