Home Birth in the United States: An Evidence-Based Ethical Analysis.

AbstractThe assumption in current U.S. mainstream medicine is that birthing requires hospitalization. In fact, while the American College of Obstetricians and Gynecologists supports the right of every birthing person to make a medically informed decision about their delivery, they do not recommend home birth owing to data indicating greater neonatal morbidity and mortality. In this article, we examine the evidence surrounding home birth in the United States and its current limitations, as well as the ethical considerations around birth setting.

U.S. Healthcare Provider Views and Practices Regarding Planned Birth Setting.

AbstractBackground: Little is known about U.S. healthcare provider views and practices regarding evidence, counseling, and shared decision-making about in-hospital versus out-of-hospital birth settings. METHODS: We conducted 19 in-depth, semistructured, qualitative interviews of eight obstetricians, eight midwives, and three pediatricians from across the United States. Interviews explored healthcare providers' interpretation of the current evidence and their personal and professional experiences with childbirth within the existing medical, ethical, and legal context in the United States. RESULTS: Themes emerged concerning risks and benefits, decision-making, and patient-provider power dynamics. Collectively, the narratives illuminated fundamental ideological tensions between in- and out-of-hospital providers arising from divergent assignment of value to described risks and benefits. The majority of physicians focused on U.S.-specific data demonstrating increased neonatal morbidity and mortality associated with delayed access to hospital-based interventions, thereby justifying hospital birth as the standard of care. By contrast, midwives emphasized data demonstrating fewer interventions and superior maternal and neonatal outcomes in high-income European countries, where out-of-hospital birth is more common for low-risk birthing people. A key gap in counseling was revealed, as no interviewees offered anticipatory counseling regarding birth setting options. Providers directly and indirectly illustrated the propensity for asymmetric power relations between birth providers and pregnant people, especially in hospital settings. CONCLUSIONS: The narratives highlight the common goal of optimizing maternal and neonatal outcomes despite tensions arising from divergent prioritization of specific maternal and neonatal risks. Our findings suggest opportunities to foster collaboration and optimize outcomes via mutual respect and improved integration of care.

Perceived Value of Prenatal Ultrasound Screening: A Survey of Pregnant Women.

INTRODUCTION: Routine prenatal screening ultrasounds primarily serve to diagnose major fetal anomalies which may prompt further testing and inform clinical decision-making, including possible pregnancy termination. Meanwhile, expectant parents may view the ultrasound experience and information gained differently from their clinicians. In this setting, how to best counsel patients, especially regarding the increasing findings of indeterminant clinical significance, is unclear. Greater understanding of women's views before undergoing their ultrasound may help to guide anticipatory counseling about the purpose of screening and interpretation of results. METHODS: We surveyed 289 patients presenting for scheduled prenatal ultrasounds at an academic tertiary care center. Discrete and open-ended questions assessed views surrounding the receipt of abnormal results and management of the pregnancy once fetal anomalies are detected. Qualitative responses were analyzed using thematic analysis. RESULTS: Most (95%) desired information about abnormal sonographic findings, although only half would consider pregnancy termination for anomalies. Reasons for wanting return of abnormal results included preparedness, valuing knowledge, and to a lesser extent, informing decision-making. When considering potential termination as a result of ultrasound findings, participants' rationales demonstrated deontological (seeing termination as inherently impermissible or permissible), relational (duties arising from the role of being a mother), and consequentialist (weighing harms and benefits) reasoning. CONCLUSION: This study highlights women's perceptions of prenatal ultrasounds as an inherently valuable source of information and preparedness, beyond their role in informing clinical decision-making. Identifying the ethical constructs underpinning patients' perspectives may help direct development of counseling tools responsive to individual needs and values regarding prenatal ultrasound findings.

Respect, justice and learning are limited when patients are deidentified data subjects.

Introduction: Critical for advancing a Learning Health System (LHS) in the U.S., a regulatory safe harbor for deidentified data reduces barriers to learning from care at scale while minimizing privacy risks. We examine deidentified data policy as a mechanism for synthesizing the ethical obligations underlying clinical care and human subjects research for an LHS which conceptually and practically integrates care and research, blurring the roles of patient and subject. Methods: First, we discuss respect for persons vis-a-vis the systemic secondary use of data and tissue collected in the fiduciary context of clinical care. We argue that, without traditional informed consent or duty to benefit the individual, deidentification may allow secondary use to supersede the primary purpose of care. Next, we consider the effectiveness of deidentification for minimizing harms via privacy protection and maximizing benefits via promoting learning and translational care. We find that deidentification is unable to fully protect privacy given the vastness of health data and current technology, yet it imposes limitations to learning and barriers for efficient translation. After that, we evaluate the impact of deidentification on distributive justice within an LHS ethical framework in which patients are obligated to contribute to learning and the system has a duty to translate knowledge into better care. Such a system may permit exacerbation of health disparities as it accelerates learning without mechanisms to ensure that individuals' contributions and benefits are fair and balanced. Results: We find that, despite its established advantages, system-wide use of deidentification may be suboptimal for signaling respect, protecting privacy or promoting learning, and satisfying requirements of justice for patients and subjects. Conclusions: Finally, we highlight ethical, socioeconomic, technological and legal challenges and next steps, including a critical appreciation for novel approaches to realize an LHS that maximizes efficient, effective learning and just translation without the compromises of deidentification.

