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.

What Are Criteria for Considering Technologies' Uses and Influences in LMICs' Health Care Infrastructures?

A lack of health technology is an obstacle to health system growth in low- and middle-income countries (LMICs). US-based clinicians participating in global health efforts might sometimes wonder about clinical and ethical standards by which they should judge short- and long-term risks and benefits of bringing technological assistance with them to care for patients in LMICs. These countries are heterogeneous and changing, so establishing an evidence base for clinical and ethical decision making about technology use could be an important priority. This article suggests clinically and ethically relevant criteria according to which health technologies' use and influence can be evaluated.

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.

4D ultrasound imaging - ethically justifiable in India?

Four-dimensional (4D) ultrasound (real-time volume sonography), which has been used in the West since the last decade for the determination of gender as well as for bonding and entertainment of the parents, has become widely available in India in this decade. Here, I would like to discuss the ethical issues associated with 4D ultrasonography in India. These are self-referral, the use of the technology for non-medical indications, a higher possibility of the disclosure of the foetus' gender and safety concerns.

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.

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.

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 detection of congenital anomalies in 76,155 births in the cities of Bogotá and Cali, 2011-2012]. / Detección ecográfica de anomalías congénitas en 76.155 nacimientos en Bogotá y Cali, 2011-2012.

INTRODUCTION: Congenital anomalies affect 2 to 3% of live births in Colombia and they are currently the leading cause of death in children under 1 year of age in Bogotá, and the third cause of death in children under 1 year of age in Cali. Congenital anomalies are a major factor contributing to fetal and infant mortality and morbidity in the world. Some congenital anomalies can be detected by obstetric ultrasonography, thus helping to decide on the best way to manage them. OBJECTIVE: To determine the rate of detection of congenital anomalies by obstetric ultrasound and the false positive rate comparing infants born with birth defects in Bogota and Cali treated at health care facilities of different levels of complexity. MATERIALS AND METHODS: We monitored 76,155 births in the cities of Cali and Bogotá based on a case-control model following the methodology of the Latin American Collaborative Study of Congenital Malformations (ECLAMC) from January 2011 to December 2012. RESULTS: The rate of malformed infants was 2.08%. The detection rate of diagnosable congenital anomalies was 31.45% among cases that had information about prenatal care. This rate is lower than that reported in the literature. Most of the congenital anomalies detected were of the central nervous system and of the genitourinary system. CONCLUSIONS: The low detection rate highlights the need to improve the quality of ultrasound to have greater sensitivity for adequate prenatal diagnosis that will contribute to the reduction of morbidity and mortality and allow for better care of newborns with malformations.

Salgen de Cuba: Una Red de Informática Provincial para Servicios Genéticos a Mujeres Embarazadas y Recién nacidos / Cubas Salgen: A Provincial Informatics Network for Genetic Services to Pregnant Women and Newborns

The Sancti Spíritus Provincial Medical Genetics Network has been using the Salgen IT platform since 2009 for health care, administrative and research activities concerning pregnant mothers and newborns. The network uses the national Infomed backbone to provide real-time connection between community-based polyclinics in primary health care and the Provincial Medical Genetics Reference Center. The platform has records for 23,025 pregnant women and sequential clinical data on genetic risk assessment in early pregnancy, first trimester ultrasound, sickle cell anemia screening, alpha-fetoprotein levels, cytogenetic antenatal diagnosis, second trimester ultrasound, delivery and newborn characteristics, neonatal metabolic screening, and infant clinical assessment. The system makes health care results immediately available and provides health alerts to enable timely preventive care for pregnant women. It also provides guidelines for processes and practices, and streamlines administrative and monitoring activities through statistical reports. The database generates indicators for assessing fetal growth and applies international standards for antenatal ultrasound quality control. Salgen provides a new source of information for medical research and knowledge management, and its use in this case fulfills Cuba's criteria for an integrated health services network(AU)