Bioethics of Translating Limited Evidence into Clinical Practice: Case Study of the Cerebroplacental Ratio.

Bioethics can help address the challenges of translating research into clinical practice in the twenty-first century. The cerebroplacental ratio in obstetrical ultrasound provides a case study of how bioethical principles can help advance practical approaches when evidence is limited. This can help clinicians use cerebroplacental ratio when additional risk factors are present in critical cases that warrant increased surveillance; disclose limited information appropriately; allocate resources; and weigh benefits against risks. Balancing the key ethical principles of respect for autonomy, beneficence, non-maleficence, and justice within this context illuminates how bioethics can assist health care providers as well as help set a research agenda. Such analyses are essential to improving clinical care, given the rapid pace at which medicine is evolving.

On the Epistemic Status of Prenatal Ultrasound: Are Ultrasound Scans Photographic Pictures?

Medical imaging is predominantly a visual field. In this context, prenatal ultrasound images assume intense social, ethical, and psychological significance by virtue of the subject they represent: the fetus. This feature, along with the sophistication introduced by three-dimensional (3D) ultrasound imaging that allows improved visualization of the fetus, has contributed to the common impression that prenatal ultrasound scans are like photographs of the fetus. In this article we discuss the consistency of such a comparison. First, we investigate the epistemic role of both analogic and digital photographic images as visual information-providing representations holding a high degree of objectivity. Second, we examine the structure and process of production of ultrasound scans and argue that a comparison between two-dimensional (2D) ultrasound and photography is justified. This is in contrast to 3D ultrasound images that, due to the intensive mathematical processing involved in their production, present some structural issues that obfuscate their ontological and epistemic status.

A much valued tool that also brings ethical dilemmas - a qualitative study of Norwegian midwives' experiences and views on the role of obstetric ultrasound.

BACKGROUND: Midwives are the main providers of routine antenatal care services including the routine ultrasound examination in Norway. The ultrasound examination can be perceived by expectant parents not only as a medical examination but also as a social event facilitating attachment to their fetus. This study explores Norwegian midwives' experiences and views on the role of ultrasound in clinical management of pregnancy. METHODS: A qualitative study design was applied. Twenty-four midwives who all performed obstetric ultrasound examinations were recruited for focus group discussions and individual interviews. Data collection took place in 2015 in five hospitals in two different regions of Norway. Data were analyzed using qualitative content analysis. RESULTS: Midwives described obstetric ultrasound examinations as very valuable although doing ultrasounds placed high demands on their operational and counselling skills. Increasing requests for ultrasound from pregnant women were mentioned. Advancements in ultrasound diagnosis were considered to have put the fetus in the position of a patient, and that pregnant women declining ultrasound could be viewed as irresponsible by some health professionals. Ethical concerns were raised regarding the possibility of pregnancy termination when fetal anomalies were detected. Fears were also expressed that prenatal diagnoses including those following ultrasound, might create a society where only 'perfect' children are valued. However, participants stressed that their intention in performing ultrasound was to optimize pregnancy outcome and thereby assist expectant couples and their unborn children. CONCLUSIONS: Midwives in Norwegian maternity care services describe obstetric ultrasound as very valuable, playing a central role in pregnancy management by optimizing pregnancy outcomes. Although high demands are placed on operators' technical skills and counseling, midwives described performing obstetric ultrasound as very satisfying work. However, midwives believed that expectant parents' approach to the ultrasound examination, both its medical value and the precious images obtained of the fetus, could put extra strain on the midwives performing ultrasounds. The potential of ultrasound to detect fetal anomalies and the possibility that this may lead to termination of pregnancy, seemed to create some ambivalent feelings in midwives towards its use.

Phenomenology of pregnancy and the ethics of abortion.

