About: Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries

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An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries
Creator	Adesomo, Adebayo Costantine, Maged Landon, Mark Pippen, Jessica Rood, Kara »more»
source	Medline; PMC
abstract	Objective Pregnant women have been historically excluded from clinical trials for nonobstetric conditions, even during prior epidemics. The objective of this review is to describe the current state of research for pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. Study Design We conducted a search of international trial registries for trials relating to the novel coronavirus. The eligibility criteria for each trial were reviewed for inclusion/exclusion of pregnant women. Relevant data were extracted and descriptive statistics were calculated for individual and combined data. The total number of trials from each registry were compared, as well as the proportions of pregnancy-related trials within each. Results Among 621,370 trials in the World Health Organization International Clinical Trials Registry, 927 (0.15%) were COVID-19 related. Of those, the majority (52%) explicitly excluded pregnancy or failed to address pregnancy at all (46%) and only 16 (1.7%) were pregnancy specific. When categorized by region, 688 (74.2%) of COVID-19 trials were in Asia, followed by 128 (13.8%) in Europe, and 66 (7.2%) in North America. Of the COVID-19 trials which included pregnant women, only three were randomized-controlled drug trials. Conclusion Approximately 1.7% of current COVID-19 research is pregnancy related and the majority of trials either explicitly exclude or fail to address pregnancy. Only three interventional trials worldwide involved pregnant women. The knowledge gap concerning the safety and efficacy of interventions for COVID-19 created by the exclusion of pregnant women may ultimately harm them. While “ethical” concerns about fetal exposure are often cited, it is in fact unethical to habitually exclude pregnant women from research. Key Points: Pregnancy was excluded from past pandemic research. Pregnancy is being excluded from COVID-19 research. Exclusion of pregnant women is potentially harmful.
has issue date	2020-05-19(xsd:dateTime)
bibo:doi	10.1055/s-0040-1712103
bibo:pmid	32428965
has license	no-cc
sha1sum (hex)	004d8e5957da5dce42a9c6b85b48c2b261820498
schema:url	https://doi.org/10.1055/s-0040-1712103
resource representing a document's title	Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries
has PubMed Central identifier	PMC7356075
has PubMed identifier	32428965
schema:publication	Am J Perinatol
resource representing a document's body	covid:004d8e5957da5dce42a9c6b85b48c2b261820498#body_text
is schema:about of	named entity 'The knowledge' named entity 'gap' named entity 'proportions' named entity 'descriptive statistics' named entity 'coronavirus' »more»

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