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

Author

Listed:
  • Elena Marbán-Castro

    (ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain)

  • Clara Pons-Duran

    (ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain
    Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), 28029 Madrid, Spain)

  • Laura García-Otero

    (ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain)

  • Haily Chen

    (ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain)

  • Luis Bernardo Herrera

    (ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain)

  • María del Mar Gil

    (Obstetrics and Gynecology Department, Hospital Universitario de Torrejón, Torrejón de Ardoz, 28850 Madrid, Spain
    School of Medicine, Universidad Francisco de Vitoria, 28223 Madrid, Spain)

  • Anna Goncé

    (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)

  • Elena Ferriols-Pérez

    (Department Gynaecology and Obstetrics, Parc de Salut Mar University Hospital, 08003 Barcelona, Spain)

  • Miguel Ángel Rodríguez

    (HM Puerta del Sur, Móstoles, 28938 Madrid, Spain)

  • Paloma Toro

    (Obstetrics and Gynecology Department, Complejo Asistencial de Segovia, Hospital General de Segovia, 40002 Segovia, Spain)

  • Azucena Bardají

    (ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain
    Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), 28029 Madrid, Spain
    Centro de Investigação em Saúde de Manhiça (CISM), Maputo 1929, Mozambique)

  • Raquel González

    (ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain
    Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), 28029 Madrid, Spain
    Centro de Investigação em Saúde de Manhiça (CISM), Maputo 1929, Mozambique)

  • Clara Menéndez

    (ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain
    Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), 28029 Madrid, Spain
    Centro de Investigação em Saúde de Manhiça (CISM), Maputo 1929, Mozambique)

  • Cristina Enguita-Fernàndez

    (ISGlobal, Hospital Clínic-Universitat de Barcelona, 08036 Barcelona, Spain)

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.

Suggested Citation

  • Elena Marbán-Castro & Clara Pons-Duran & Laura García-Otero & Haily Chen & Luis Bernardo Herrera & María del Mar Gil & Anna Goncé & Elena Ferriols-Pérez & Miguel Ángel Rodríguez & Paloma Toro & Azucen, 2021. "Acceptability of Clinical Trials on COVID-19 during Pregnancy among Pregnant Women and Healthcare Providers: A Qualitative Study," IJERPH, MDPI, vol. 18(20), pages 1-14, October.
    • Handle: RePEc:gam:jijerp:v:18:y:2021:i:20:p:10717-:d:654914
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    References listed on IDEAS

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    1. Strömmer, Sofia & Lawrence, Wendy & Rose, Taylor & Vogel, Christina & Watson, Daniella & Bottell, Joanne N. & Parmenter, Janice & Harvey, Nicholas C. & Cooper, Cyrus & Inskip, Hazel & Baird, Janis & B, 2018. "Improving recruitment to clinical trials during pregnancy: A mixed methods investigation," Social Science & Medicine, Elsevier, vol. 200(C), pages 73-82.
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