In this article I investigate the ways in which phenomenology could guide our views on the rights and/or wrongs of abortion. To my knowledge very few phenomenologists have directed their attention toward this issue, although quite a few have strived to better understand and articulate the strongly related themes of pregnancy and birth, most often in the context of feminist philosophy. After introducing the ethical and political contemporary debate concerning abortion, I introduce phenomenology in the context of medicine and the way phenomenologists have understood the human body to be lived and experienced by its owner. I then turn to the issue of pregnancy and discuss how the embryo or foetus could appear for us, particularly from the perspective of the pregnant woman, and what such showing up may mean from an ethical perspective. The way medical technology has changed the experience of pregnancy-for the pregnant woman as well as for the father and/or other close ones-is discussed, particularly the implementation of early obstetric ultra-sound screening and blood tests (NIPT) for Down's syndrome and other medical defects. I conclude the article by suggesting that phenomenology can help us to negotiate an upper time limit for legal abortion and, also, provide ways to determine what embryo-foetus defects to look for and in which cases these should be looked upon as good reasons for performing an abortion.

Effectiveness and cost-effectiveness of routine third trimester ultrasound screening for intrauterine growth restriction: study protocol of a nationwide stepped wedge cluster-randomized trial in The Netherlands (The IRIS Study).

BACKGROUND: Intrauterine growth retardation (IUGR) is a major risk factor for perinatal mortality and morbidity. Thus, there is a compelling need to introduce sensitive measures to detect IUGR fetuses. Routine third trimester ultrasonography is increasingly used to detect IUGR. However, we lack evidence for its clinical effectiveness and cost-effectiveness and information on ethical considerations of additional third trimester ultrasonography. This nationwide stepped wedge cluster-randomized trial examines the (cost-)effectiveness of routine third trimester ultrasonography in reducing severe adverse perinatal outcome through subsequent protocolized management. METHODS: For this trial, 15,000 women with a singleton pregnancy receiving care in 60 participating primary care midwifery practices will be included at 22 weeks of gestation. In the intervention (n = 7,500) and control group (n = 7,500) fetal growth will be monitored by serial fundal height assessments. All practices will start offering the control condition (ultrasonography based on medical indication). Every three months, 20 practices will be randomized to the intervention condition, i.e. apart from ultrasonography if indicated, two routine ultrasound examinations will be performed (at 28-30 weeks and 34-36 weeks). If IUGR is suspected, both groups will receive subsequent clinical management as described in the IRIS study protocol that will be developed before the start of the trial. The primary dichotomous clinical composite outcome is 'severe adverse perinatal outcome' up to 7 days after birth, including: perinatal death; Apgar score <4 at 5 minutes after birth; impaired consciousness; need for assisted ventilation for more than 24 h; asphyxia; septicemia; meningitis; bronchopulmonary dysplasia; intraventricular hemorrhage; cystic periventricular leukomalacia; neonatal seizures or necrotizing enterocolitis. For the economic evaluation, costs will be measured from a societal perspective. Quality of life will be measured using the EQ-5D-5 L to enable calculation of QALYs. Cost-effectiveness and cost-utility analyses will be performed. In a qualitative sub-study (using diary notes from 32 women for 9 months, at least 10 individual interviews and 2 focus group studies) we will explore ethical considerations of additional ultrasonography and how to deal with them. DISCUSSION: The results of this trial will assist healthcare providers and policymakers in making an evidence-based decision about whether or not introducing routine third trimester ultrasonography. TRIAL REGISTRATION: NTR4367 , 21 March 2014.

Moral implications of obstetric technologies for pregnancy and motherhood.

Drawing on sociological and anthropological studies, the aim of this article is to reconstruct how obstetric technologies contribute to a moral conception of pregnancy and motherhood, and to evaluate that conception from a normative point of view. Obstetrics and midwifery, so the assumption, are value-laden, value-producing and value-reproducing practices, values that shape the social perception of what it means to be a "good" pregnant woman and to be a "good" (future) mother. Activities in the medical field of reproduction contribute to "kinning", that is the making of particular social relationships marked by closeness and special moral obligations. Three technologies, which belong to standard procedures in prenatal care in postmodern societies, are presently investigated: (1) informed consent in prenatal care, (2) obstetric sonogram, and (3) birth plan. Their widespread application is supposed to serve the moral (and legal) goal of effecting patient autonomy (and patient right). A reconstruction of the actual moral implications of these technologies, however, reveals that this goal is missed in multiple ways. Informed consent situations are marked by involuntariness and blindness to social dimensions of decision-making; obstetric sonograms construct moral subjectivity and agency in a way that attribute inconsistent and unreasonable moral responsibilities to the pregnant woman; and birth plans obscure the need for a healthcare environment that reflects a shared-decision-making model, rather than a rational-choice-framework.

