Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

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Editorial - (2020)

Ethical Issues for Pregnant Women with Influenza Randomized Clinical Trials

Martin C*
*Correspondence: Martin C, Department of Clinical Trials Transformation Initiative, Duke University, USA, Email:

Author info »


According to numerous studies, pregnant women are considered to be at higher risk of severe illness from seasonal and pandemic influenza. Therefore, WHO, American Centers for Disease Control and Prevention of Disease (CDC), European Centre for the Control and Prevention Diseases (ECDC), European Commission, Health Security Committee (HSC) [1]. Significant obstetric history was defined as having at least one of the following events: late miscarriage (between 14th and 21th+6 days weeks of gestation), preterm delivery (between 22th and 36th+6 days weeks of gestation), and history of pre-eclampsia/gestational hypertension, intrauterine growth restriction, fetal malformation
or fetal death [2].

These surprising results were according to previous studies that have established this same lack of serious relationship between healthcare workers status and better level of seasonal influenza vaccination. Furthermore, pregnant women at high risk of exposition and likewise disease-spreading should are more vaccinated. However, women working with the public/ with children, and people with children living reception, weren't more vaccinated than women at low risk of exposition and disease-spreading.

The Ethical Complexity of Rcts in Pregnancy

Even where opportunity to participate in randomized clinical trials (RCTs) is offered, there are challenges in recruiting pregnant women as participants in RCTs [3].

Many women assessed for eligibility may not be recruited in the research, yet high assessed-but-not-recruited rates affect the feasibility [4]. External validity of conducting obstetric the sole significant determinant related to non-vaccination was the occupation: working pregnant women being more vaccinated than pregnant housewives [5].


In conclusion, during a large prospective study conducted in pregnant women during the 2009 H1N1 influenza pandemic, the vaccination coverage against A/H1N1 influenza was low (62.9% of non-vaccinated women), particularly in immigrant women and people having a coffee socio-economic status.


  1. Siston AM, Rasmussen SA, Honein MA, Fry AM, Seib K, Callaghan WM, et al. Pandemic 2009 influenza a(H1N1) virus illness among pregnant women in the United States. JAMA. 2010;303(15):1517
  2. Creanga AA, Johnson TF, Graitcer SB, Hartman LK, Al-Samarrai T, Schwarz AG, et al. Severity of 2009 pandemic influenza a (H1N1) virus infection in pregnant women. Obstet Gynecol. 2010;115(4):717
  3. Chaves SS, Lynfield R, Lindegren ML, Bresee J, Finelli L. The US influenza hospitalization surveillance network. Emerg Infect Dis. 2015;21(9):1543
  4. Huang WT, Hsu YF, Kuo TW, Wu WJ, Chuang JH. Complicated pandemic (H1N1) 2009 during pregnancy, Taiwan. Emerg Infect Dis. 2011;17(10):1958

Author Info

Martin C*
Department of Clinical Trials Transformation Initiative, Duke University, USA

Citation: Martin C (2020) Ethical Issues for Pregnant Women with Influenza Randomized Clinical Trials. J Clin Trials. S4:e001

Received: 26-Oct-2020 Accepted: 11-Nov-2020 Published: 19-Nov-2020 , DOI: 10.35248/2167-0870.20.S4.e001

Copyright: © 2020 Martin C. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.