Patient caught breastfeeding and instructed to stop: an empirical ethics study on marijuana and lactation.

BACKGROUND: The US guidelines recommend avoiding marijuana during breastfeeding given concerns about infant's neurodevelopment. In this setting, some physicians and hospitals recommend against or prohibit breastfeeding when marijuana use is detected during pregnancy. However, breastfeeding is beneficial for infants and women, and stigmatization of substance use in pregnancy has been historically linked to punitive approaches with a disproportionate impact on minority populations. We advance an empirically informed ethical analysis of this issue. METHODS: First, we performed a retrospective cross-sectional qualitative study of prenatal and postpartum records from a random sample of 150 women delivered in an academic hospital system in 2017 to provide evidence and context regarding breastfeeding management in relation to marijuana use. We then perform a scoping literature review on infant risks from breastmilk marijuana exposure and risks associated with not breastfeeding for infants and women. Finally, we analyze this issue vis-a-vis ethical principles of beneficence, autonomy, and justice. RESULTS: (1) Medical records reveal punitive language pertaining to the medicinal use of marijuana in pregnancy and misinterpretation of national guidelines, e.g., "patient caught breastfeeding and instructed to stop." (2) Though there are plausible neurodevelopmental harms from breastmilk exposure to THC, evidence of infant effects from breastmilk exposure to marijuana is limited and largely confounded by concomitant pregnancy exposure and undisclosed exposures. By contrast, health benefits of breastfeeding for women and infants are well-established, as are harms of forgoing breastfeeding. (3) Discouraging breastfeeding for women with marijuana use in pregnancy contradicts beneficence, as it neglects women's health considerations and incorrectly assumes that risks exceed benefits for infants. Restrictive hospital practices (e.g., withholding lactation support) compromise maternal autonomy and exploit power asymmetry between birthing persons and institutions, particularly when compulsory toxicology screening prompts child welfare investigations. Finally, recommending against breastfeeding during prenatal care and imposing restrictions during postpartum hospitalization may exacerbate racial disparities in breastfeeding and related health outcomes. CONCLUSIONS: Policy interpretations which discourage rather than encourage breastfeeding among women who use of marijuana may cause net harm, compromise autonomy, and disproportionately threaten health and wellbeing of underserved women and infants.

Pregnant Individuals' Views on Fetal Tissue Research in the United States.

OBJECTIVE: Fetal tissue research has driven significant medical advances but remains publicly contentious in the United States. The views of pregnant individuals in the United States regarding the donation of fetal tissue offer an important and previously unexplored perspective on this issue. METHODS: We conducted a secondary analysis of data from two separate, broader qualitative studies. Pregnant and recently pregnant individuals (N=79) from clinical sites at the University of North Carolina at Chapel Hill, Johns Hopkins University, and Massachusetts General Hospital were interviewed individually using a semi-structured guide addressing a range of issues related to infectious disease research and pregnancy, including the acceptability of fetal tissue research. Interviews were transcribed, coded, and analyzed for emergent themes. RESULTS: Among this sample of predominantly Black (61%), reproductive-aged pregnant and recently pregnant participants, the majority (72%) generally supported fetal tissue research. The following three themes were identified: choice, respect, and meaning. Respondents discussed the deeply personal nature of decisions surrounding fetal tissue research, emphasizing the importance of informed consent and respect for the person's emotional state when approaching for consent. The ways in which participants regarded how to respectfully handle fetal tissue also shaped views about the acceptability of donation, both for and against. For many participants, fetal tissue donation to research represented one way of ascribing meaning to pregnancy termination or loss. CONCLUSION: Among this diverse sample of pregnant and recently pregnant individuals, most were supportive of fetal tissue donation for research. A better understanding of pregnant individuals' views on this topic may lead to policies and practices that are congruent with the needs and values of people facing decisions regarding the disposition of fetal remains.

Indeterminate Prenatal Ultrasounds and Maternal Anxiety: A Prospective Cohort Study.

