Study on impact of COVID-19 infection and medicines in pregnancy (CONSIGN)
For more information on this project, please contact the EU PE&PV research network at eupepv@uu.nl.
Project information
- EU PE&PV research network
- EUPAS40489
- EUPAS40317
- EUPAS39438
- EUPAS39226
- Specific Contract 04 implementing Framework service contract EMA/2018/28/PE
Full title
Study on impact of COVID-19 infection and medicines in pregnancy (CONSIGN)
Principal investigator
Prof. Dr. Miriam Sturkenboom, University Medical Center Utrecht
Participating organisations
- Utrecht University, The Netherlands - consortium lead
- UMC Utrecht, The Netherlands - coordinator
- Aarhus University, Denmark
- University of Copenhagen, Denmark
- Bordeaux Pharmacoepi, France
- ARS, Italy
- University of Oslo, Norway
- FICF, Spain
- IACS, Spain
- RTI Health Solutions, Spain
- Karolinska Institutet, Sweden
- University of Bern, Switzerland
- University of Manchester, UK
- University of Swansea, UK
Status
Completed (2023)
Deliverables
- Study protocol (WP1 EHR data)
- Study protocol (WP2 COVI-PREG)
- Description of international collaboration
- Study protocol (international meta-analysis)
- Study reports are available on the Zenodo CONSIGN community
Peer-reviewed scientific publications
- COVID-19-related medicine utilization study in pregnancy: The COVI-PREG cohort. Favre G, Gerbier E, Maisonneuve E, Pomar L, Winterfeld U, Lepigeon K, Bloemenkamp KWM, de Bruin O, Hurley E, Nordeng H, Siiskonen SJ, Sturkenboom MCJM, Baud D, Panchaud A; COVI-PREG and CONSIGN group. Br J Clin Pharmacol. 2023 May;89(5):1560-1574. doi: 10.1111/bcp.15611. Epub 2022 Dec 16. PMID: 36417423.
- Variations across Europe in hospitalization and management of pregnant women with SARS-CoV-2 during the initial phase of the pandemic: Multi-national population-based cohort study using the International Network of Obstetric Survey Systems (INOSS). de Bruin O, Engjom H, Vousden N, Ramakrishnan R, Aabakke AJM, Äyräs O, Donati S, Jónasdóttir E, Knight M, Overtoom EM, Salvatore MA, Sturkenboom MCJM, Svanvik T, Varpula R, Vercoutere A, Bloemenkamp KWM; INOSS COVID-19 Working Group. Acta Obstet Gynecol Scand. 2023 Nov;102(11):1521-1530. doi: 10.1111/aogs.14643. Epub 2023 Aug 18. PMID: 37594175; PMCID: PMC10577630.
- Evolution of National Guidelines on Medicines Used to Treat COVID-19 in Pregnancy in 2020-2022: A Scoping Review. Maisonneuve E, de Bruin O, Favre G, Goncé A, Donati S, Engjom H, Hurley E, Al-Fadel N, Siiskonen S, Bloemenkamp K, Nordeng H, Sturkenboom M, Baud D, Panchaud A. J Clin Med. 2023 Jul 6;12(13):4519. doi: 10.3390/jcm12134519. PMID: 37445553; PMCID: PMC10342271.
- COVID-19 and pregnancy: A European study on pre- and post-infection medication use. Hurley E, Geisler BP, Lupattelli A, Poblador-Plou B, Lassalle R, Jové J, Bernard MA, Sakr D, Sanfélix-Gimeno G, Sánchez-Saez F, Rodríguez-Bernal CL, Sabaté M, Ballarín E, Aguilera C, Jordan S, Thayer D, Farr I, Ahmed S, Bartolini C, Limoncella G, Paoletti O, Gini R, Maglanoc LA, Dudukina E, Ehrenstein V, Alsina E, Vaz TA, Riera-Arnau J, Sturkenboom MCJM, Nordeng HME. Eur J Clin Pharmacol. 2024 Feb 12. doi: 10.1007/s00228-024-03639-z. Epub ahead of print. PMID: 38347228.
