Recent efforts to develop reliable and efficient early pregnancy screening programmes for pre-eclampsia have focused on combining clinical, biochemical and biophysical markers. The same model has been used for first-trimester screening for fetal aneuploidies i.e. prenatal diagnosis (PD), which is routinely offered to all pregnant women in many developed countries. Some studies suggest combining PD and pre-eclampsia screening, so women can be offered testing for a number of conditions at the same clinical visit. A combination of these tests may be practical in terms of saving time and resources; however, the combination raises ethical issues. First-trimester PD and pre-eclampsia screening entail qualitative differences which alter the requirements for disclosure, non-directedness and consent with regard to the informed consent process. This article explores the differences related to the ethical issues raised by PD and pre-eclampsia in order to elucidate which factors are relevant to deciding the type of information and consent required in each context from the perspective of the ethical principles of beneficence and autonomy. Furthermore, it argues that ensuring respect for patient autonomy is context dependent and, consequently, pre-eclampsia screening and PD should be performed independently of one another.
Pre-eclampsia is a complication of pregnancy that threatens the health of both mother and baby. It has recently been discovered that aspirin is an effective treatment of pre-eclampsia, but only if the mother starts taking aspirin before the 12th week of pregnancy. Presently, much research into the development of a method of screening for pre-eclampsia, similar to that currently used to detect Down’s syndrome during pregnancy, is underway. Some studies have suggested combining the Down’s syndrome and pre-eclampsia screening tests during the first trimester of pregnancy. There are good reasons for this as the time frame for testing is the same and some of the same components can be used in both tests. However, in this paper, we analyse the types of risk and benefits associated with both tests and we find that the type of information required for patients to give consent, and the type of consent required (written, verbal or implicit), are not the same. We find it problematic to combine these tests, and we recommend performing each test independently of the other.
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.
2015, Best Practice and Research: Clinical Obstetrics and Gynaecology
Citation 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].
A number of groups are currently examining the potential of screening for pre-eclampsia and gestational diabetes at 12 weeks' gestation. This can be performed at the time of combined first-trimester screening for aneuploidy using a similar method of regression analysis to combine multiple demographic and investigative factors. At present, research into the prediction of pre-eclampsia is more robust and is associated with the potential for therapeutic intervention that can reduce the prevalence of early-onset pre-eclampsia and improve maternal and neonatal outcomes.
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.
