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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
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
Conditions
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