Safety of IBD medications during pregnancy and breastfeeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry will enroll pregnant women diagnosed with inflammatory bowel diseases (IBD) in Spain over a five-year period. The study aims to follow these women throughout their pregnancies and monitor their children for four years to assess the incidence of serious adverse events, particularly focusing on serious infections. The research will compare outcomes between children exposed to IBD medications in utero and those who were not, evaluating risks such as developmental issues and malformations. The main goal is to clarify the safety of IBD treatments during pregnancy for both mothers and their offspring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients over 18 years of age diagnosed with IBD.
* Confirmed pregnancy.
* Awareness of the pregnancy (by the researcher) before week 28th of gestation (the end of the second trimester).

Exclusion Criteria:

• Patients who do not accept to participate in the study.

Where it's running

• Complejo Hospitalario Santiago de Compostela
  Santiago de Compostela, A Coruña, Spain Recruiting
• Hospital Universitario Reina Sofía
  Córdoba, Andalusia, Spain Recruiting
• Hospital Clínico Universitario San Cecilio
  Granada, Andalusia, Spain Recruiting
• Hospital Universitario Juan Ramón Jimenez
  Huelva, Andalusia, Spain Recruiting
• Hospital Universitario Virgen del Rocío
  Seville, Andalusia, Spain Recruiting
• Hospital Clínico Universitario Lozano Blesa
  Zaragoza, Aragon, Spain Recruiting

+23 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: María Chaparro, PhDMD
• Email: mariachs2005@gmail.com
• Phone: 913093911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.