Two sides of the same coin--an interview study of Swedish obstetricians' experiences using ultrasound in pregnancy management.

BACKGROUND: The extended use of ultrasound that is seen in maternity care in most Western countries has not only affected obstetric care but also impacted on the conception of the fetus in relation to the pregnant woman. This situation has also raised concerns regarding the pregnant woman's reproductive freedom. The purpose of this study was to explore Swedish obstetricians' experiences and views on the role of obstetric ultrasound particularly in relation to clinical management of complicated pregnancy, and in relation to situations where the interests of maternal and fetal health conflict. METHODS: A qualitative study design was applied, and data were collected in 2013 through interviews with 11 obstetricians recruited from five different obstetric clinics in Sweden. Data were analysed using qualitative content analysis. RESULTS: The theme that emerged in the analysis 'Two sides of the same coin' depicts the view of obstetric ultrasound as a very important tool in obstetric care while it also was experienced as having given rise to new and challenging issues in the management of pregnancy. This theme was built on three categories: I. Ultrasound is essential and also demanding; II. A woman's health interest is prioritised in theory, but not always in practice; and III. Ultrasound is rewarding but may also cause unwarranted anxiety. CONCLUSIONS: The widespread use of ultrasound in obstetric care has entailed new challenges for clinicians due to enhanced possibilities to diagnose and treat fetal conditions, which in turn might conflict with the health interests of the pregnant woman. There is a need for further ethical discussions regarding the obstetrician's position in management of situations where maternal and fetal health interests conflict. The continuing advances in the potential of ultrasound to impact on pregnancy management will also increase the need for adequate and appropriate information and counselling. Together with other health care professionals, obstetricians therefore need to develop improved ways of enabling pregnant women and their partners to make informed decisions regarding pregnancy management.

Fetal ultrasound examination and assessment of genetic soft markers in Sweden: are ethical principles respected?

OBJECTIVE: To explore procedures for providing information, assessment and documentation about ultrasound soft markers in Sweden. DESIGN: Descriptive, quantitative, cross-sectional survey. SAMPLE: Eighty-two percent of all obstetric ultrasound clinics in Sweden (covering >90% of routine fetal ultrasound examinations). METHODS: Postal questionnaire survey between December 2010 and January 2011. MAIN OUTCOME MEASURES: Items about provision of information, risk estimation, and follow-up strategies in relation to observed ultrasound soft markers. RESULTS: More than 96% of all fetal routine ultrasound examinations were performed at 15-21 gestational weeks, primarily by midwives. Half of the clinics replying wanted prospective parents to be provided with information, but 38 (78%) of the clinics did not routinely inform about assessment of soft markers before the examination. Follow up and decisions on whether to give information when soft markers were found were based on the number and type of the observed markers, whether other structural deviations existed, and on the woman's age and anxiety level. Only at eight clinics (17%) were parents informed about all soft marker findings. At 13 clinics (28%) observed markers were documented/recorded, even though the women were not informed. CONCLUSIONS: Information regarding the assessment and importance of observed soft markers seems to be inconsistent and insufficient. Provision of information and documentation of findings appear to be handled differently at obstetric ultrasound clinics. This suggests that Swedish ethical principles relating to healthcare and ultrasound examinations are incompletely followed and national guidelines appear to be necessary.

Prenatal screening: current practice, new developments, ethical challenges.

Prenatal screening pathways, as nowadays offered in most Western countries consist of similar tests. First, a risk-assessment test for major aneuploides is offered to pregnant women. In case of an increased risk, invasive diagnostic tests, entailing a miscarriage risk, are offered. For decades, only conventional karyotyping was used for final diagnosis. Moreover, several foetal ultrasound scans are offered to detect major congenital anomalies, but the same scans also provide relevant information for optimal support of the pregnancy and the delivery. Recent developments in prenatal screening include the application of microarrays that allow for identifying a much broader range of abnomalities than karyotyping, and non-invasive prenatal testing (NIPT) that enables reducing the number of invasive tests for aneuploidies considerably. In the future, broad NIPT may become possible and affordable. This article will briefly address the ethical issues raised by these technological developments. First, a safe NIPT may lead to routinisation and as such challenge the central issue of informed consent and the aim of prenatal screening: to offer opportunity for autonomous reproductive choice. Widening the scope of prenatal screening also raises the question to what extent 'reproductive autonomy' is meant to expand. Finally, if the same test is used for two different aims, namely detection of foetal anomalies and pregnancy-related problems, non-directive counselling can no longer be taken as a standard. Our broad outline of the ethical issues is meant as an introduction into the more detailed ethical discussions about prenatal screening in the other articles of this special issue.

