A decade of advocacy for the inclusion of pregnant women in the clinical research agenda is starting to pay off. In September, the United States Task Force on Research Specific to Pregnant Women and Lactating Women issued its advice to the secretary of Health and Human Services on addressing gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. The task force is pushing for major (...) reforms. If its recommendations are taken up, we can anticipate a significant shift in pregnancy research in the United States. This will affect pregnant women, clinicians caring for them, researchers, and institutional review boards. (shrink)

Reasoning well about risk is most challenging when a woman is pregnant, for patient and doctor alike. During pregnancy, we tend to note the risks of medical interventions without adequately noting those of failing to intervene, yet when it's time to give birth, interventions are seldom questioned, even when they don't work. Meanwhile, outside the clinic, advice given to pregnant women on how to stay healthy in everyday life can seem capricious and overly cautious. This kind (...) of reasoning reflects fear, not evidence. (shrink)

Courts and legislatures are increasingly being called upon to restrict the autonomy of pregnant women by requiring them to behave in ways that others determine are best for the fetuses they carry. The state should not attempt to transform pregnant women into ideal baby‐making machines. Pregnant women make decisions about their behavior in the context of the rest of their lives, with all the attendant complexities and pressures. Our interest in helping future children by (...) improving prenatal care would best be furthered by helping pregnant women to make informed, less constrained choices, not by punishing women or depriving them of choices altogether. (shrink)

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy (...) underlying risk-benefit decisions in clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that (...) class='Hi'>women have been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

Smajdor and Rasanen (2024) argue that pregnant women are routinely denied appropriate treatment because pregnancy is seen as normal, and so they are denied ‘patient status’. They claim that formally classifying pregnancy as a disease may lead to better treatment for pregnant women. In this response, we argue that pathologising pregnancy and classifying all pregnant women as ‘diseased patients’ won’t reconfigure care in ways that benefit all women. Rather, it will likely only embolden (...) the view that clinicians are entitled to exercise jurisdiction over pregnant women and beget the increased use of medical intervention where it is not necessarily needed. (shrink)

Discussion of the behaviour of pregnant women and mothers, in academic literature, medical advice given to mothers, mainstream media and social media, assumes that a mother who fails to do something to benefit her child is liable for moral criticism unless she can provide sufficient countervailing considerations to justify her decision. I reconstruct the normally implicit reasoning that leads to this assumption and show that it is mistaken. First, I show that the discussion assumes that if any (...) action might benefit her child, the mother has a defeasible duty to perform that action. I suggest that this assumption is implicitly supported by two arguments but that each argument is unsound. The first argument conflates moral reasons and defeasible duties; the second misunderstands the scope of a defeasible duty to benefit. This argument has important practical and theoretical implications: practically, it provides a response to a highly damaging discourse on maternal behaviour; theoretically, it provides the framework for a clearer understanding of the scope and nature of defeasible duties to benefit. (shrink)

Maternal–fetal surgery (MFS) encompasses a range of innovative procedures aiming to treat fetal illnesses and anomalies during pregnancy. Their development and gradual introduction into healthcare raise important ethical issues concerning respect for pregnant women’s bodily integrity and autonomy. This paper asks what kind of ethical framework should be employed to best regulate the practice of MFS without eroding the hard-won rights of pregnant women. I examine some existing models conceptualising the relationship between a pregnant woman (...) and the fetus to determine what kind of framework is the most adequate for MFS, and conclude that an ecosystem or maternal–fetal dyad model is best suited for upholding women’s autonomy. However, I suggest that an appropriate framework needs to incorporate some notion of fetal patienthood, albeit a very limited one, in order to be consistent with the views of healthcare providers and their pregnant patients. I argue that such an ethical framework is both theoretically sound and fundamentally respectful of women’s autonomy, and is thus best suited to protect women from coercion or undue paternalism when deciding whether to undergo MFS. (shrink)

