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RECRUITING
NCT03894228

Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)

Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1750

Start Date

2019-05-21

Completion Date

2028-03-01

Last Updated

2020-02-21

Healthy Volunteers

No

Locations (73)

Complejo Hospitalario Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Hospital Universitario Reina Sofía

Córdoba, Andalusia, Spain

Hospital Clínico Universitario San Cecilio

Granada, Andalusia, Spain

Hospital Infanta Elena

Huelva, Andalusia, Spain

Hospital Universitario Juan Ramón Jimenez

Huelva, Andalusia, Spain

Hospital Regional Universitario de Málaga

Málaga, Andalusia, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Hospital San Juan de Dios del Aljarafe

Seville, Andalusia, Spain

Hospital Universitario Virgen del Rocío

Seville, Andalusia, Spain

Hospital San Jorge

Huesca, Aragon, Spain

Hopsital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

Hospital Royo Villanova

Zaragoza, Aragon, Spain

Hospital Comaral de Inca

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario de Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario de Álava

Alava, Basque Country, Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, Basque Country, Spain

Hospital de Galdakao-Usansolo

Galdakao, Basque Country, Spain

Hospital Doctor Negrin

Las Palmas de Gran Canaria, Canary Islands, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Hospital Universitario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Canary Islands, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital General de Castellon

Castellon, Castellón, Spain

Hospital Santos Reyes

Burgos, Castille and León, Spain

Hospital Universitario de Burgos

Burgos, Castille and León, Spain

Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

Hospital Clínico de Valladolid

Valladolid, Castille and León, Spain

Hospital Provincial de Zamora

Zamora, Castille and León, Spain

Hospital Virgen de la Concha

Zamora, Castille and León, Spain

Hospital Alcázar de San Juan

Ciudad Real, Castille-La Mancha, Spain

Hospital General de Tomelloso

Ciudad Real, Castille-La Mancha, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Castille-La Mancha, Spain

Hospital Virgen de la Salud

Toledo, Castille-La Mancha, Spain

Hospital del Mar

Barcelona, Catalonia, Spain

Hospital Universitario Clinic i Provincial

Barcelona, Catalonia, Spain

Hospital Universitario de Bellvitge

Barcelona, Catalonia, Spain

Hospital Vall d´Hebron

Barcelona, Catalonia, Spain

Hospital Universitari Dr Josep Trueta

Girona, Catalonia, Spain

Hospital Sant Joan de Déu

Manresa, Catalonia, Spain

Consorci Sanitari de Terrassa

Tarragona, Catalonia, Spain

Hospital Joan XXIII

Tarragona, Catalonia, Spain

Hospital Universitari Sant Joan de Reus

Tarragona, Catalonia, Spain

Hospital San Pedro Alcántara

Cáceres, Extremadura, Spain

Complexo Hospitalario Universitario de A Coruña

A Coruña, Galicia, Spain

Complejo Hospitalario Universitario de Ferrol

Ferrol, Galicia, Spain

Complexo Hospitalario Universitario de Ourense

Ourense, Galicia, Spain

Hospital Alvaro Cunqueiro

Vigo, Galicia, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hosptial Universitario Infanta Cristina

Parla, Madrid, Spain

Hospital del Henares

San Fernando de Henares, Madrid, Spain

Hospital Universitario de Torrejón

Torrejón, Madrid, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital General Universitario de Alicante

Alicante, Valencia, Spain

Hospital Marina Baixa de Villajoyosa

Alicante, Valencia, Spain

Hospital Universitario San Juan

Alicante, Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Hospital Lluis Alcanyís de Xátiva

Valencia, Valencia, Spain

Hospital Universitàri i Politècnic La Fe

Valencia, Valencia, Spain

Hospital de Granollers

Barcelona, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario de La Paz

Madrid, Spain

Hospital Universitario Doce de Octubre

Madrid, Spain

Hospital Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Universitario Infanta Sofía

Madrid, Spain

Hospital Universitario Rey Juan Carlos

Madrid, Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital Universitario Virgen del Rosell

Murcia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain