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Balancing risks: making decisions for maternal treatment without data on fetal safety - 30/04/21

Doi : 10.1016/j.ajog.2021.01.025 
Howard Minkoff, MD a, b, , Jeffrey Ecker, MD c
a Department of Obstetrics and Gynecology, Maimonides Medical Center, Brooklyn, NY 
b Department of Obstetrics and Gynecology, School of Public Health, SUNY Downstate Health Sciences University Brooklyn, NY 
c Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA 

Corresponding author: Howard Minkoff, MD.

Abstract

Challenges arise when treatment to improve maternal health brings the possibility of risk to fetal health. The coronavirus disease 2019 (COVID-19) vaccine is the most recent, but hardly the only, example. Because pregnant patients are often specifically excluded from trials of new therapies, this is often the dilemma that patients and providers face when considering new treatments. In this study, we used the COVID-19 vaccine as an exemplar to question the broader issue of how society, in general, and obstetricians, in particular, should balance obligations to pregnant women’s right of access to new therapeutic agents with the physician’s desire to protect the fetus from potential risks. We will argue that in almost all circumstances (with few exceptions, as will also be discussed), maternal benefit and respect for autonomy create the uncertainty that absent safety data bring. Consequently, if pregnant women choose to try new interventions and treatments, such as the COVID-19 vaccination, they should be offered those new regimens and their decision supported. In addition, we will argue that the right solution to avoid the dilemma of absent data is to include pregnant individuals in clinical trials studying new treatments, drugs, and other therapies. We will also discuss the basis for our opinion, which are mainstream obstetrical ethics, precedents in law (supreme court ruling that forbids companies to exclude women from jobs that might pose a risk to the fetus), and historic events (thalidomide). The ethical framework includes the supposition that sacrifice to improve fetal outcome is a virtue and not a mandate. Denying a pregnant patient treatment because of threats to their life can create absurd and paradoxical consequences. Either requiring abortion or premature delivery before proceeding with treatments to optimize maternal health, or risking a patient’s own life and ability to parent a child by delaying treatment brings clear and significant risks to fetal and/or neonatal outcomes. With rare exceptions, properly and ethically balancing such consequential actions cannot be undertaken without considering the values and goals of the pregnant patient. Therefore, active participation of both the pregnant patient and their physician in shared decision making is needed.

Le texte complet de cet article est disponible en PDF.

Key words : coronavirus disease 2019 vaccine, coronavirus disease 2019, discrimination, Food and Drug Administration, fetal beneficence, fetal risks, maternal autonomy, maternal choice, medication in pregnancy, pregnancy, thalidomide


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 The authors report no conflict of interest.
 The authors report no funding for this work.


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Vol 224 - N° 5

P. 479-483 - mai 2021 Retour au numéro
Article précédent Article précédent
  • Professionally responsible coronavirus disease 2019 vaccination counseling of obstetrical and gynecologic patients
  • Frank A. Chervenak, Laurence B. McCullough, Eran Bornstein, Lisa Johnson, Adi Katz, Renee McLeod-Sordjan, Michael Nimaroff, Burton L. Rochelson, Asma Tekbali, Ashley Warman, Kim Williams, Amos Grünebaum
| Article suivant Article suivant
  • The coronavirus disease 2019 vaccine in pregnancy: risks, benefits, and recommendations
  • Irene A. Stafford, Jacqueline G. Parchem, Baha M. Sibai

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