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

Status: Recruiting
Location: See all (73) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Spain
Complexo Hospitalario Universitario de A Coruña
RECRUITING
A Coruña
Hospital Universitario de Álava
RECRUITING
Alava
Hospital Universitario Fundación Alcorcón
RECRUITING
Alcorcón
Hospital General Universitario de Alicante
RECRUITING
Alicante
Hospital Marina Baixa de Villajoyosa
NOT_YET_RECRUITING
Alicante
Hospital Universitario San Juan
NOT_YET_RECRUITING
Alicante
Hospital de Granollers
NOT_YET_RECRUITING
Barcelona
Hospital del Mar
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Clinic i Provincial
RECRUITING
Barcelona
Hospital Universitario de Bellvitge
RECRUITING
Barcelona
Hospital Vall d´Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Santos Reyes
NOT_YET_RECRUITING
Burgos
Hospital Universitario de Burgos
NOT_YET_RECRUITING
Burgos
Hospital San Pedro Alcántara
NOT_YET_RECRUITING
Cáceres
Hospital General de Castellon
NOT_YET_RECRUITING
Castellon
Hospital Alcázar de San Juan
NOT_YET_RECRUITING
Ciudad Real
Hospital General de Tomelloso
RECRUITING
Ciudad Real
Hospital General Universitario de Ciudad Real
RECRUITING
Ciudad Real
Hospital Universitario Reina Sofía
RECRUITING
Córdoba
Hospital Universitario de Donostia
RECRUITING
Donostia / San Sebastian
Complejo Hospitalario Universitario de Ferrol
RECRUITING
Ferrol
Hospital Universitario de Fuenlabrada
RECRUITING
Fuenlabrada
Hospital de Galdakao-Usansolo
RECRUITING
Galdakao
Hospital Universitari Dr Josep Trueta
NOT_YET_RECRUITING
Girona
Hospital Clínico Universitario San Cecilio
RECRUITING
Granada
Hospital Infanta Elena
NOT_YET_RECRUITING
Huelva
Hospital Universitario Juan Ramón Jimenez
RECRUITING
Huelva
Hospital San Jorge
NOT_YET_RECRUITING
Huesca
Hospital Doctor Negrin
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital Clínico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario de La Paz
RECRUITING
Madrid
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario Doce de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Hospital Universitario Infanta Leonor
NOT_YET_RECRUITING
Madrid
Hospital Universitario Infanta Sofía
RECRUITING
Madrid
Hospital Universitario Rey Juan Carlos
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
NOT_YET_RECRUITING
Majadahonda
Hospital Regional Universitario de Málaga
NOT_YET_RECRUITING
Málaga
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
Hospital Sant Joan de Déu
NOT_YET_RECRUITING
Manresa
Hospital Universitario Virgen de la Arrixaca
NOT_YET_RECRUITING
Murcia
Hospital Universitario Virgen del Rosell
NOT_YET_RECRUITING
Murcia
Complexo Hospitalario Universitario de Ourense
NOT_YET_RECRUITING
Ourense
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Comaral de Inca
NOT_YET_RECRUITING
Palma De Mallorca
Hospital Universitario de Son Espases
RECRUITING
Palma De Mallorca
Complejo Hospitalario de Navarra
RECRUITING
Pamplona
Hosptial Universitario Infanta Cristina
NOT_YET_RECRUITING
Parla
Hospital Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
Hospital del Henares
RECRUITING
San Fernando De Henares
Hospital Universitario de Canarias
RECRUITING
Santa Cruz De Tenerife
Hospital Universitario Nuestra Señora de la Candelaria
NOT_YET_RECRUITING
Santa Cruz De Tenerife
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Complejo Hospitalario Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital San Juan de Dios del Aljarafe
NOT_YET_RECRUITING
Seville
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Consorci Sanitari de Terrassa
NOT_YET_RECRUITING
Tarragona
Hospital Joan XXIII
RECRUITING
Tarragona
Hospital Universitari Sant Joan de Reus
NOT_YET_RECRUITING
Tarragona
Hospital Virgen de la Salud
NOT_YET_RECRUITING
Toledo
Hospital Universitario de Torrejón
RECRUITING
Torrejón
Hospital Clínico Universitario de Valencia
NOT_YET_RECRUITING
Valencia
Hospital General Universitario de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Lluis Alcanyís de Xátiva
NOT_YET_RECRUITING
Valencia
Hospital Universitàri i Politècnic La Fe
NOT_YET_RECRUITING
Valencia
Hospital Clínico de Valladolid
NOT_YET_RECRUITING
Valladolid
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Hospital Provincial de Zamora
NOT_YET_RECRUITING
Zamora
Hospital Virgen de la Concha
NOT_YET_RECRUITING
Zamora
Hopsital Universitario Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Hospital Royo Villanova
NOT_YET_RECRUITING
Zaragoza
Contact Information
Primary
María Chaparro, PhDMD
mariachs2005@gmail.com
913093911
Backup
María G Donday
mariagdonday@gmail.com
913093911
Time Frame
Start Date: 2019-05-21
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 1750
Treatments
Biologics exposed cohort
Children born from mothers treated with biologic drugs (with or without immunomodulators) at any time during pregnancy or the three months before conception. Biologic drugs are IgG monoclonal antibodies able to cross the placenta.
Immunomodulators exposed cohort
Children born from mothers treated with immunomodulators (without biologics) during pregnancy or the three months before conception.
Non-exposed cohort
Children born from mothers treated neither with biologic drugs nor with immunomodulators at any time during pregnancy or the three months before conception.
Related Therapeutic Areas
Sponsors
Collaborators: Spanish Agency of Medicines and Health Products
Leads: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

This content was sourced from clinicaltrials.gov