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doi: 10.3390/ijerph182010717.
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Affiliations
- 1 ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain.
- 2 Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), 28029 Madrid, Spain.
- 3 Obstetrics and Gynecology Department, Torrejón University Hospital, Torrejón de Ardoz, 28850 Madrid, Spain.
- 4 School of Medicine, Universidad Francisco de Vitoria, 28223 Madrid, Spain.
- 5 Fetal Medicine Research Center, BCNatal-Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu) and Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036 Barcelona, Spain.
- 6 Department Gynaecology and Obstetrics, Parc de Salut Mar University Hospital, 08003 Barcelona, Spain.
- 7 HM Puerta del Sur, Móstoles, 28938 Madrid, Spain.
- 8 Obstetrics and Gynecology Department, Complejo Asistencial de Segovia, Hospital General de Segovia, 40002 Segovia, Spain.
- 9 Manhiça Health Research Center (CISM), Maputo 1929, Mozambique.
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Elena Marbán-Castro et al.
Int J Environ Res Public Health.
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doi: 10.3390/ijerph182010717.
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- 1 ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain.
- 2 Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), 28029 Madrid, Spain.
- 3 Obstetrics and Gynecology Department, Torrejón University Hospital, Torrejón de Ardoz, 28850 Madrid, Spain.
- 4 School of Medicine, Universidad Francisco de Vitoria, 28223 Madrid, Spain.
- 5 Fetal Medicine Research Center, BCNatal-Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu) and Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036 Barcelona, Spain.
- 6 Department Gynaecology and Obstetrics, Parc de Salut Mar University Hospital, 08003 Barcelona, Spain.
- 7 HM Puerta del Sur, Móstoles, 28938 Madrid, Spain.
- 8 Obstetrics and Gynecology Department, Complejo Asistencial de Segovia, Hospital General de Segovia, 40002 Segovia, Spain.
- 9 Manhiça Health Research Center (CISM), Maputo 1929, Mozambique.
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Abstract
Participation of pregnant women in clinical trials entails challenges mainly related to concerns about the risks for fetuses. We undertook a qualitative study from June to October 2020 to assess the acceptability of participating in COVID-19 clinical trials among pregnant women in Spain. Phenomenology and grounded theory were used as methodological approaches. Semi-structured interviews were conducted with 24 pregnant women and six healthcare providers. Women were unsure if pregnancy was a risk factor to acquire the infection or to develop severe disease and expressed the limited information they had received, which led to uncertainties and emotional suffering. They had concerns regarding participation in clinical trials on COVID-19, regardless of the drug under study. Healthcare providers alluded to the importance of involving pregnant women’s relatives at the recruitment visit of the clinical trial. These findings may be useful to facilitate pregnant women’s participation in clinical trials.
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Keywords:
COVID-19; acceptability; clinical trial; healthcare professionals; perceptions; pregnancy.
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Conflict of interest statement
The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.
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Figures
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Pregnant women’s decision factors to…
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Figure 1
Pregnant women’s decision factors to participate in a clinical trial during pregnancy.
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– Figure 1 Pregnant women’s decision factors to participate in a clinical trial during pregnancy.
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References
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Payne P. Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards. Ethic Hum. Res. 2019;41:35–40. doi: 10.1002/eahr.500036.
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Heyrana K., Byers H.M., Stratton P. Increasing the Participation of Pregnant Women in Clinical Trials. JAMA. 2018;320:2077–2078. doi: 10.1001/jama.2018.17716.
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Bischof E., Oertelt-Prigione S., Morgan R., Klein S.L., The Sex and Gender in COVID19 Clinical Trials Working Group (SGC) Gender and COVID19 Working Group Towards Precision Medicine: Inclusion of Sex and Gender Aspects in COVID-19 Clinical Studies—Acting Now before It Is Too Late—A Joint Call for Action. Int. J. Environ. Res. Public Health. 2020;17:3715. doi: 10.3390/ijerph17103715.
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