NCT07033663 Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
| NCT ID | NCT07033663 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundació Sant Joan de Déu |
| Condition | Pregnancy Related |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2018-06-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2018-06-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07033663 clinical trial?
This trial is open to participants of all sexes, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07033663 currently recruiting?
Yes, NCT07033663 is actively recruiting participants. Contact the research team at frecerca.aro@sjd.es for enrollment information.
Where is the NCT07033663 trial being conducted?
This trial is being conducted at Esplugues de Llobregat, Spain, Barcelona, Spain, Barcelona, Spain.
Who is sponsoring the NCT07033663 clinical trial?
NCT07033663 is sponsored by Fundació Sant Joan de Déu. The trial plans to enroll 90 participants.