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

. 2021 Oct 13;18(20):10717.

doi: 10.3390/ijerph182010717.

Elena Marbán-Castro

1
, Clara Pons-Duran

1

2
, Laura Garcia-Otero

1
, Haily Chen

1
, Luis Bernardo Herrera

1
, Maria Del Mar Gil

3

4
, Anna Goncé

5
, Elena Ferriols-Pérez

6
, Miguel Angel Rodriguez

7
, Pigeon bull

8
, Azucena Bardají

1

2

9
, Rachel Gonzalez

1

2

9
, Clara Menendez

1

2

9
, Cristina Enguita-Fernàndez

1

Affiliations

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Elena Marbán-Castro et al.

Int J Environ Res Public Health.


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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.

Keywords:

COVID-19; acceptability; clinical trial; healthcare professionals; perceptions; pregnancy.

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.

Figures


Figure 1

Pregnant women’s decision factors to participate in a clinical trial during pregnancy.

References

    1. van der Graaf R., van der Zande IS, den Ruijter HM, Oudijk MA, van Delden JJ, Rengerink KO, Groenwold RH Fair inclusion of pregnant women in clinical trials: An integrated scientific and ethical approach. trial. 2018;19:78. doi: 10.1186/s13063-017-2402-9. –

      DOI



      PMC

      PubMed

    1. Whitehead C.L., Walker S.P. Consider pregnancy in COVID-19 therapeutic drug and vaccine trials. Lancet. 2020;395:e92. doi: 10.1016/S0140-6736(20)31029-1.



      DOI



      PMC

      PubMed

    1. 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.



      DOI

      PubMed

    1. 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.



      DOI

      PubMed

    1. 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.



      DOI



      PMC

      PubMed

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