Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)
1 other identifier
observational
1,750
1 country
73
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2018
CompletedFirst Posted
Study publicly available on registry
March 28, 2019
CompletedStudy Start
First participant enrolled
May 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
ExpectedFebruary 21, 2020
February 1, 2020
4.8 years
December 17, 2018
February 19, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
To calculate the incide rate of serious infections during pregnancy (evaluated and the end of pregnancy) based on the medications used to treat IBD.
To assess the prevalence of complications related to drugs used for IBD treatment for pregnancy.
9 months
To calculate the incide rate of serious infections for the offspring (at eh age of 4 years) based on the medications used to treat IBD.
To assess the prevalence of complications related to drugs used for IBD treatment for the offspring.
4 years
To calculate the incide rate of serious adverse events during pregnancy (evaluated at the end of pregnancy) based on the medications used to treat IBD.
To asses the prevalence of complications related to drugs used for IBD treatment for pregnancy.
9 months
To calculate the incide rate of serious adverse events during offspring (at the age of 4 years) based on the medications used to treat IBD.
To asses the prevalence of complications related to drugs used for IBD treatment for offspring mainly focused on the risck of serious infections at the age of 4 years.
4 years
Secondary Outcomes (5)
2. To calculate the Odds ratio of serious adverse events (including abortions) during pregnancy and delivery based on the drugs used for the treatment of IBD.
4 years and 9 months
3. To measure the developmental status of children born from IBD mothers with the ASQ-3 questionnaire during the first 4 years.
4 years and 9 months
4. To calculate the Hazard ratio of serious adverse events in children born from mothers with IBD who have been exposed in utero to different drugs to treat IBD with the risk in children who were not exposed.
4 years and 9 months
5. To calculate the proportion of children with malformations and to compare the proportions between exposure groups (children exposed to biologics with those non exposed to these drugs).
4 years and 9 months
6. To calculate the Hazard ratio of developing neoplasm in children exposed to drugs to treat IBD.
4 years and 9 months
Study Arms (3)
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.
Eligibility Criteria
Pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain.
You may qualify if:
- 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).
You may not qualify if:
- Patients who do not accept to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 35010, 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, 39008, 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, 46010, 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, 28006, Spain
Hospital Clínico San Carlos
Madrid, 28040, 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, 46010, Spain
Related Publications (23)
Gisbert JP. Safety of immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding. Inflamm Bowel Dis. 2010 May;16(5):881-95. doi: 10.1002/ibd.21154.
PMID: 19885906BACKGROUNDGisbert JP, Chaparro M. Safety of anti-TNF agents during pregnancy and breastfeeding in women with inflammatory bowel disease. Am J Gastroenterol. 2013 Sep;108(9):1426-38. doi: 10.1038/ajg.2013.171. Epub 2013 Jun 11.
PMID: 23752881BACKGROUNDBurisch J, Pedersen N, Cukovic-Cavka S, Turk N, Kaimakliotis I, Duricova D, Shonova O, Vind I, Avnstrom S, Thorsgaard N, Krabbe S, Andersen V, Dahlerup Jens F, Kjeldsen J, Salupere R, Olsen J, Nielsen KR, Manninen P, Collin P, Katsanos KH, Tsianos EV, Ladefoged K, Lakatos L, Bailey Y, O'Morain C, Schwartz D, Odes S, Martinato M, Lombardini S, Jonaitis L, Kupcinskas L, Turcan S, Barros L, Magro F, Lazar D, Goldis A, Nikulina I, Belousova E, Fernandez A, Hernandez V, Almer S, Zhulina Y, Halfvarson J, Tsai HH, Sebastian S, Lakatos PL, Langholz E, Munkholm P; EpiCom Group. Initial disease course and treatment in an inflammatory bowel disease inception cohort in Europe: the ECCO-EpiCom cohort. Inflamm Bowel Dis. 2014 Jan;20(1):36-46. doi: 10.1097/01.MIB.0000436277.13917.c4.
PMID: 24252978BACKGROUNDMix E, Goertsches R, Zett UK. Immunoglobulins--basic considerations. J Neurol. 2006 Sep;253 Suppl 5:V9-17. doi: 10.1007/s00415-006-5002-2.
PMID: 16998762BACKGROUNDIsrael EJ, Simister N, Freiberg E, Caplan A, Walker WA. Immunoglobulin G binding sites on the human foetal intestine: a possible mechanism for the passive transfer of immunity from mother to infant. Immunology. 1993 May;79(1):77-81.