INTRODUCTION: Prenatal ultrasounds often yield indeterminate (incomplete or minor abnormality) findings with limited clinical utility. We evaluate impact of indeterminate findings on maternal anxiety. METHODS: A single-U.S.-center prospective cohort study administered the Perinatal Anxiety Screening Scale (PASS; control mean = 13.4; > 20 denotes clinically significant anxiety) before and after prenatal ultrasounds in February-May 2017. Ultrasound reports were coded as: normal; indeterminate; or major abnormality. Primary outcome was anxiety after indeterminate vs. normal ultrasounds. Secondary outcomes included anxiety change from pre-to-post-ultrasound and relative to women's characteristics. Linear regression adjusted for confounders. RESULTS: Of 286 ultrasounds, 51.0% were normal, 40.5% indeterminate (22.0% incomplete; 18.5% minor abnormality), and 8.0% major abnormalities. Indeterminate findings were unrelated to age, race, parity, infertility, or psychiatric history, but associated with gestational age (26.6%/45.0%/52.5% for first/second/third trimesters; p < 0.001), and obesity (48.8 vs. 37.0%; p = 0.031). Pretest anxiety was highest in second/third trimesters (p = 0.029), and in subjects aged age ≤ 24 or younger(p < 0.001), with a history of anxiety (p < 0.001),) or with prior pregnancy loss (p = 0.011). Mean anxiety score decreased pre-to-posttest across all groups. Indeterminate findings were associated with higher PASS scores than normal findings: pretest 20.1 vs. 16.4 (p = 0.026) and posttest 16.9 vs. 12.2 (p = 0.009; adjusted-p = 0.01). Versus normal ultrasounds, incomplete findings were associated with higher post-ultrasound anxiety (p = 0.007; adjusted-p = 0.01) and smaller decreases from pre-to-posttest (adjusted-p = 0.03), whereas minor abnormalities had higher pretest anxiety (p = 0.029) with larger pre-to-posttest decreases (adjusted-p =0.010). DISCUSSION: Indeterminate ultrasounds, especially incomplete findings, are associated with significantly higher anxiety than normal findings, suggesting need for evidence-based counseling, management and strategies for decreasing number of indeterminate results.

Impact of Hospital Visitor Restrictions on Racial Disparities in Obstetrics.

Racial disparities in both obstetrics and COVID-19 are well documented. Troublingly, implicit biases and related testimonial injustice potentiate adverse outcomes for women of color whose voices and concerns have been historically discredited by the medical establishment. In the context of COVID-19, the restriction of hospital visitors for infection prevention and control in a labor and delivery setting may disproportionately burden black women by eliminating or severely limiting access to essential in-person advocacy, which threatens to exacerbate existing disparities in maternal and neonatal outcomes. The potential disproportionate impact of visitor restrictions on women of color should inform the ongoing pandemic response.

A Small-Town Heart.

Melanie presented at twenty weeks of gestation to an obstetrics clinic in a critical access hospital in rural Vermont. She was excited to undergo routine fetal ultrasonography, but her obstetrician gave her grave news: the ultrasound revealed hypoplastic left heart syndrome, a devastating congenital heart defect. Initially, Melanie agreed in general to pursue surgical care for her fetus-a three-stage process that has somewhat uncertain results and could only be done in tertiary care facilities far from her home in Vermont. A week later, while the maternal fetal medicine and pediatric cardiology units made arrangements with colleagues in Boston, Melanie began having second thoughts. An ethics meeting was called to discuss conflicting clinician reactions to Melanie's dilemma. Most of the clinicians were stunned that the patient would change her mind. What advice should the ethics consultant offer the team about caring for Melanie?

HIV-, HBV-, and HCV-Related Information on U.S. Fertility Clinic Websites: A Content Analysis.

Purpose: People living with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus (PLHIV/HBV/HCV) face barriers to assisted reproductive technologies (ART), in part, due to laws and professional regulations mandating dedicated laboratory facilities and storage tanks for reproductive tissue to minimize theoretical risk of cross-contamination. These guidelines greatly increase the expense of providing equal care, however, fertility clinics are neither required to treat nor disclose whether they treat PLHIV/HBV/HCV. Clinics' websites are an important source of information regarding available services for prospective patients and referring providers. We assessed whether clinic websites disclose availability of ART for PLHIV/HBV/HCV. Methods: Websites for Society for Assisted Reproductive Technology-accredited clinics in Northeast and South Atlantic United States were searched systematically for HIV-, HBV-, or HCV-specific content. Qualitative and thematic analysis was performed. Clinic characteristics (annual volume, practice setting) were collected. Results: Of 136 websites, nine (6.6%) had information relevant to PLHIV seeking infertility treatment, and seven (5.1%) offered at least some treatments. Three clinics (2.2%) also mentioned treatment information relevant for PLHBV/HCV, one of which offered treatment. Information was often difficult to find or interpret. By contrast, 77/136 (56.6%) of clinics mentioned universally screening patients for HIV and 77/136 (56.6%) mentioned screening for HBV/HCV before ART. Conclusion: Given economic disincentives to providing ART to PLHIV/HBV/HCV under current guidelines, the paucity of clinics openly offering treatment suggests a troubling lack of transparency or, possibly, a lack of available care. Further research should examine the impact of current guidelines and whether dedicated facilities and storage are medically indicated.