The publication of the latest contribution to the alcohol-in-pregnancy debate, and the now customary flurry of media attention it generated, have precipitated the renewal of a series of ongoing debates about safe levels of consumption and responsible prenatal conduct. The University College London (UCL) study’s finding that low levels of alcohol did not contribute to adverse behavioural outcomes—and may indeed have made a positive contribution in some cases—is unlikely to be the last word on the subject. Proving a negative correlation (...) is notoriously difficult (technically, impossible), and other studies have offered alternative claims. The author is not an epidemiologist, and the purpose of this article is not to evaluate the competing empirical claims. However, the question of what information and advice healthcare practitioners ought to present to pregnant women, or prospectively or potentially pregnant women, in a situation of uncertainty is one to which healthcare ethicists may have a contribution to make. In this article, it is argued that the total abstinence policy advocated by the UK’s Department of Health, and even more stridently by the British Medical Association, sits uneasily with recent data and is far from ethically unproblematic. In particular, the “precautionary” approach advocated by these bodies displays both scant regard for the autonomy of pregnant and prospectively pregnant women and a confused grasp of the principles of beneficence and non-maleficence. (shrink)

In this article the results of a study of psychological readiness of pregnant women to parenthood are presented. Psychological readiness is defined as a structure consisting of three components: the cognitive, emotional, and behavioral, which is consistent with the single theory of psychological processes L. M. Vekkera. It was found that the main component that determines the high level of psychological readiness for motherhood is a cognitive component. The content of the cognitive component includes an understanding of the (...) child as a value. Some results of the research of value orientations of pregnant women in the structure of psychological readiness for parenthood. To identify the value system of pregnant women, the method of ‘Value Orientations‘ by M. Rokich was applied. The analysis of empirical data was performed using factor analysis and U criterion of Mann-Whitney. Respondents were distributed into two age groups: first group of 21-25 years, second group of 26-30 years. All women are nulliparous. The younger age group of pregnant women is characterized by values that are directed at the outside world. Emotional component dominates in the structure of psychological readiness for motherhood. Values of women in the second group are aimed at children. Cognitive and behavioral components dominate in the structure of their psychological readiness for motherhood. Knowledge of the structure of psychological readiness of women to parenthood will help to diagnose disorders of maternal behavior, to design methods of its correction and prevention. (shrink)

South Africa has an abortion law which codifies the broad themes of reproductive rights set out in the Constitution of South Africa, other laws and national guidelines. Certain wording of the conditions in the Choice Act for abortion after 20 weeks' gestation, are open to interpretation, being ‘severe malformation of the fetus’ and ‘risk of injury to the fetus’. From 24 weeks onwards, abortion is carried out by feticide/induced fetal cardiac asystole (‘IFCA’) and subsequent induction of labour in South Africa. (...) Some maternal‐fetal units have developed guidelines to assist clinicians and patients in decision‐making around eligibility for abortion after 20 weeks' gestation, given the broad terms in the law. We consider the guideline used by an institution in the Western Cape for abortion after 23 weeks and 6 days gestation, in terms of its alignment with the law on reproductive rights and its compliance with fair and transparent procedures. We also note its effect on respect for patients and on staff professionalism. (shrink)

The introduction of non-invasive prenatal testing in healthcare systems around the world offers an opportunity to reconsider funding policies for prenatal screening. In some countries with universal access healthcare systems, pregnant women and their partners are asked to pay for NIPT. In this paper, we discuss two important rationales for charging women for NIPT: to prevent increased uptake of NIPT and to promote informed choice. First, given the aim of prenatal screening, high or low uptake rates are (...) not intrinsically desirable or undesirable. Using funding policies to negatively affect uptake, however, is at odds with the aim of screening. Furthermore, copayment disproportionally affects those of lower socioeconomic status, which conflicts with justice requirements and impedes equal access to prenatal screening. Second, we argue that although payment models may influence pregnant women’s choice behaviours and perceptions of the relevance of NIPT, the copayment requirement does not necessarily lead to better-informed choices. On the contrary, external influences on women’s personal choices for or against prenatal screening should ideally be avoided. To improve informed decision-making, healthcare systems should instead invest in adequate non-directive, value-focused pretest counselling. This paper concludes that requiring copayments for NIPT in universal access healthcare systems fails to promote reproductive autonomy and is unfair. (shrink)

A new study published in Journal of Medical Ethics by van der Zande et al 1 further highlights why classifying pregnant women as a ‘vulnerable population’ in the context of research is deeply problematic. Because the designation of ‘vulnerable’ is otherwise applied to populations whose decision-making capacity about research participation is somehow compromised—such as children and adults of limited cognitive ability—many of us have been arguing for some time that using this designation for pregnant women is (...) inappropriate and disrespectful.2–4 There is nothing about the state of pregnancy that renders pregnant women incapable of offering valid research consents or refusals. Moreover, rather than protecting the health interests of pregnant women and their offspring, this designation has had the opposite effect. It has contributed to the widespread exclusion of pregnant women from research activities, which is itself pernicious to the health of pregnant women.5 We know that pregnant women encounter a range of health needs across their pregnancies. In the USA, for example, approximately 9 out of every 10 women use some kind of medication during pregnancy to manage health conditions.6 Yet because pregnant women have largely been …. (shrink)

