Anne Drapkin Lyerly

Clinical report - Maternal-fetal intervention and fetal care centers

The past 2 decades have yielded profound advances in the fields of prenatal diagnosis and fetal intervention. Although fetal interventions are driven by a beneficence-based motivation to improve fetal and neonatal outcomes, advancement in fetal therapies raises ethical issues surrounding maternal autonomy and decision-making, concepts of innovation versus research, and organizational aspects within institutions in the development of fetal care centers. To safeguard the interests of both the pregnant woman and the fetus, the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics make recommendations regarding informed consent, the role of research subject advocates and other independent advocates, the availability of support services, the multidisciplinary nature of fetal intervention teams, the oversight of centers, and the need to accumulate maternal and fetal outcome data.

Reframing the Framework: Toward Fair Inclusion of Pregnant Women as Participants in Research

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Prenatal exome sequencing in anomalous fetuses: new opportunities and challenges

PurposeWe investigated the diagnostic and clinical performance of exome sequencing in fetuses with sonographic abnormalities with normal karyotype and microarray and, in some cases, normal gene-specific sequencing.MethodsExome sequencing was performed on DNA from 15 anomalous fetuses and from the peripheral blood of their parents. Parents provided consent to be informed of diagnostic results in the fetus, medically actionable findings in the parents, and their identification as carrier couples for significant autosomal recessive conditions. We assessed the perceptions and understanding of exome sequencing using mixed methods in 15 mother−father dyads.ResultsIn seven (47%) of 15 fetuses, exome sequencing provided a diagnosis or possible diagnosis with identification of variants in the following genes: COL1A1, MUSK, KCTD1, RTTN, TMEM67, PIEZO1 and DYNC2H1. One additional case revealed a de novo nonsense mutation in a novel candidate gene (MAP4K4). The perceived likelihood that exome sequencing would explain the results (5.2 on a 10-point scale) was higher than the approximately 30% diagnostic yield discussed in pretest counseling.ConclusionExome sequencing had diagnostic utility in a highly select population of fetuses where a genetic diagnosis was highly suspected. Challenges related to genetics literacy and variant interpretation must be addressed by highly tailored pre- and posttest genetic counseling.

Stronger and More Vulnerable: A Balanced View of the Impacts of the NICU Experience on Parents

For parents, the experience of having an infant in the NICU is often psychologically traumatic. No parent can be fully prepared for the extreme stress and range of emotions of caring for a critically ill newborn. As health care providers familiar with the NICU, we thought that we understood the impact of the NICU on parents. But we were not prepared to see the children in our own families as NICU patients. Here are some of the lessons our NICU experience has taught us. We offer these lessons in the hope of helping health professionals consider a balanced view of the NICU’s impact on families.

Advancing HIV research with pregnant women: navigating challenges and opportunities.

Objective:Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. Methods:We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. Results:Experts discussed a breadth of needed research, including safety, efficacy, and appropriate dosing of: newer antiretrovirals for pregnant women, emerging preventive strategies, and treatment for coinfections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. Conclusion:Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel

Tuberculosis is a major cause of morbidity and mortality in women of childbearing age (15-44 years). Despite increased tuberculosis risk during pregnancy, optimal clinical treatment remains unclear: safety, tolerability, and pharmacokinetic data for many tuberculosis drugs are lacking, and trials of promising new tuberculosis drugs exclude pregnant women. To advance inclusion of pregnant and postpartum women in tuberculosis drug trials, the US National Institutes of Health convened an international expert panel. Discussions generated consensus statements (>75% agreement among panelists) identifying high-priority research areas during pregnancy, including: (1) preventing progression of latent tuberculosis infection, especially in women coinfected with human immunodeficiency virus; (2) evaluating new agents/regimens for treatment of multidrug-resistant tuberculosis; and (3) evaluating safety, tolerability and pharmacokinetics of tuberculosis drugs already in use during pregnancy and postpartum. Incorporating pregnant women into clinical trials would extend evidence-based tuberculosis prevention and treatment standards to this special population.

