COVID-19 infection and medicines in pregnancy – a multinational registry based study Medication use in pregnant women with COVID-19: an interim report
Creators
- 1. UiO
- 2. UMC
- 3. Instituto Aragones de Ciencias de la Salud (IACS)
- 4. FISABIO-HSRU
- 5. Swansea University
- 6. ARS
Description
In the current pandemic, pregnant women are becoming infected with the SARS-CoV-2 virus and being treated for COVID-19 disease and its complications. EMA wishes to be prepared for situations where questions arise regarding the impact of medicine used for COVID-19 during pregnancy, on the unborn child. To answer such questions, insight is needed into drug utilisation in COVID-19 affected pregnancies compared with other pregnancies. The regulatory network will be better placed to judge the appropriateness of use in pregnancy, as well as the appropriateness of any proposed pregnancy-related risk minimisation measures, with better insight into how the disease, and treatments currently used, affect the pregnant woman and her infant.
The CONSIGN project is funded by the European Medicines Agency (EMA) (specific contract 04 implementing framework contract No EMA//28/PE, Lot 4) to undertake this research.
The project has led to the establishment of a new collaboration of over thirty researchers, harnessing data from nine electronic health care registries in eight European countries (Denmark (DK), Germany (DE), France (FR), Italy (IT), Norway (NO), Spain (ES), Sweden (SE), United Kingdom (UK)). Data sources include general practice databases (e.g. UK, ES), claims databases (FR, DE) and record linkage of demographic data, registers and dispensing (SE, NO, DK, IT, ES).
This interim report is the first from this new collaboration.
Files
CONSIGN WP1_INTERIM_REPORT_FINAL.pdf
Files
(1.0 MB)
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