ArticleIncluding ethical considerations in models for first-trimester screening for pre-eclampsia
Introduction
Pre-eclampsia is a hypertensive condition which contributes significantly to maternal and perinatal morbidity and mortality (Sibai et al., 2005). Recent studies have demonstrated the benefits of treating high-risk pregnancies with low-dose aspirin if administered prior to week 16 (Bujold et al., 2010). The effectiveness of such a treatment is thus dependent on the development of a screening test that can predict those pregnancies which are at risk prior to week 16.
Demographic and clinical factors known to be associated with the development of pre-eclampsia, such as nulliparity, ethnicity, diabetes, hypertension and obesity, have low predictive values with regard to detecting pregnancies that will develop pre-eclampsia (Poon et al., 2010). Screening for pre-eclampsia is not a new phenomenon, but technological progress and acquired knowledge regarding the pathophysiology has advanced, providing new methods of preventing and treating the disease (Jorgensen et al., 2012). Consequently, many studies have focused on the utility of various biochemical markers in qualifying the prediction of later onset (Akolekar et al., 2011, Cuckle, 2011, Hedley et al., 2010, Poon et al., 2009). Among these studies, a trend has emerged in which the pre-eclampsia screening is combined with first-trimester screening for fetal chromosomal abnormalities i.e. prenatal diagnosis (PD), a test routinely offered to women in many developed countries. However, the ethical issues associated with combined first-trimester pre-eclampsia screening and PD have yet to be investigated.
This paper seeks to pinpoint variables of both a technical and ethical character relevant to deciding an appropriate framework for implementing a screening test for pre-eclampsia with improved discriminatory power, especially focusing on the possible ethical issues related to combined PD and pre-eclampsia screening when seen through the perspective of the ethical principles of beneficence and autonomy. This paper begins by discussing how ethical issues related to the concept of informed consent apply to each type of screening independently, as it is expected that requirements for informed consent are context dependent. If there is reason to believe that requirements of the informed consent procedure vary widely between each screening context, then offering combined first-trimester screening may be problematic.
Section snippets
Protecting and promoting public health and the health of individuals
Public health goals are set with the aim of promoting good health within distinct populations. To realize these goals, new structures and treatments are often implemented into health care, which determines to some extent the framework for clinical practice. At an individual level, the clinical approach based on broad public health goals may have unexpected negative consequences (Childress and Bernheim, 2008). Therefore, when evaluating public health goals and establishing the framework under
Practicality of combined first-trimester PD and pre-eclampsia screening
In working towards ensuring that women are offered optimum health care during pregnancy, the National Institute for Health and Clinical Excellence (NCCWCH, 2008, NICE, 2010) in the UK issued specific guidelines recommending that women be screened for pre-eclampsia at their first prenatal visit, which currently includes demographic information combined with blood pressure measurements and urine analysis for proteins (NCCWCH, 2008, NICE, 2010). However, as mentioned previously, demographic and
Ethical analysis
Most women contact their healthcare provider when they become pregnant; the challenge from a medical point of view is to ensure good health throughout pregnancy. The physician is in general expected to provide care based on the moral principles of beneficence, which asserts an obligation to confer benefit through a balance of benefit and harm, and autonomy, which asserts an obligation to respect the choices of the pregnant woman within the context of standard prenatal care (Beauchamp and
Qualitative differences between pre-eclampsia screening and PD
The scope of a public health goal and associated interventions may conflict more or less with general moral considerations. In such cases, public health goals may be limited, constrained or promoted. Conflicts can be reduced by implementing a requirement for informed consent, either written or verbal (Childress and Bernheim, 2008). Tristram Engelhardt states that the amount of disclosure and consent required in a specific context depends on the extent to which the healthcare professional and
Conclusion
An improved screening test to detect the risk of developing pre-eclampsia early in gestation that is combined with the already existing test for fetal abnormalities may be technically and economically feasible; nevertheless, it is an ethically problematic model. Such a combined test creates conflict between the obligation to respect the autonomy of the pregnant woman and the beneficence-based obligation towards the fetus. Combining PD and pre-eclampsia screening may lead to a desensitization
Acknowledgements
The authors wish to thank the Danish Strategic Research Fund for financial support.
