Condition: Inflammatory Bowel Diseases · Pregnancy · Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
This is a prospective, observational, multicenter registry, which will enrol pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain. In addition, each incident gestation will be followed-up during pregnancy, and children born to those mothers will be followed-up over 4 years to determine the incidence of serious adverse events (such as alteration of developmental status, infections, neoplasia or any other serious adverse events) during the study period. In order to harmonize the inclusion of adverse events and complications, only serious adverse events will be registered . The main variable will be the development of serious infection in children as this is the outcome that had controversial results in previous studies.
This description comes directly from the study's public registry record.
María Chaparro, PhDMD · 913093911 · mariachs2005@gmail.com
María G Donday · 913093911 · mariagdonday@gmail.com
Always discuss trial participation with your own doctor first.
| 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 Infanta Elena | Huelva, Andalusia, Spain | Not Yet Recruiting |
| Hospital Universitario Juan Ramón Jimenez | Huelva, Andalusia, Spain | Recruiting |
| Hospital Regional Universitario de Málaga | Málaga, Andalusia, Spain | Not Yet Recruiting |
| Hospital Universitario Virgen de la Victoria | Málaga, Andalusia, Spain | Not Yet Recruiting |
| Hospital San Juan de Dios del Aljarafe | Seville, Andalusia, Spain | Not Yet Recruiting |
| Hospital Universitario Virgen del Rocío | Seville, Andalusia, Spain | Recruiting |
| Hospital San Jorge | Huesca, Aragon, Spain | Not Yet Recruiting |
| Hopsital Universitario Miguel Servet | Zaragoza, Aragon, Spain | Not Yet Recruiting |
| Hospital Clínico Universitario Lozano Blesa | Zaragoza, Aragon, Spain | Recruiting |
+ 61 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03894228