PMID: 8509144BACKGROUNDChaparro M, Gisbert JP. Transplacental transfer of immunosuppressants and biologics used for the treatment of inflammatory bowel disease. Curr Pharm Biotechnol. 2011 May;12(5):765-73. doi: 10.2174/138920111795470903.
PMID: 21342120BACKGROUNDJulsgaard M, Christensen LA, Gibson PR, Gearry RB, Fallingborg J, Hvas CL, Bibby BM, Uldbjerg N, Connell WR, Rosella O, Grosen A, Brown SJ, Kjeldsen J, Wildt S, Svenningsen L, Sparrow MP, Walsh A, Connor SJ, Radford-Smith G, Lawrance IC, Andrews JM, Ellard K, Bell SJ. Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection. Gastroenterology. 2016 Jul;151(1):110-9. doi: 10.1053/j.gastro.2016.04.002. Epub 2016 Apr 8.
PMID: 27063728BACKGROUNDVermeire S, Carbonnel F, Coulie PG, Geenen V, Hazes JM, Masson PL, De Keyser F, Louis E. Management of inflammatory bowel disease in pregnancy. J Crohns Colitis. 2012 Sep;6(8):811-23. doi: 10.1016/j.crohns.2012.04.009. Epub 2012 May 16.
PMID: 22595185BACKGROUNDChaparro M, Verreth A, Lobaton T, Gravito-Soares E, Julsgaard M, Savarino E, Magro F, Biron AI, Lopez-Serrano P, Casanova MJ, Gompertz M, Vitor S, Arroyo M, Pugliese D, Zabana Y, Vicente R, Aguas M, Shitrit BA, Gutierrez A, Doherty GA, Fernandez-Salazar L, Cadilla MJ, Huguet JM, O'Toole A, Stasi E, Marcos MN, Villoria A, Karmiris K, Rahier JF, Rodriguez C, Palomares DM, Fiorino G, Benitez JM, Principi M, Naftali T, Taxonera C, Mantzaris G, Sebkova L, Iade B, Lissner D, Bradley FI, Roman LA, Marin-Jimenez I, Merino O, Sierra M, Van Domselaar M, Caprioli F, Guerra I, Peixe P, Piqueras M, Rodriguez-Lago I, Ber Y, van Hoeve K, Torres P, Gravito-Soares M, Rudbeck-Resdal D, Bartolo O, Peixoto A, Martin G, Armuzzi A, Garre A, Donday MG, de Carpi MFJ, Gisbert JP. Long-Term Safety of In Utero Exposure to Anti-TNFalpha Drugs for the Treatment of Inflammatory Bowel Disease: Results from the Multicenter European TEDDY Study. Am J Gastroenterol. 2018 Mar;113(3):396-403. doi: 10.1038/ajg.2017.501. Epub 2018 Feb 20.
PMID: 29460920BACKGROUNDDomenech E, Gisbert JP. Efficacy and safety of vedolizumab in the treatment of ulcerative colitis. Gastroenterol Hepatol. 2016 Dec;39(10):677-686. doi: 10.1016/j.gastrohep.2015.11.010. Epub 2016 Mar 2. English, Spanish.
PMID: 26948838BACKGROUNDGisbert JP, Domenech E. [Vedolizumab in the treatment of Crohn's disease]. Gastroenterol Hepatol. 2015 May;38(5):338-48. doi: 10.1016/j.gastrohep.2014.12.003. Epub 2015 Jan 23. Spanish.
PMID: 25619903BACKGROUNDBeaulieu DB, Ananthakrishnan AN, Martin C, Cohen RD, Kane SV, Mahadevan U. Use of Biologic Therapy by Pregnant Women With Inflammatory Bowel Disease Does Not Affect Infant Response to Vaccines. Clin Gastroenterol Hepatol. 2018 Jan;16(1):99-105. doi: 10.1016/j.cgh.2017.08.041. Epub 2017 Sep 1.
PMID: 28870657BACKGROUNDLahat A, Shitrit AB, Naftali T, Milgrom Y, Elyakim R, Goldin E, Levhar N, Selinger L, Zuker T, Fudim E, Picard O, Yavzori M, Ben-Horin S. Vedolizumab Levels in Breast Milk of Nursing Mothers With Inflammatory Bowel Disease. J Crohns Colitis. 2018 Jan 5;12(1):120-123. doi: 10.1093/ecco-jcc/jjx120.
