Aim: To estimate the prevalence of medication use in non-hospitalized pregnant women with COVID-19 Methods: A prospective two-stage individual patient meta-analysis across 10 data sources in Europe and North America studied medication use among non-hospitalized pregnant women with COVID-19 between January 2020 to December 2022. Comparisons were made between medication use within 30 days pre- and post-COVID-19 diagnosis in this cohort and two comparator groups: pregnant women without COVID-19, and non-pregnant women with COVID-19. Prevalence estimates were pooled using a random-effects model stratified by trimester. Results: 50,335 non-hospitalized pregnant women with COVID-19 were identified. The pooled prevalence of antibacterial use in 3rd trimester was higher post-COVID-19 diagnosis (6.8%, 95%CI 5.5-8.4, I2=94%) compared with the same women pre-COVID-19 (3.9%, 95%CI 3.1-4.9, I2=89%). Overall, pregnant women with COVID-19 had higher medication use compared to pregnant women without COVID-19, although these differences were not statistically significant. Post-COVID-19, antithrombotics prevalence was 4.5% (95%CI 1.1-16.5, I2=100%) among pregnant women with COVID-19 in 3rd trimester, compared to 2.1% (95%CI 1.2-3.6, I2=99%) among those without COVID-19 in 3rd trimester. Compared to non-pregnant women with COVID-19, pregnant women with COVID-19 were less likely to be prescribed analgesics, antiprotozoals, corticosteroids, psychoanaleptics and psycholeptics, and more likely to be prescribed antithrombotics, cough and cold and nasal preparations across all trimesters. High heterogeneity existed in nearly all analyses. Conclusion: This international meta-analysis reveals low medication use and country-specific variations, enhancing insight into the management of COVID-19 in non-hospitalized pregnant women. Higher antithrombotics use post-COVID-19 suggests prophylactic treatment in this population.

OB, EM, EH, HMEN, AB, OS, PK, MUS, AC, JGL, EMJ, MEK, ST, WH, JJHM, LS, RG, OP, BPP, SJ, DT, CLRB, FSS, RL, MAB, EA, GF, AP, KP, CV, and SJS have no conflicts of interest to declare. CEC, DH, FA, KWMB, and MCJM report participation in research studies funded by pharmaceutical companies, with all funds paid to the institution where they are employed (no personal fees).

The research leading to the results for Covid-19 infectiOn aNd medicineS In preGnancy (CONSIGN) was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network, which is a public academic partnership coordinated by the Utrecht University (UU), The Netherlands. The project has received support from the European Medicines Agency (EMA) under the Framework service contract nr EMA/2018/28/PE and was scientifically coordinated by the University Medical Center Utrecht (UMCU). The content of this document expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties. Electronic healthcare data sources participating in the CONSIGN EHR study were partly funded by the EMA under the above-mentioned Framework service contract. Each of the other participating sites in this meta-analysis has its own funding to collect the data and generate the evidence. The Canadian Mother-Child (CAMCCO) Active Surveillance Initiative is a pan-Canadian program on drug safety and efficacy in pregnancy funded by the Canadian Institutes of Health Research (CIHR), and the Canada Foundation for Innovation (CFI), that is scientifically coordinated by CHU Sainte-Justine in Montreal, Quebec, Canada. The Sentinel System is a U.S. government initiative managed and funded by the U.S. Food and Drug Administration (FDA) and was scientifically coordinated by Harvard Pilgrim Health Care Institute. This publication reflects the views of the authors (JH, LS, WH) and should not be construed to represent FDA's views or policies.

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