Reframing Conscientious Care: Providing Abortion Care When Law and Conscience Collide.

Much of the debate on conscience has addressed the ethics of refusal: the rights of providers to refuse to perform procedures to which they object and the interests of the patients who might be harmed by their refusals. But conscience can also be a positive force, grounding decision about offering care.

Ethics and Research with Pregnant Women: Lessons from HIV/AIDS

HIV/AIDS is among the most serious diseases confronting women who are pregnant. It is also one of the few areas of research involving humans where there is a long track record of research involving pregnant women. Yet the HIV/AIDS research community has struggled to expand the research agenda from research to prevent mother-to-child transmission of HIV to research encompassing issues pertaining to the pregnant woman’s own health. Research questions of interest include: which antiretrovirals are safest and most effective for pregnant women; how best to pursue preventive regimes for pregnant women who are not infected; or, how to treat HIV’s deadly co-infections, such as tuberculosis (TB), during pregnancy. In this chapter, we describe two key lessons about research in pregnancy from the context of HIV/AIDS: first, why addressing the health needs of pregnant women, not just the needs of their offspring, is so critical; and second, why doing so is immediately possible, even as we work to resolve certain ethical and regulatory debates, particularly about when it is appropriate to impose foetal risk without the prospect of foetal benefit. In particular, the HIV/AIDS context shows how treatment or prevention of maternal disease often entails not just risk – but the prospect of benefit – to the foetus; and creative trial designs can advance no-benefit studies without imposing foetal risk in the first place. For all the challenges that research with pregnant women entails, the HIV/AIDS context reveals that it is possible to conduct a wide range of important research during pregnancy that is both ethically responsible and consonant with US regulations.

The language of birth.

Our language both reflects and influences our attitudes and behavior. This Roundtable Discussion explores the language used in obstetrics and in the interactions between caregivers and women or their families: What do practitioners say to mothers and families during labor? At birth? In consultations? To describe what is happening? To encourage a womans efforts? To lighten the atmosphere? When advising about possible interventions? Medical terminology in perinatal care can often be deceptive or confusing, not only for mothers but for caregivers. The authors of this Roundtable, representing health professionals from different specialties and interests in the field, have examined some examples of such language use, misuse, and abuse in perinatal care. (BIRTH 39:2 June 2012).

“Prefacing the Script” as an ethical response to state-mandated abortion counseling

Abstract Background: Laws governing abortion provision are proliferating throughout the United States, yet little is known about how these laws affect providers. We investigated the experiences of abortion providers in North Carolina practicing under the 2011 Womans Right to Know Act, which mandates that women receive counseling with specific, state-prescribed information at least 24 hours prior to an abortion. We focus here on a subset of the data to examine one strategy by which providers worked to minimize moral conflicts generated by the counseling procedure. Drawing on Erving Goffmans work on language and social interaction, we highlight how providers communicated moral objections and layered meanings through a practice that we call prefacing the script. Methods: We conducted semistructured interviews with 31 physicians, nurses, physician assistants, and clinic managers who provide abortion care in North Carolina. Audio-recorded interviews were transcribed verbatim and analyzed using an inductive, iterative analytic approach, which included reading for context, interpretive memo-writing, and focused coding. Results: Roughly half of the participants (14/31) reported that they or the clinicians who performed the counseling in their institution routinely prefaced the counseling script with qualifiers, disclaimers, and apologies that clarified their relationship to the state-mandated content. We identified three performative functions of this practice: (1) enacting a frame shift from a medical to a legal interaction; (2) distancing the speaker from the authorial voice of the counseling script; and (3) creating emotional alignment. Conclusions: Prefacing state-mandated abortion counseling scripts constitutes a practical strategy providers use to balance the obligation to comply with state law with personal and professional responsibilities to provide tailored care, provide emotional support, and serve the patients best interests. Our findings suggest that language constitutes a powerful resource for navigating and minimizing moral conflicts in health care.