PMID: 28961712BACKGROUNDJulsgaard M, Kjeldsen J, Bibby BM, Brock B, Baumgart DC. Vedolizumab Concentrations in the Breast Milk of Nursing Mothers With Inflammatory Bowel Disease. Gastroenterology. 2018 Feb;154(3):752-754.e1. doi: 10.1053/j.gastro.2017.08.067. Epub 2017 Oct 5. No abstract available.
PMID: 28988916BACKGROUNDMahadevan U, Vermeire S, Lasch K, Abhyankar B, Bhayat F, Blake A, Dubinsky M. Vedolizumab exposure in pregnancy: outcomes from clinical studies in inflammatory bowel disease. Aliment Pharmacol Ther. 2017 Apr;45(7):941-950. doi: 10.1111/apt.13960. Epub 2017 Feb 7.
PMID: 28169436BACKGROUNDGisbert JP, Chaparro M. Ustekinumab to treat Crohn's disease. Gastroenterol Hepatol. 2017 Dec;40(10):688-698. doi: 10.1016/j.gastrohep.2017.08.006. Epub 2017 Oct 16. English, Spanish.
PMID: 29042094BACKGROUNDRowan CR, Cullen G, Mulcahy HE, Keegan D, Byrne K, Murphy DJ, Sheridan J, Doherty GA. Ustekinumab Drug Levels in Maternal and Cord Blood in a Woman With Crohn's Disease Treated Until 33 Weeks of Gestation. J Crohns Colitis. 2018 Feb 28;12(3):376-378. doi: 10.1093/ecco-jcc/jjx141.
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PMID: 25602023BACKGROUNDBoyd HA, Basit S, Harpsoe MC, Wohlfahrt J, Jess T. Inflammatory Bowel Disease and Risk of Adverse Pregnancy Outcomes. PLoS One. 2015 Jun 17;10(6):e0129567. doi: 10.1371/journal.pone.0129567. eCollection 2015.
PMID: 26083614BACKGROUNDHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PMID: 18929686BACKGROUNDPalomino L, Velasco Rodriguez-Belvis M, Casanova MJ, Leo-Carnerero E, Calvino-Suarez C, Rivero M, Calvo M, Arroyo MT, Fernandez-Clotet A, Perez-Martinez I, Masedo Gonzalez A, Hernandez V, Ruiz-Cerulla A, Lopez Serrano P, Vega P, Rodriguez-Lago I, Lidon RV, De Jorge MA, Guerra I, Garcia LA, Molina Arriero G, Hervias Cruz D, Busquets D, Gutierrez Casbas A, Van Domselaar M, Valldosera Gomis G, Vazquez Moron JM, Piqueras Cano M, Lucendo AJ, Martin Arranz MD, Ramirez de la Piscina P, Martinez Tirado MDP, Robles Alonso V, Marin Pedrosa S, Camargo Camero R, Armesto Gonzalez E, Tardillo Marin C, Bernardos Martin E, Rodriguez Grau MC, Huguet JM, Marquez-Mosquera L, Sendra Rumbeu P, Bujanda L, Castano-Milla C, Sainz Arnau E, Hernandez L, Ramos L, Bosca-Watts MM, Mancenido Marcos N, Sans M, Morales VJ, Acosta D, Garre A, Munoz Codoceo R, Garcia-Salido A, Gisbert JP, Chaparro M; DUMBO study group of GETECCU. Psychomotor Development in Infants Following Maternal Exposure to Biologics: Results From the DUMBO Registry. Clin Gastroenterol Hepatol. 2025 Jun 13:S1542-3565(25)00488-4. doi: 10.1016/j.cgh.2025.05.012. Online ahead of print.
PMID: 40518059DERIVEDChaparro M, Donday MG, Abad-Santos F, Martin de Carpi FJ, Macia-Martinez MA, Montero D, Acosta D, Brenes Y, Gisbert JP. The safety of drugs for inflammatory bowel disease during pregnancy and breastfeeding: the DUMBO registry study protocol of GETECCU. Therap Adv Gastroenterol. 2021 Jun 3;14:17562848211018097. doi: 10.1177/17562848211018097. eCollection 2021.
PMID: 34158835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 57 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2018
First Posted
March 28, 2019
Study Start
May 21, 2019
Primary Completion
March 1, 2024
Study Completion (Estimated)
March 1, 2028
Last Updated
February 21, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share