This book discusses 'how' to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons 'why' the inclusion of pregnant women in clinical research is necessary - viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift (...) to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials. (shrink)

Smoking is frequently presented as being particularly problematic when the smoker is a pregnant woman because of the potential harm to the future child. This premise is used to justify targeting pregnant women with a unique approach to smoking cessation including policies such as the routine testing of all pregnant women for carbon monoxide at every antenatal appointment. This paper examines the evidence that such policies are justified by the aim of harm prevention and argues (...) that targeting pregnant women in this way is likely to do more harm than good. Routine carbon monoxide testing is particularly problematic as it sends a message to pregnant women that they cannot be trusted either to truthfully answer questions as to whether or not they smoke, or to make decisions in the best interests of themselves and their future children in the way that non-pregnant individuals are. Further, if the aim is to reduce rates of prenatal harm, the evidence suggests that adopting a supportive and empowering approach to prenatal care is the most effective way to achieve this, something that the current policies aimed at pregnant women are in conflict with. (shrink)

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such (...) as those on fair inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

Abstract:This article analyzes the pervasive practice in US carceral institutions of shackling incarcerated pregnant women during childbirth and postpartum. After a review of bioethical, civil, and human rights norms, which widely condemn the practice, I advance an interpretation of the social meaning of shackling imprisoned pregnant women and its persistence despite widespread normative consensus in favor of its abolition. Two arguments regarding the persistence of the practice are considered: (1) that it stems from the unthinking exportation (...) of prison rules to a hospital setting and (2) that it is the product of an androcentric approach to punishment and carceral health care ill-adapted to women’s needs. I argue that these explanatory frameworks are inattentive to the intersecting genealogies of race and gender that are constitutive of the practice. As a result, the prescriptive horizons that these frameworks delineate are inadequate to the race- and gender-specific task of redress. Drawing from Black feminist theory and Nietzsche, I argue that the practice of shackling imprisoned pregnant women, like many ostensibly race-neutral facets of American mass incarceration, is a sedimentation of slavery that impacts all incarcerated women. The practice is symptomatic of the persistent anti-Blackness of the criminal legal system and the unfinished project of American abolition. (shrink)

Background Noninvasive prenatal testing (NIPT) provides important benefits yet raises ethical concerns. We surveyed Canadian pregnant women and their partners to explore their views regarding pressure to test and terminate a pregnancy, as well as other societal impacts that may result from the routinization of NIPT.Methods A questionnaire was offered (March 2015 to July 2016) to pregnant women and their partners at five healthcare facilities in four Canadian provinces.Results 882 pregnant women and 395 partners (...) completed the survey. 64% of women anticipated feeling no pressure to take the test if it were offered routinely, and 39% were not concerned about routinization leading to increased pressure to terminate a pregnancy of a fetus with Down Syndrome. Regarding other social concerns possibly resulting from routinization, pregnant women were most concerned regarding a reduction in resources available for people with Down Syndrome and their families and least concerned regarding a decrease in the population of people with Down Syndrome.Conclusions Our findings reflect the concerns expressed by pregnant women and their partners, both personal (pressure to test, pressure to terminate) and societal (e.g., regarding potential negative impact on people with disabilities and their families). Even if most women were not concerned about feeling pressured to test due to NIPT routinization, a large minority express concerns that should not be taken lightly. Moreover, a majority of respondents were concerned regarding pressure to terminate pregnancies due to NIPT routinization as well as regarding most societal impacts they were queried on, especially the possible future reduction in resources available for people with DS and their families. Canadian policy-makers should consider these potential negative ramifications of NIPT and ensure that appropriate social policies accompany its implementation. (shrink)

Despite the attempts to promote the inclusion of pregnant women into clinical research, this group is still widely excluded. An analysis of the “vulnerability of pregnant women” that questions deeply internalized stereotypes is necessary for finding the right balance in the protection of pregnant women as research participants. Criticism of the traditional account of vulnerability will lead to an alternative that focuses on situations rather than groups and on the obligations of responsible parties. The (...) paper adds to the current general discussion of vulnerability and at the same time addresses the specific problem of drug treatment during pregnancy. (shrink)

