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Article

Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study

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ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain
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Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), 28029 Madrid, Spain
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Obstetrics and Gynecology Department, Hospital Universitario de Torrejón, Torrejón de Ardoz, 28850 Madrid, Spain
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School of Medicine, Universidad Francisco de Vitoria, 28223 Madrid, Spain
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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
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Department Gynaecology and Obstetrics, Parc de Salut Mar University Hospital, 08003 Barcelona, Spain
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HM Puerta del Sur, Móstoles, 28938 Madrid, Spain
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Obstetrics and Gynecology Department, Complejo Asistencial de Segovia, Hospital General de Segovia, 40002 Segovia, Spain
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Centro de Investigação em Saúde de Manhiça (CISM), Maputo 1929, Mozambique
*
Author to whom correspondence should be addressed.
Academic Editors: Jangwoon Park, Jungyoon Kim and Jaehyun Park
Int. J. Environ. Res. Public Health 2021, 18(20), 10717; https://doi.org/10.3390/ijerph182010717 (registering DOI)
Received: 2 September 2021 / Revised: 1 October 2021 / Accepted: 8 October 2021 / Published: 13 October 2021
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. View Full-Text
Keywords: COVID-19; pregnancy; acceptability; clinical trial; perceptions; healthcare professionals COVID-19; pregnancy; acceptability; clinical trial; perceptions; healthcare professionals
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MDPI and ACS Style

Marbán-Castro, E.; Pons-Duran, C.; García-Otero, L.; Chen, H.; Herrera, L.B.; Gil, M.d.M.; Goncé, A.; Ferriols-Pérez, E.; Rodríguez, M.Á.; Toro, P.; Bardají, A.; González, R.; Menéndez, C.; Enguita-Fernàndez, C. Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study. Int. J. Environ. Res. Public Health 2021, 18, 10717. https://doi.org/10.3390/ijerph182010717

AMA Style

Marbán-Castro E, Pons-Duran C, García-Otero L, Chen H, Herrera LB, Gil MdM, Goncé A, Ferriols-Pérez E, Rodríguez MÁ, Toro P, Bardají A, González R, Menéndez C, Enguita-Fernàndez C. Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study. International Journal of Environmental Research and Public Health. 2021; 18(20):10717. https://doi.org/10.3390/ijerph182010717

Chicago/Turabian Style

Marbán-Castro, Elena, Clara Pons-Duran, Laura García-Otero, Haily Chen, Luis B. Herrera, María d.M. Gil, Anna Goncé, Elena Ferriols-Pérez, Miguel Á. Rodríguez, Paloma Toro, Azucena Bardají, Raquel González, Clara Menéndez, and Cristina Enguita-Fernàndez. 2021. "Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study" International Journal of Environmental Research and Public Health 18, no. 20: 10717. https://doi.org/10.3390/ijerph182010717

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