Ultrasound's 'window on the womb' brings ethical challenges for balancing maternal and fetal health interests: obstetricians' experiences in Australia.

BACKGROUND: Obstetric ultrasound has become a significant tool in obstetric practice, however, it has been argued that its increasing use may have adverse implications for women's reproductive freedom. This study aimed to explore Australian obstetricians' experiences and views of the use of obstetric ultrasound both in relation to clinical management of complicated pregnancy, and in situations where maternal and fetal health interests conflict. METHODS: A qualitative study was undertaken as part of the CROss-Country Ultrasound Study (CROCUS). Interviews were held in November 2012 with 14 obstetricians working in obstetric care in Victoria, Australia. Data were analysed using qualitative content analysis. RESULTS: One overall theme emerged from the analyses: The ethical challenge of balancing maternal and fetal health interests, built on four categories: First, Encountering maternal altruism' described how pregnant women's often 'altruistic' position in relation to the health and wellbeing of the fetus could create ethical challenges in obstetric management, particularly with an increasing imbalance between fetal benefits and maternal harms. Second, 'Facing shifting attitudes due to visualisation and medico-technical advances' illuminated views that ultrasound and other advances in care have contributed to a shift in what weight to give maternal versus fetal welfare, with increasing attention directed to the fetus. Third, 'Guiding expectant parents in decision-making' described the difficult task of facilitating informed decision-making in situations where maternal and fetal health interests were not aligned, or in situations characterised by uncertainty. Fourth, 'Separating private from professional views' illuminated divergent views on when the fetus can be regarded as a person. The narratives indicated that the fetus acquired more consideration in decision-making the further the gestation progressed. However, there was universal agreement that obstetricians could never act on fetal grounds without the pregnant woman's consent. CONCLUSIONS: This study suggests that medico-technical advances such as ultrasound have set the scene for increasing ethical dilemmas in obstetric practice. The obstetricians interviewed had experienced a shift in previously accepted views about what weight to give maternal versus fetal welfare. As fetal diagnostics and treatment continue to advance, how best to protect pregnant women's right to autonomy requires careful consideration and further investigation.

Medical students' attitudes towards conscientious objection: a survey.

OBJECTIVE: To examine medical students' views on conscientious objection and controversial medical procedures. METHODS: Questionnaire study among Norwegian 5th and 6th year medical students. RESULTS: Five hundred and thirty-one of 893 students (59%) responded. Respondents object to a range of procedures not limited to abortion (up to 19%)-notably euthanasia (62%), ritual circumcision for boys (52%), assisted reproduction for same-sex couples (9.7%) and ultrasound in the setting of prenatal diagnosis (5.0%). A small minority (4.9%) would object to referrals for abortion. In the case of abortion, up to 55% would tolerate conscientious refusals, whereas 42% would not. Higher proportions would tolerate refusals for euthanasia (89%) or ritual circumcision for boys (72%). DISCUSSION: A majority of Norwegian medical students would object to participation in euthanasia or ritual circumcision for boys. However, in most settings, many medical students think doctors should not be able to refuse participation on grounds of conscience. A minority would accept conscientious refusals for procedures they themselves do not object to personally. Most students would not accept conscientious refusals for referrals. CONCLUSIONS: Conscientious objection remains a live issue in the context of several medical procedures not limited to abortion. Although most would want a right to object to participation in euthanasia, tolerance towards conscientious objectors in general was moderate or low.

Ethical issues arising from the INTERGROWTH-21st Fetal Growth Longitudinal Study.

The INTERGROWTH-21st Project presented a complex set of ethical challenges given the involvement of health institutions in geographically and culturally diverse areas of the world, with differing attitudes to pregnancy. This paper addresses how the research team dealt with some of those issues.

