Actively Recruiting
Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)
Led by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Updated on 2020-02-21
1750
Participants Needed
73
Research Sites
458 weeks
Total Duration
On this page
Sponsors
G
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Lead Sponsor
S
Spanish Agency of Medicines and Health Products
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age diagnosed with IBD.
- Confirmed pregnancy.
- Awareness of the pregnancy before the 28th week of gestation (end of second trimester).
You will not qualify if you...
- Patients who do not accept to participate in the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 73 locations
1
Complejo Hospitalario Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Actively Recruiting
2
Hospital Universitario Reina Sofía
Córdoba, Andalusia, Spain
Actively Recruiting
3
Hospital Clínico Universitario San Cecilio
Granada, Andalusia, Spain
Actively Recruiting
4
Hospital Infanta Elena
Huelva, Andalusia, Spain
Not Yet Recruiting
5
Hospital Universitario Juan Ramón Jimenez
Huelva, Andalusia, Spain
Actively Recruiting
6
Hospital Regional Universitario de Málaga
Málaga, Andalusia, Spain
Not Yet Recruiting
7
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Not Yet Recruiting
8
Hospital San Juan de Dios del Aljarafe
Seville, Andalusia, Spain
Not Yet Recruiting
9
Hospital Universitario Virgen del Rocío
Seville, Andalusia, Spain
Actively Recruiting
10
Hospital San Jorge
Huesca, Aragon, Spain
Not Yet Recruiting
11
Hopsital Universitario Miguel Servet
Zaragoza, Aragon, Spain
Not Yet Recruiting
12
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, Spain
Actively Recruiting
13
Hospital Royo Villanova
Zaragoza, Aragon, Spain
Not Yet Recruiting
14
Hospital Comaral de Inca
Palma de Mallorca, Balearic Islands, Spain
Not Yet Recruiting
15
Hospital Universitario de Son Espases
Palma de Mallorca, Balearic Islands, Spain
Actively Recruiting
16
Hospital Universitario de Álava
Alava, Basque Country, Spain
Actively Recruiting
17
Hospital Universitario de Donostia
Donostia / San Sebastian, Basque Country, Spain
Actively Recruiting
18
Hospital de Galdakao-Usansolo
Galdakao, Basque Country, Spain
Actively Recruiting
19
Hospital Doctor Negrin
Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
Not Yet Recruiting
20
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Actively Recruiting
21
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Canary Islands, Spain
Not Yet Recruiting
22
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
23
Hospital General de Castellon
Castellon, Castellón, Spain
Not Yet Recruiting
24
Hospital Santos Reyes
Burgos, Castille and León, Spain
Not Yet Recruiting
25
Hospital Universitario de Burgos
Burgos, Castille and León, Spain
Not Yet Recruiting
26
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
Not Yet Recruiting
27
Hospital Clínico de Valladolid
Valladolid, Castille and León, Spain
Not Yet Recruiting
28
Hospital Provincial de Zamora
Zamora, Castille and León, Spain
Not Yet Recruiting
29
Hospital Virgen de la Concha
Zamora, Castille and León, Spain
Not Yet Recruiting
30
Hospital Alcázar de San Juan
Ciudad Real, Castille-La Mancha, Spain
Not Yet Recruiting
31
Hospital General de Tomelloso
Ciudad Real, Castille-La Mancha, Spain
Actively Recruiting
32
Hospital General Universitario de Ciudad Real
Ciudad Real, Castille-La Mancha, Spain
Actively Recruiting
33
Hospital Virgen de la Salud
Toledo, Castille-La Mancha, Spain
Not Yet Recruiting
34
Hospital del Mar
Barcelona, Catalonia, Spain
Not Yet Recruiting
35
Hospital Universitario Clinic i Provincial
Barcelona, Catalonia, Spain
Actively Recruiting
36
Hospital Universitario de Bellvitge
Barcelona, Catalonia, Spain
Actively Recruiting
37
Hospital Vall d´Hebron
Barcelona, Catalonia, Spain
Not Yet Recruiting
38
Hospital Universitari Dr Josep Trueta
Girona, Catalonia, Spain
Not Yet Recruiting
39
Hospital Sant Joan de Déu
Manresa, Catalonia, Spain
Not Yet Recruiting
40
Consorci Sanitari de Terrassa
Tarragona, Catalonia, Spain
Not Yet Recruiting
41
Hospital Joan XXIII
Tarragona, Catalonia, Spain
Actively Recruiting
42
Hospital Universitari Sant Joan de Reus
Tarragona, Catalonia, Spain
Not Yet Recruiting
43
Hospital San Pedro Alcántara
Cáceres, Extremadura, Spain
Not Yet Recruiting
44
Complexo Hospitalario Universitario de A Coruña
A Coruña, Galicia, Spain
Actively Recruiting
45
Complejo Hospitalario Universitario de Ferrol
Ferrol, Galicia, Spain
Actively Recruiting
46
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, Spain
Not Yet Recruiting
47
Hospital Alvaro Cunqueiro
Vigo, Galicia, Spain
Actively Recruiting
48
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Actively Recruiting
49
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Actively Recruiting
50
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Not Yet Recruiting
51
Hosptial Universitario Infanta Cristina
Parla, Madrid, Spain
Not Yet Recruiting
52
Hospital del Henares
San Fernando de Henares, Madrid, Spain
Actively Recruiting
53
Hospital Universitario de Torrejón
Torrejón, Madrid, Spain
Actively Recruiting
54
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Actively Recruiting
55
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Actively Recruiting
56
Hospital General Universitario de Alicante
Alicante, Valencia, Spain
Actively Recruiting
57
Hospital Marina Baixa de Villajoyosa
Alicante, Valencia, Spain
Not Yet Recruiting
58
Hospital Universitario San Juan
Alicante, Valencia, Spain
Not Yet Recruiting
59
Hospital General Universitario de Valencia
Valencia, Valencia, Spain, 46010
Not Yet Recruiting
60
Hospital Lluis Alcanyís de Xátiva
Valencia, Valencia, Spain
Not Yet Recruiting
61
Hospital Universitàri i Politècnic La Fe
Valencia, Valencia, Spain
Not Yet Recruiting
62
Hospital de Granollers
Barcelona, Spain
Not Yet Recruiting
63
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
64
Hospital Clínico San Carlos
Madrid, Spain, 28040
Not Yet Recruiting
65
Hospital Universitario de La Paz
Madrid, Spain
Actively Recruiting
66
Hospital Universitario Doce de Octubre
Madrid, Spain
Not Yet Recruiting
67
Hospital Universitario Gregorio Marañón
Madrid, Spain
Not Yet Recruiting
68
Hospital Universitario Infanta Leonor
Madrid, Spain
Not Yet Recruiting
69
Hospital Universitario Infanta Sofía
Madrid, Spain
Actively Recruiting
70
Hospital Universitario Rey Juan Carlos
Madrid, Spain
Actively Recruiting
71
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Not Yet Recruiting
72
Hospital Universitario Virgen del Rosell
Murcia, Spain
Not Yet Recruiting
73
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Not Yet Recruiting
Research Team
M
María Chaparro, PhDMD
CONTACT
M
María G Donday
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here