- Neurodevelopmental outcomes of infants after in utero exposure to SARS-CoV-2 or mRNA-COVID-19 vaccine compared with unexposed infants: a COVI-PREG prospective cohort study. Favre G, Bromley RL, Bluett-Duncan M, Maisonneuve E, Pomar L, Daire C, Radan AP, Raio L, Surbek D, Blume C, Kalimeris S, Madec Y, Schneider J, Bickle Graz M, Winterfeld U, Panchaud A, Baud D. Clin Microbiol Infect. 2025 Feb;31(2):266-273. doi: 10.1016/j.cmi.2024.10.019. Epub 2024 Oct 23. PMID: 39454753.
CONSIGN International
- How COVID-19 Treatment in Pregnancy Reflects Healthcare Utilization During a Pandemic: A Two-Stage Individual Participant Data Meta-Analysis Combining Case-Based Registries. Maisonneuve E, De Bruin O, Favre G, Oakley E, Kim JYH, Farooq F, Al-Fadel N, Almutairi A, Del Mar Gil M, Fernandez Buhigas I, Visentin S, Cosmi E, Surita F, Souza RT, Cecatti JG, Costa ML, Sanin-Blair J, Tolosa JE, Hadar E, Goncé A, Poncelet C, Forestier F, Quibel T, Martinez de Tejada B, Eggel-Hort B, Capoccia Brugger R, Surbek D, Raio L, Radan AP, Todesco-Bernasconi M, Monod C, Schäffer L, Harnadi A, Mousavi SH, Ayres-de-Campos D, Pomar L, Sichitiu J, Salomon LJ, Ville Y, Papadia A, Rossier MC, Schuler-Faccini L, Goncalves Pereira N, Etchegaray A, Nieto-Calvache AJ, Geary M, Fuenzalida J, Grawe C, Ko AI, Johann S, De Santis M, Voekt CA, Hcini N, Nielsen-Saines K, Garabedian C, Sentilhes L, May Feuerschuette OH, Vetter G, Wardhana MP, Dajti I, Bloemenkamp KWM, Siiskonen SJ, Smith ER, Baud D, Panchaud A, Sturkenboom MCJM. Pharmacoepidemiol Drug Saf. 2025 Jul;34(7):e70180. doi: 10.1002/pds.70180. PMID: 40665803; PMCID: PMC12418691.
- Adverse outcomes among pregnant women with COVID-19 according to hospitalization status: A prospective individual participant data meta-analysis in Europe and North America.de Bruin O, Maisonneuve E, Hurley E, Nordeng HME, Bérard A, Sheehy O, Kaul P, Shinde MU, Cosgrove A, Lyons JG, Messenger-Jones E, Kempner ME, Toh S, Hua W, Hernández-Muñoz JJ, Sahin L, Cesta CE, Hägg D, Gini R, Paoletti O, Poblador-Plou B, Jordan S, Rodríguez-Bernal CL, Sánchez-Sáez F, Lassalle R, Bernard MA, Ahmadizar F, Favre G, Panchaud A, Bloemenkamp KWM, Plueschke K, de Vries C, Siiskonen SJ, Sturkenboom MCJM; CONSIGN Collaboration Group. Int J Gynaecol Obstet. 2025 Dec 15. doi: 10.1002/ijgo.70694. PMID: 41392882.
- Medications Used Among Nonhospitalized Pregnant Women With COVID-19: A Prospective Individual Patient Data Meta-Analysis in Europe and North America. de Bruin O, Maisonneuve E, Hurley E, Nordeng HME, Bérard A, Sheehy O, Kaul P, Shinde MU, Cosgrove A, Lyons JG, Messenger-Jones E, Kempner ME, Toh S, Hua W, Hernández-Muñoz JJ, Sahin L, Cesta CE, Hägg D, Gini R, Paoletti O, Poblador-Plou B, Jordan S, Thayer D, Rodríguez-Bernal CL, Sánchez-Sáez F, Lassalle R, Bernard MA, Alsina E, Ahmadizar F, Favre G, Panchaud A, Bloemenkamp KWM, Plueschke K, de Vries C, Siiskonen SJ, Sturkenboom MCJM; CONSIGN Collaboration Group. Pharmacoepidemiol Drug Saf. 2026 Jan;35(1):e70303. doi: 10.1002/pds.70303. PMID: 41449787; PMCID: PMC12741507.