Robinson argues that by certain threshold criteria, pregnant women qualify for a higher moral status by reason of their pregnancies. While her intention is to make this a status upgrade for women, we worry that it may result in a status downgrade for women as a class, by presupposing and reinforcing women’s value in relation to their reproductive labour. Historically, central to feminist analysis is resistance to reductive accounts of women in relation to their (...) reproductivity. For example, de Beauvoir addressed men’s transcendence and contrasted it with women’s immanence, a status distinction possible because women are mired in expectations that they will marry, produce children and remain in the domestic realm; and for her part, Firestone argued that biological reproduction underlies women’s inferiority to men and that ‘The reproduction of the species by one sex for the benefit of both (should) be replaced by…artificial reproduction’1 2 Her concern was to liberate women from expectations of biological reproduction so their productive value in society is not reduced to their reproductive contributions. A formidable body of analysis in this same vein cautions against collapsing the value of women into their pregnancies, so much so that some commentators even distinguish ‘mothering’ from gestation.3 Robinson’s argument that pregnant women qualify at a higher threshold of personhood emphasises …. (shrink)

Purpose: The purposes of this study were to investigate the relationship between dental anxiety amongst pregnant women and their dental attendance patterns, considering various sociodemographic factors, at health centers in the Kingdom of Saudi Arabia. Materials and Methods: Participants in this cross-sectional descriptive study were 386 pregnant women seeking care at Saudi Ministry of Health centers. A validated version of the Modified Dental Anxiety Scale (MDAS) was used to measure dental anxiety. Questionnaires including background data and (...) dental anxiety were used and clinical data were collected. The association between oral health literacy and dental anxiety was evaluated with Spearman’s correlation coefficient. A multiple linear regression model with dental anxiety (MDAS score) as the dependent variable was developed to investigate further the relationship dental anxiety amongst pregnant women and their dental attendance patterns. Results: The prevalence of dental anxiety was very anxious (3.595). According to a multiple binary logistic regression model, previous experiences with dentists, household income, educational level, number of times and months of pregnancy, and the perception that oral care should be avoided during pregnancy were independently associated with dental anxiety. Conclusions: Dental anxiety in pregnant women is linked to social and psychological factors, in addition to oral health. Specifically, prior experiences with dentists, attitudes toward dental care, and general fear appear to have the strongest influence on dental anxiety. The prevalence of dental anxiety was high among this sample of pregnant women. The study shows that dental care providers need to pay attention to providing a supportive dental care situation, where patients should not experience pain. There is a need to understand the psychological factors associated with dental care procedures. (shrink)

In research involving pregnant women and fetuses, a number of questions arise concerning the balancing of risks and benefits. In research that holds out a prospect of direct benefit for the woman, how much risk to the fetus is permissible? How should the principle of minimizing risks be applied when there are two subjects—pregnant woman and fetus? Should risks for each of them be minimized? What if minimizing risks for one increases risks for the other? These and (...) other questions are not addressed in the current federal regulations for the protection of human subjects. This paper reviews the current regulations, attempts to identify issues that need to be addressed, considers alternative viewpoints concerning those issues, and argues for particular views. It concludes with a set of proposed guidelines for balancing risks and benefits in research involving pregnant women and fetuses. (shrink)

There is longstanding consensus on the need to include pregnant women in research. The goal of clinical research is to find highly regulated, carefully controlled, morally responsible ways to generate evidence...

There is increasing global pressure to ensure that pregnant women are responsibly and safely included in clinical research in order to improve the evidence base that underpins healthcare delivery during pregnancy. One supposed barrier to inclusion is the assumption that pregnant women will be reluctant to participate in research. There is however very little empirical research investigating the views of pregnant women. Their perspective on the benefits, burdens and risks of research is a crucial (...) component to ensuring effective recruitment. The Research In Pregnancy Ethics study set out to ascertain the views of pregnant women about research participation using an inductive thematic analysis. We conducted semi-structured interviews with 20 women who had participated in a double-blind randomised placebo controlled trial in Wellington while pregnant. Our results show that at least some pregnant women recognise the value and importance of research during pregnancy. The women we interviewed were deeply invested in the research process and outcomes. Key motivations for participating were altruism, playing a valuable civic role and the importance of research. The main perceived burdens related to inconvenience and time commitment. For some women, possible randomization to the placebo arm was regarded as a burden or disadvantage. (shrink)

