Ethical issues in the management of pregnancies complicated by fetal anomalies.
ABSTRACT Ethics is an essential dimension of the clinical management of pregnancies complicated by fetal anomalies. Utilizing the ethical principles of beneficence and respect for autonomy, this review first sets out the ethical concept of the fetus as a patient. This concept provides the basis for a comprehensive approach to ethical issues in the management of pregnancies complicated by fetal anomalies. Practical, ethically justified guidance is given for the physician's role in counseling pregnant women about aggressive management, termination of pregnancy, selective termination of multifetal pregnancies, nonaggressive management, cephalocentesis, and fetal research.
- SourceAvailable from: Colleen M Gallagher[show abstract] [hide abstract]
ABSTRACT: The call for the inclusion of pregnant women in clinical trials has received renewed attention recently. This interest springs from articles in various medical journals highlighting the gaps in medical knowledge and the need to improve health care for pregnant women.It is not a simple decision whether to include pregnant women in studies or not. The general thought is that it's too dangerous for the baby if a pregnant woman is participating in a trial, and the absence of research on how medications work in pregnant women leave doctors guessing about how to safely and effectively treat patients through pregnancy.Excluding pregnant women from clinical trials are not automatic, not unethical nor is it arbitrarily determined. The regulatory framework is based on sound ethical and legal reasoning that demonstrates when inclusion in a clinical trial is appropriate or when clear and compelling reasons for exclusion are presented. LEARNING OBJECTIVE: Readers will learn about limitations of research, history of the inclusion and exclusion of pregnant women in clinical trials, reticence for inclusions, as well as regulations designed using reasoned legal and ethical principles, such as: Principle of Autonomy, Informed Consent, and Beneficence and Nonmaleficence.Journal of clinical research & bioethics. 03/2011; 2(108).
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ABSTRACT: Molecular karyotyping using chromosome microarray analysis (CMA) detects more pathogenic chromosomal anomalies than classical karyotyping, making CMA likely to become a first tier test for prenatal diagnosis. Detecting copy number variants of uncertain clinical significance raises ethical considerations. We consider the risk of harm to a woman or her fetus following the detection of a copy number variant of uncertain significance, whether it is ethically justifiable to withhold any test result information from a woman, what constitutes an 'informed choice' when women are offered CMA in pregnancy and whether clinicians are morally responsible for 'unnecessary' termination of pregnancy. Although we are cognisant of the distress associated with uncertain prenatal results, we argue in favour of the autonomy of women and their right to information from genome-wide CMA in order to make informed choices about their pregnancies. We propose that information material to a woman's decision-making process, including uncertain information, should not be withheld, and that it would be paternalistic for clinicians to try to take responsibility for women's decisions to terminate pregnancies. Non-directive pre-test and post-test genetic counselling is central to the delivery of these ethical objectives.Prenatal Diagnosis 04/2012; 32(4):389-95. · 2.68 Impact Factor
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ABSTRACT: To determine how severe were the conditions leading to termination of pregnancy for foetal anomaly (TOPFA) in France. Detailed indications for TOPFA were extracted from medical charts. Of 2465 completed records, indications were: chromosomal anomalies n = 963 (39.1%), malformations of a single organ without chromosomal or genetic aetiologies n = 898 (36.4%), multiple malformations without chromosomal or genetic aetiologies n = 238 (9.7%), obstetrical complications n = 161 (6.5%), non-chromosomal genetic diseases n = 158 (6.4%), foetal infections n = 21 (0.9%), unexplained severe oligohydramnios n = 20 (0.8%), foetal exposure to teratogenic agents n = 6. Overall, 33.3% of anomalies were lethal (e.g. anencephaly), 25.2% were expected to result in isolated mental retardation (e.g. Down) and 35.1% in substantial handicap (e.g. myelomeningocele). In 6.4% of cases, the anomaly was either of late onset (e.g. Huntington's disease) or with uncertain prognosis (e.g. agenesis of corpus callosum) or severity was debatable (e.g. single limb agenesis, sickle cell disease). Although there is no indisputable definition of which anomalies are 'severe', 93.6% of the decisions to terminate the pregnancy were made by women and professionals in reaction to anomalies which clearly were lethal or would lead to substantial physical and/or mental disabilities.Prenatal Diagnosis 06/2010; 30(6):531-9. · 2.68 Impact Factor