Abstract:Background Family planning is an important consideration for women with multiple sclerosis (MS), who are often diagnosed during their reproductive years. Currently, limited data are available on pregnancy outcomes in patients exposed to interferon-beta (IFN-beta) before or during pregnancy. Here, we present the cumulative pregnancy exposure data and prevalence of pregnancy and infant outcomes in IFN-beta-exposed pregnant women with MS from the European IFN-beta Pregnancy Registry. Methods Using spontaneous and… Show more
“…Previous observational studies [9][10][11][12][13][14][15][16][17][18] and a large post-authorisation safety study (PASS) [19] in women with MS have reported no increase in the prevalence of adverse pregnancy outcomes after exposure to IFN-beta before or during pregnancy. Data from Finland, however, suggest that the prevalence of elective terminations for reasons other than foetal anomaly may be increased among pregnant women exposed to IFN-beta [19].…”
“…Previous observational studies [9][10][11][12][13][14][15][16][17][18] and a large post-authorisation safety study (PASS) [19] in women with MS have reported no increase in the prevalence of adverse pregnancy outcomes after exposure to IFN-beta before or during pregnancy. Data from Finland, however, suggest that the prevalence of elective terminations for reasons other than foetal anomaly may be increased among pregnant women exposed to IFN-beta [19].…”
“…A detailed description of the indicated use and pregnancy safety data are shown in the panel . 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 Studies evaluating the use of vitamins for treatment of COVID-19 were analysed as an additional subgroup. Pregnancy safety profiles of drugs under evaluation for COVID-19 Lopinavir–ritonavir Lopinavir–ritonavir is a US Food and Drug Administration (FDA) pregnancy category C medication 8 used for the treatment of HIV.…”
Section: Search and Review Of Clinical Trial Registriesmentioning
Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of nonbiological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavirritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated highdose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.
“…Regarding the study population, the LAC trials that were assessed tend to systematically exclude children, adolescents, and pregnant and lactating women ( 10 ). Lopinavir/ritonavir and hydroxychloroquine are already used by pregnant women with HIV-infection and malaria, respectively; remdesivir has been tested in pregnant women during the Ebola outbreak; and women with multiple sclerosis receive interferon beta while pregnant ( 11 , 12 , 13 ). Yet pregnant women are being excluded from trials testing interventions with these drugs.…”
A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.
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