Recourse to a being’s moral status is the ‘nuclear option’ of moral theorising—it tells us not only what obligations we have and to what degree, but whether we have obligations to them in the first place and whether their moral concern trumps concern for other beings simply in virtue of the kind of being they are. As such, we should only explain obligations in terms of a being’s moral status if doing so is principled and necessary to defend that obligation. (...) In ‘Pregnancy and Superior Moral Status: A Proposal for Two Thresholds of Personhood’, Robinson1 argues that pregnant women achieve a second and therefore superior threshold of moral status to ‘mere persons’. She insists that this is not a view about the woman and the fetus together but that ‘the pregnant woman herself is more than one individual’. This gives us strong reason to re-balance the imbalanced burdens experienced by women due to pregnancy. I will argue her proposal is neither principled nor necessary. We can explain special obligations to pregnant women without appealing to a distinct moral status, without reaching for the ‘nuclear option’. First, consider Robinson’s1 claim that pregnant women ‘are performing a role which is of supreme importance: that of creating new human life, and maintaining the survival of the human species’. …. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence (...) of the increased numbers of women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

Pregnant women and their interests have been underrepresented in health research. Little is known about issues relevant to women considering research participation during pregnancy. We performed in-depth interviews with 22 women enrolled in either one of two trials sponsored by the National Institutes of Health to assess the safety and immunogenicity of the H1N1 vaccine during pregnancy. Three themes characterized women’s decisions to participate in research: they valued early access to the vaccine, they perceived a (...) safety advantage when participating in research, and they wanted to help advance scientific knowledge. However, there were also some considerations that would disincline them to participate in research—for instance, a significant risk of maternal or fetal harm, the presence of a placebo arm in a study, or a requirement to significantly change planned therapy or behavior. Pregnant women who participated in the H1N1 vaccine trials viewed research favorably, citing its advantages over standard clinical care. These findings emphasize that access to benefit should guide policy for including pregnant women in research. (shrink)

U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services’ regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than (...) has previously been reflected in the literature. It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions. (shrink)

ObjectivePregnancy leads to long-lasting changes in brain structure for healthy women; however, little is known regarding alterations in the cortical features of pregnant women with malformed fetuses. Isolated clefts of the lip and/or palate (ICL/P) are the most common congenital anomaly in the craniofacial region, which is highly gene-associated. We speculated that pregnant women carrying fetuses with ICL/P may have associated risk genes and specific brain changes during pregnancy.MethodsIn this study, we investigated T1-weighted brain magnetic (...) resonance imaging data from 48 pregnant women: 24 women carrying fetuses with ICL/P (ICL/P group) and 24 women carrying normal fetuses (normal controls), then explored intergroup differences in gray matter volume (GMV), cortical thickness (CT) and cortical complexity (gyrification).ResultsCompared with controls, the ICL/P group had decreased total intracranial volume (TIV) than normal controls; besides, they exhibited increased GMV in the left cuneus, decreased GMV in the right superior temporal gyrus; increased CT in the left precuneus and left superior parietal gyrus, decreased CT involving parsopercularis, fusiform, middle temporal in the left hemisphere and supramarginal, precentral gyrus (PreCG) in the right hemisphere; increased gyrification in the left insula and PreCG, the left middle temporal, and the right supratemporal gyrus.ConclusionPregnant women with ICL/P fetuses had brain morphology changes involving language, auditory, vision, and sensory cortex, which may be their special brain changes compared to normal pregnant women. This study may provide clues for the early detection of fetuses with ICL/P, and be vital for preconception and prenatal counseling with non-invasive methods. (shrink)

Since the introduction of drugs to prevent vertical transmission of HIV, the purpose of and approach to HIV testing of pregnant women has increasingly become an area of major controversy. In recent years, many strategies to increase the uptake of HIV testing have focused on offering HIV tests to women in pregnancy-related services. New global guidance issued by the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) specifically notes these services as an (...) entry point for provider-initiated HIV testing and counseling (PITC). The guidance constitutes a useful first step towards a framework within which PITC sensitive to health, human rights and ethical concerns can be provided to pregnant women in health facilities. However, a number of issues will require further attention as implementation moves forward. It is incumbent on all those involved in the scale up of PITC to ensure that it promotes long-term connection with relevant health services and does not result simply in increased testing with no concrete benefits being accrued by the women being tested. Within health services, this will require significant attention to informed consent, pre- and post-test counseling, patient confidentiality, referrals and access to appropriate services, as well as reduction of stigma and discrimination. Beyond health services, efforts will be needed to address larger societal, legal, policy and contextual issues. The health and human rights of pregnant women must be a primary consideration in how HIV testing is implemented; they can benefit greatly from PITC but only if it is carried out appropriately. (shrink)