Towards a new procreation ethic: the exemplary instance of cleft lip and palate.

The improvement of ultrasound scan techniques is enabling ever earlier prenatal diagnosis of developmental anomalies. In France, apart from cases where the mother's life is endangered, the detection of "particularly serious" conditions, and conditions that are "incurable at the time of diagnosis" are the only instances in which a therapeutic abortion can be performed, this applying up to the 9th month of pregnancy. Thus numerous conditions, despite the fact that they cause distress or pain or are socially disabling, do not qualify for therapeutic abortion, despite sometimes pressing demands from parents aware of the difficulties in store for their child and themselves, in a society that is not very favourable towards the integration and self-fulfilment of people with a disability. Cleft lip and palate (CLP), although it can be completely treated, is one of the conditions that considerably complicates the lives of child and parents. Nevertheless, the recent scope for making very early diagnosis of CLP, before the deadline for legal voluntary abortion, has not led to any wave of abortions. CLP in France has the benefit of a exceptional care plan, targeting both the health and the integration of the individuals affected. This article sets out, via the emblematic instance of CLP, to show how present fears of an emerging "domestic" or liberal eugenic trend could become redundant if disability is addressed politically and medically, so that individuals with a disability have the same social rights as any other citizen.

'Normal' nuchal translucency: a justification to refrain from detailed scan? Analysis of 6858 cases with special reference to ethical aspects.

OBJECTIVE: To assess the prevalence and detection rate of major anomalies (MAs) by applying first trimester anomaly scan (FTAS) including first trimester fetal echocardiography (FTFE) to all fetuses and discuss ethical implications. METHODS: The study group included 6879 consecutive fetuses with known outcome of pregnancy (follow-up: 98%), 6565 with 'normal' nuchal translucency (NT) (≤ P95), 314 with 'increased' NT (> P95). All fetuses received FTAS/FTFE. As MAs with the potential of being detected at FTAS/FTFE, we defined anomalies present at conception or developed during first trimester. RESULTS: Prevalence of MAs in fetuses with 'normal' NT reached 1.7%. Although 29.8% of chromosomal abnormalities were found in the group of 'normal' NT, 77% of MAs accompanied by a normal karyotype were found in this group. In fetuses with 'normal' NT and MA, diagnosis was made prenatally in 87.4% (FTAS/FTFE: 58.6%). CONCLUSION: A relevant number of MA is present in fetuses with 'normal' NT. More than half will be detected by FTAS/FTFE. As consequence, one should discuss a concept in which also in fetuses with 'normal' NT, FTAS/FTFE should be offered. This concept can also be justified from an ethical point of view, which focuses on the principles of nonmaleficence, justice and respect for autonomy of the pregnant woman.

Autonomous abortions: the inhibiting of women's autonomy through legal ultrasound requirements.

Recently, we have seen various proposed laws that would require that women considering abortions be given ultrasounds along with explanations of these ultrasounds. Proponents of these laws could argue that they are assisting with autonomous abortion choices by providing needed information, especially about the ontological status of the fetus. Arguing against these proposed laws, I first claim that their supporters fail to appreciate how personalized an abortion choice must be. Second, I argue that these laws would provide the pregnant woman no control over when and to what extent emotion is inserted into her deliberation. This unjustly inhibits her autonomy, making these ultrasound laws unjustified.

Ethical challenges in fetal surgery.

Fetal surgery has been practised for some decades now. However, it remains a highly complex area, both medically and ethically. This paper shows how the routine use of ultrasound has been a catalyst for fetal surgery, in creating new needs and new incentives for intervention. Some of the needs met by fetal surgery are those of parents and clinicians who experience stress while waiting for the birth of a fetus with known anomalies. The paper suggests that the role of technology and visualisation techniques in creating and meeting such new needs is ethically problematic. It then addresses the idea that fetal surgery should be restricted to interventions that are life-saving for the fetus, arguing that this restriction is unduly paternalistic. Fetal surgery poses challenges for an autonomy-based system of ethics. However, it is risky to circumvent these challenges by restricting the choices open to pregnant women, even when these choices appear excessively altruistic.