References (43)
- et al.
Ethics in fetal medicine
Baillieres Best Pract. Res. Clin. Obstet. Gynaecol.
(1999) Screening for pre-eclampsia – lessons from aneuploidy screening
Placenta
(2011)- et al.
Evidence-based health policy: context and utilisation
Soc. Sci. Med.
(2004) The global impact of pre-eclampsia and eclampsia
Semin. Perinatol.
(2009)- et al.
Posttraumatic stress disorder after pre-eclampsia: an exploratory study
Gen. Hosp. Psychiatry
(2002) - et al.
Cardiovascular health after maternal placental syndromes (champs): population-based retrospective cohort study
Lancet
(2005) - et al.
Ethical issues relating to reproduction control and women’s health
Int. J. Gynaecol. Obstet.
(1997) - et al.
Pre-eclampsia
Lancet
(2005) Acog committee opinion #321: maternal decision making, ethics, and the law
Obstet. Gynecol.
(2005)- et al.
Prediction of early, intermediate and late pre-eclampsia from maternal factors, biophysical and biochemical markers at 11–13 weeks
Prenat. Diagn.
(2011)
Principles of Biomedical Ethics
Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis
Obstet. Gynecol.
The professional responsibility model of obstetrical ethics: avoiding the perils of clashing rights
Am. J. Obstet. Gynecol.
Public health ethics. Public justification and public trust
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
Screening for down’s syndrome in early and late first and second trimester using six maternal serum markers
Clin. Genet.
Human placental lactogen is a first-trimester maternal serum marker of down syndrome
Prenat. Diagn.
Personalised risk communication for informed decision making about taking screening tests
Cochrane Database Syst. Rev
The Foundations of Bioethics
Maternal plasma soluble endoglin at 11–13 weeks’ gestation in pre-eclampsia
Ultrasound Obstet. Gynecol.
New concepts in screening
Br. J. Gen. Pract.
Cited by (9)
The first trimester: Prediction and prevention of the great obstetrical syndromes
2015, Best Practice and Research: Clinical Obstetrics and GynaecologyCitation Excerpt :Similarly, it is important to recognize that no screening algorithm has been described for women with multiple pregnancies. Whilst incorporation of PET screening into the combined first-trimester test presents some difficulties for counselling, expedience dictates this is both the most appropriate gestational point and cost-effective approach for screening [39]. There is no evidence that women defined as being at high risk for ePET have higher levels of anxiety later in their pregnancy [40].
The ʼnormalization’ of prenatal screening: Prevention as prenatal beneficence
2018, The Fetus as a Patient: A Contested Concept and its Normative ImplicationsThe fetus as a patient: A sustainable approach for clinical interactions in the field of new prenatal medicine?
2018, The Fetus as a Patient: A Contested Concept and its Normative ImplicationsImperfect Pregnancies: A History of Birth Defects and Prenatal Diagnosis
2017, Imperfect Pregnancies: A History of Birth Defects and Prenatal DiagnosisNon-invasive prenatal testing for fetal chromosome abnormalities: Review of clinical and ethical issues
2016, Application of Clinical GeneticsNon-invasive prenatal testing for aneuploidy and beyond: Challenges of responsible innovation in prenatal screening
2015, European Journal of Human Genetics
Paula Hedley is the head of the genetics laboratory in the Section of Molecular Medicine, Department of Clinical Biochemistry, Immunology and Genetics, Statens Serum Institut, Copenhagen, Denmark. She is a medical biologist with over 10 years’ experience in experimental design, clinical translation and communication of results. Her principal research foci are molecular cardiology and adipocytokine dysregulation in reproductive disorders.