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Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials.
LaCourse, Sylvia; John-Stewart, Grace; Adams Waldorf, Kristina M.
  • LaCourse S; Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.
  • John-Stewart G; Department of Global Health, University of Washington, Seattle, Washington, USA.
  • Adams Waldorf KM; Global Center for Integrated Health of Women, Adolescents and Children (Global WACh), University of Washington, Seattle, Washington, USA.
Clin Infect Dis ; 71(15): 879-881, 2020 07 28.
Article in English | MEDLINE | ID: covidwho-66421
ABSTRACT
Investigators are employing unprecedented innovation in the design of clinical trials to rapidly and rigorously assess potentially promising therapies for coronavirus disease 2019 (COVID-19); this is in stark contrast to the continued near-universal regressive practice of exclusion of pregnant and breastfeeding women from these trials. The few trials that allow their inclusion focus on postexposure prophylaxis or outpatient treatment of milder disease, limiting the options available to pregnant women with severe COVID-19 to compassionate use of remdesivir, or off-label drug use of hydroxychloroquine or other therapies. These restrictions were put in place despite experience with these drugs in pregnant women. In this Viewpoint, we call attention to the need and urgency to engage pregnant women in COVID-19 treatment trials now in order to develop data-driven recommendations regarding the risks and benefits of therapies in this unique but not uncommon population.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus Type of study: Prognostic study Limits: Female / Humans / Pregnancy Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2020 Document Type: Article Affiliation country: Cid

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus Type of study: Prognostic study Limits: Female / Humans / Pregnancy Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2020 Document Type: Article Affiliation country: Cid