To address the burden of maternal morbidity and mortality in low‐ and middle‐income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC‐context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle‐income setting. This qualitative research used (...) participant observation, in‐depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision‐making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context‐specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner. (shrink)

In the UK, it has been proposed that alongside the current advice to abstain from alcohol completely in pregnancy, there should be increased screening of pregnant women for alcohol consumption in order to prevent instances of fetal alcohol spectrum disorder. The Scottish Intercollegiate Guidelines Network published guidelines in 2019 recommending that standardised screening questionnaires and associated use of biomarkers should be considered to identify alcohol exposure in pregnancy. This was followed in 2020 by the National Institute for (...) Health and Care Excellence Draft Quality Standard, which recommended that pregnant women should have information on their alcohol consumption recorded throughout their pregnancy and this information transferred to the child’s health records. Most recently, Public Health England has stated that the alcohol intake of all women should be recorded throughout pregnancy, not just at the initial booking appointment and that tools such as blood biomarkers and meconium testing should be researched in order to determine true prevalence rates of alcohol in pregnancy. We argue that this proposed enhanced screening undermines women’s autonomy and their legal right to be sufficiently informed to consent to screening. We argue that there is no evidence that this kind of screening will result in a reduction of fetal harm and there is a danger that undermining the autonomy of women and the trust relationship between women and healthcare professionals may even increase harm to future children. (shrink)

This study appeared in full in the last issue of Research Ethics Review (2007; 3(1): 18). Rowena Jones is an obstetrician working in a busy hospital for women. Her research focuses on changes in women's brains during pregnancy1. Rowena plans to use magnetic resonance imaging to record images of the brains of women in the second and third trimesters and after birth at 6 and 24 weeks. Her sample consists of two groups of healthy women with (...) uncomplicated and singleton pregnancies, the first primigravid and the second multiparous. There will be a minimum of five and a maximum of ten women in each group. (shrink)

Recent global advances in available technology to prevent mother-to-child HIV transmission necessitate a rethinking of contemporary and previous ethical debates on HIV testing as a means to preventing vertical transmission. In this paper, we will provide an ethical analysis of HIV-testing strategies of pregnant women. First, we argue that provider-initiated opt-out HIV testing seems to be the most effective HIV test strategy. The flip-side of an opt-out strategy is that it may end up as involuntary testing in a (...) clinical setting. We analyse this ethical puzzle from a novel perspective, taking into account the moral importance of certain hypothetical preferences of the child, as well as the moral importance of certain actual preferences of the mother. Finally, we balance the conflicting concerns and try to arrive at an ethically sound solution to this dilemma. Our aim is to introduce a novel perspective from which to analyse testing strategies, and to explore the implications and possible benefits of our proposal. The conclusion from our analysis is that policies that recommend provider-initiated opt-out HIV testing of pregnant mothers, with a risk of becoming involuntary testing in a clinical setting, are acceptable. The rationale behind this is that the increased availability of very effective and inexpensive life-saving drugs makes the ethical problems raised by the possible intrusiveness of HIV testing less important than the child's hypothetical preferences to be born healthy. Health care providers, therefore, have a duty to offer both opt-out HIV testing and available PMTCT (preventing mother-to-child transmission) interventions. (shrink)

Zika infection in pregnant women is associated with an elevated probability of giving birth to a child with microcephaly and multiple other disabilities. Public health messaging on Zika prevention has predominantly targeted women who know they are pregnant or intend to become pregnant, but not teenage females for whom unintended pregnancy is more likely. Vulnerabilities among this population to reproductive risks associated with Zika are further amplified by restrictive abortion laws in several Zika-impacted states. Key (...) to prevention is enhanced, targeted public health messaging centered on teens nationally and particularly in certain high-risk regions. (shrink)

