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The lack of inclusion of pregnant women in clinical trials evaluating the effectiveness of medicines to treat COVID-19 has made it difficult to establish evidence-based treatment guidelines for pregnant women. Our aim was to provide a review of the evolution and updates of the national guidelines on medicines used in pregnant women with COVID-19 published by the obstetrician and gynecologists' societies in thirteen countries in 2020-2022. Based on the results of the RECOVERY (Randomized Evaluation of COVID-19 Therapy) trial, the national societies successively recommended against prescribing hydroxychloroquine, lopinavir-ritonavir and azithromycin. Guidelines for remdesivir differed completely between countries, from compassionate or conditional use to recommendation against. Nirmatrelvir-ritonavir was authorized in Australia and the UK only in research settings and was no longer recommended in the UK at the end of 2022. After initial reluctance to use corticosteroids, the results of the RECOVERY trial have enabled the recommendation of dexamethasone in case of severe COVID-19 since mid-2020. Some societies recommended prescribing tocilizumab to pregnant patients with hypoxia and systemic inflammation from June 2021. Anti-SARS-CoV-2 monoclonal antibodies were authorized at the end of 2021 with conditional use in some countries, and then no longer recommended in Belgium and the USA at the end of 2022. The gradual convergence of the recommendations, although delayed compared to the general population, highlights the importance of the inclusion of pregnant women in clinical trials and of international collaboration to improve the pharmacological treatment of pregnant women with COVID-19.

AIM: The objective of this study was to describe the use of COVID-19-related medicines during pregnancy and their evolution between the early/late periods of the pandemic. METHODS: Pregnant women who tested positive for SARS-CoV-2 from March 2020 to July 2021 were included using the COVI-PREG registry. Exposure to the following COVID-19-related medicines was recorded: antibiotics, antivirals, hydroxychloroquine, corticosteroids, anti-interleukin-6 and immunoglobulins. We described the prevalence of medicines used, by trimester of pregnancy, maternal COVID-19 severity level and early/late period of the pandemic (before and after 1 July 2020). FINDINGS: We included 1964 pregnant patients who tested positive for SARS-CoV-2. Overall, 10.4% (205/1964) received at least one COVID-19-related medicine including antibiotics (8.6%; 169/1694), corticosteroids (3.2%; 62/1964), antivirals (2.0%; 39/1964), hydroxychloroquine (1.4%; 27/1964) and anti-interleukin-6 (0.3%; 5/1964). The use of at least one COVID-19-related medicine was 3.1% (12/381) in asymptomatic individuals, 4.2% (52/1233) in outpatients, 19.7% (46/233) in inpatients without oxygen, 72.1% (44/61) in those requiring standard oxygen, 95.7% (22/23) in those requiring high flow oxygen, 96.2% (25/26) in patients who required intubation and 57.1% (4/7) among patients who died. The proportion who received medicines to treat COVID-19 was higher before than after July 2020 (16.7% vs. 7.7%). Antibiotics, antivirals and hydroxychloroquine had lower rates of use during the late period. CONCLUSION: Medicine use in pregnancy increased with disease severity. The trend towards increased use of corticosteroids seems to be aligned with changing guidelines. Evidence is still needed regarding the effectiveness and safety of COVID-19-related medicines in pregnancy.

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. &nbsp

Eimir Hurley & Sara Burke (Trinity College Dublin).-- Proyecto “Diseño de mecanismos de coordinación entre la política sanitaria y otros sectores de política pública para agilizar la respuesta a las crisis a partir del estudio de caso de las relaciones entre el sistema sanitario y la atención institucionalizada a mayores en contexto de pandemia en España y en Europa” (Mc-COVID19), financiado por el CSIC como Proyecto Intramural en el marco de la Plataforma Temática Interdisciplinar Salud Global.-- Los principales investigadores son Eloísa del Pino y Francisco Javier Moreno (CCHS-IPP, CSIC)., Financiado por el CSIC como Proyecto Intramural en el marco de la Plataforma Temática Interdisciplinar Salud Global.