The desire to have healthy and happy children is the most basic parental instinct. A parent's moral obligation to care for the child extends before the moment of birth back to the point of conception. In classical Jewish tradition, the Talmud itself offers pregnant women advice on how to improve the well-being of their offspring, such as eating parsley in order to have handsome children, drinking wine in order to bear healthy children, or eating coriander to have (...) especially plump children. We stand on the cusp of a new era today because an explosion of genetic knowledge in recent years has provided us the ability to pursue certain health and wellness advantages even before pregnancy has begun. Technology called preimplantation genetic diagnosis allows parents to screen the DNA of embryos fertilized in vitro and to implant only those embryos that match the parents' desired genetic makeup. This may include selecting only embryos guaranteed not to have a particular genetic disease, only embryos of one particular gender, or eventually even only embryos with a predisposition for certain traits such as height, eye color, or enhanced memory. (shrink)

Using data from the National Hospital Discharge Survey, this paper analyzes the effect of Medicaid eligibility expansions from 1985 to 1996 on the health insurance coverage of women giving birth. We find that the eligibility expansions reduced the proportion of pregnant women who were uninsured by approximately 10%, although the magnitude of this decrease is sensitive to specification. The decrease in the proportion of uninsured pregnant women came at the expense of a substantial reduction in (...) private insurance coverage (crowd-out) of at least 55%. Substantial crowd-out and the relatively small change in the proportion uninsured suggest that Medicaid eligibility expansions may have had small effects on infant and maternal health. (shrink)

Background To determine whether fetal care paediatric and maternal–fetal medicine specialists harbour differing attitudes about pregnancy termination for congenital fetal conditions, their perceived responsibilities to pregnant women and fetuses, and the fetus as a patient and whether self-perceived primary responsibilities to fetuses and women and views about the fetus as a patient are associated with attitudes about clinical care.Methods Mail survey of 434 MFM and FCP specialists .Results MFMs were more likely than FCPs to disagree with these (...) statements : ‘the presence of a fetal abnormality is not an appropriate reason for a couple to consider pregnancy termination’ ; ‘the effects that a child born with disabilities might have on marital and family relationships is not an appropriate reason for a couple to consider pregnancy termination’ ; and ‘the cost of healthcare for the future child is not an appropriate reason for a couple to consider pregnancy termination’ . 65% MFMs versus 47% FCPs disagreed that their professional responsibility is to focus primarily on fetal well-being . Specialists did not differ regarding the fetus as a separate patient. Responses about self-perceived responsibility to focus on fetal well-being were associated with clinical practice attitudes.Conclusions Independent of demographic and sociopolitical characteristics, FCPs and MFMs possess divergent ethical sensitivities regarding pregnancy termination, pregnant women and fetuses, which may influence clinical care. (shrink)

BackgroundThere is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a (...) low-risk obstetrical randomised controlled trial, as a case-study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands.ResultsThree themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment.ConclusionsHealthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women. (shrink)

How should the definition of “minimal risk” in the federal research regulations be interpreted in regard to pregnant women and fetuses? Surprisingly, there has been little discussion of this question. There is, after all, a substantial amount of published work addressing the question of how “minimal risk” should be interpreted. Similarly, there is a large body of literature on the ethics of research involving pregnant women and fetuses, particularly maternal-fetal surgery. However, in neither of these bodies (...) of work can one find an analysis of minimal risk in regard to fetuses or pregnant women.The concept of minimal risk is defined in the regulations as follows:Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (shrink)

As COVID-19 pandemic continued to propagate, millions of lives are currently at risk especially elderly, people with chronic conditions and pregnant women. Iraq is one of the countries affected by the COVID-19 pandemic. Currently, in Iraq, there is a need for a self-assessment tool to be available in hand for people with COVID-19 concerns. Such a tool would guide people, after an automated assessment, to the right decision such as seeking medical advice, self-isolate, or testing for COVID-19. (...) This study proposes an online COVID-19 self-assessment tool supported by the internet of medical things (IoMT) technology as a means to fight this pandemic and mitigate the burden on our nation’s healthcare system. Advances in IoMT technology allow us to connect all medical tools, medical databases, and devices via the internet in one collaborative network, which conveys real-time data integration and analysis. Our IoMT framework-driven COVID-19 self-assessment tool will capture signs and symptoms through multiple probing questions, storing the data to our COVID-19 patient database, then analyze the data to determine whether a person needs to be tested for COVID-19 or other actions may require to be taken. Further to this, collected data can be integrated and analyzed collaboratively for developing a national health policy and help to manage healthcare resources more efficiently. The IoMT framework-driven online COVID-19 self-assessment tool has a big potential to prevent our healthcare system from being overwhelmed using real-time data collection, COVID-19 databases, analysis, and management of people with COVID-19 concerns, plus providing proper guidance and course of action. (shrink)

Prenatal screening and testing are preference‐based health care options. They are offered so that pregnant women and their partners can learn genetic information about the developing fetus. In this literature review, I summarize studies of women’s and their partners’ psychological responses to prenatal testing and screening. These studies investigate the experiences of pregnant women, largely in the United States, who have access to health care services. Although the results indicate that these women are receptive (...) to prenatal testing and screening and seem to have limited negative psychological consequences, pregnant women without access to these services are not represented and may have different experiences. With that caveat in mind, based on the evidence, women generally do well psychologically as they manage the options that arise for them in the prenatal context. (shrink)

This qualitative cross-sectional survey, undertaken in the antenatal booking clinics of a hospital in central London, explores pregnant women’s responses to routine HIV testing, examines their reasons for declining or accepting the test, and assesses how far their responses fulfil standard criteria for informed consent. Of the 32 women interviewed, only 10 participants were prepared for HIV testing at their booking interview. None of the women viewed themselves as being particularly at risk for HIV infection. The (...) minority of the participants who declined testing differed from those who accepted, by interpreting test acceptance as risky behaviour, privileging the negative outcomes of HIV positivity and expressing an inability to cope with these, should they occur. Troublingly, only a minority of women had a broad understanding of the rationale for the test, and none fulfilled the standard criteria for informed consent. This study suggests that, although routine screening combined with professional recommendation may be successful in increasing uptake, this may be at the cost of eroding informed consent. Protecting third parties from a preventable disease may outweigh the moral duty of respecting autonomy, enshrined in Western bioethical tradition. Nevertheless, such a policy should be made transparent, debated in the public domain and negotiated with women seeking antenatal care. (shrink)

In this article, we use qualitative methodology to explore how 15 low‐income women of diverse sociocultural location construct and experience health and weight gain during pregnancy, as well as how they position themselves in relation to messages pertaining to weight gain, femininity and motherhood that they encounter in their lives. Discussing the findings through a feminist poststructuralist lens, we conclude that the participants are complex, fragmented subjects, interpellated by multiple and at times conflicting subject positions. While the discourse of (...) maternal responsibility (i.e. managing personal behaviours for the baby's health) is very much in evidence in their narratives, embodied experiences of pregnancy, lived experiences of financial constraints and religious beliefs provided some with an alternative discourse and resistant subject position. Participants also had mixed emotions about weight gain; they recognized the need to gain weight in order to have a healthy pregnancy, but weight gain was also not welcome as participants reproduced the dominant discourse of obesity and the discourse of ‘feminine’ bodily norms. Based on our results, we advocate for change to recent clinical guidelines and social discourses around pregnancy and weight gain, as well as for policies that provide pregnant women with a range of health‐promoting resources. (shrink)

We analyzed the patients’ perception of prenatal diagnosis of fetal cardiac pathology, and the reasons for choosing to continue with pregnancy despite being eligible to receive a medical termination of pregnancy. We also identified the challenges, the motives interfering in decision-making, and the consequences of the decisions on pregnancy, child and mother. This descriptive, prospective and longitudinal study was conducted in France, amongst pregnant women who wished to continue their pregnancy despite an unfavorable medical advice. Socio-demographic data (...) were collected through a questionnaire. Such questionnaire covered information assessing the parents/mother’s perception of prenatal diagnosis, and medical termination of pregnancy, their interpretation of the established diagnosis and their motives for not considering pregnancy termination. 72 eligible patients were analyzed over one year: mean age 33 ± 6.89 years, 47 patients had already given birth to ≥1 healthy child. Mean gestational age at the detection of fetal cardiac pathologies was 30 ± 4.37 weeks of amenorrhea. Patients decided to keep the child after 3 ± 1.25 consultations. 56 patients made their decision with their husbands and 16 made their decision alone. Reasons for declining the medical termination were culpability and responsibility, ideologies and convictions, mistrust and hope. Newborns of 67 patients died with a mean survival duration of 38 days. Patient informed consent should be sought before any decision in neonatology, even if conflicting with the medical team’s knowledge and the pregnant mother’s benefits. Decisions to accept or decline pregnancy termination depend on the patients’ psychological character, ideologies, convictions, and mistrust in the diagnosis/prognosis, or hope in the fetus survival. (shrink)