Rethinking "Elective" Procedures for Women's Reproduction during Covid-19.

Common hospital and surgical center responses to the Covid-19 pandemic included curtailing "elective" procedures, which are typically determined based on implications for physical health and survival. However, in the focus solely on physical health and survival, procedures whose main benefits advance components of well-being beyond health, including self-determination, personal security, economic stability, equal respect, and creation of meaningful social relationships, have been disproportionately deprioritized. We describe how female reproduction-related procedures, including abortion, surgical sterilization, reversible contraception devices and in vitro fertilization, have been broadly categorized as "elective," a designation that fails to capture the value of these procedures or their impact on women's overall well-being. We argue that corresponding restrictions and delays of these procedures are problematically reflective of underlying structural views that marginalize women's rights and interests and therefore threaten to propagate gender injustice during the pandemic and beyond. Finally, we propose a framework for triaging reproduction-related procedures during Covid-19 that is more individualized, accounts for their significance for comprehensive well-being, and can be used to inform resumption of operations as well as subsequent restriction phases.

Optimizing Medication Treatment of Opioid Use Disorder During COVID-19 (SARS-CoV-2).

: The COVID-19 health crisis joined, rather than supplanted, the opioid crisis as the most acutely pressing threats to US public health. In the setting of COVID-19, opioid use disorder treatment paradigms are being disrupted, including the fact that methadone clinics are scrambling to give "take-home" doses where they would typically not. The rapid transition away from in-person examination, dosing and group therapy in an era of social isolation calls for adjustments to clinical practice, including emphasizing patient-provider communication, favoring new inductees on buprenorphine and leveraging technology to optimize safety of medication treatment.

When separation is not the answer: Breastfeeding mothers and infants affected by COVID-19.

The World Health Organization (WHO) has provided detailed guidance on the care of infants of women who are persons under investigation (PUI) or confirmed to have COVID-19. The guidance supports immediate post-partum mother-infant contact and breastfeeding with appropriate respiratory precautions. Although many countries have followed WHO guidance, others have implemented infection prevention and control (IPC) policies that impose varying levels of post-partum separation and discourage or prohibit breastfeeding or provision of expressed breast milk. These policies aim to protect infants from the potential harm of infection from their mothers, yet they may fail to fully account for the impact of separation. Global COVID-19 data are suggestive of potentially lower susceptibility and a typically milder course of disease among children, although the potential for severe disease in infancy remains. Separation causes cumulative harms, including disrupting breastfeeding and limiting its protection against infectious disease, which has disproportionate impacts on vulnerable infants. Separation also presumes the replaceability of breastfeeding-a risk that is magnified in emergencies. Moreover, separation does not ensure lower viral exposure during hospitalizations and post-discharge, and contributes to the burden on overwhelmed health systems. Finally, separation magnifies maternal health consequences of insufficient breastfeeding and compounds trauma in communities who have experienced long-standing inequities and violence, including family separation. Taken together, separating PUI/confirmed SARS-CoV-2-positive mothers and their infants may lead to excess preventable illnesses and deaths among infants and women around the world. Health services must consider the short-andlong-term impacts of separating mothers and infants in their policies.

Respect women, promote health and reduce stigma: ethical arguments for universal hepatitis C screening in pregnancy.

In the USA, there are missed opportunities to diagnose hepatitis C virus (HCV) in pregnancy because screening is currently risk-stratified and thus primarily limited to individuals who disclose history of injection drug use or sexually transmitted infection risks. Over the past decade, the opioid epidemic has dramatically increased incidence of HCV and a feasible, well-tolerated cure was introduced. Considering these developments, recent evidence suggests universal HCV screening in pregnancy would be cost-effective and several professional organisations have called for updated national policy. Historically, universal screening has been financially disincentivised on the healthcare system level, particularly since new diagnoses may generate an obligation to provide expensive treatments to a population largely reliant on public health resources. Here, we provide ethical arguments supporting universal HCV screening in pregnancy grounded in obligations to respect for persons, beneficence and justice. First, universal prenatal HCV screening respects pregnant women as persons by promoting their long-term health outside of pregnancy. Additionally, universal screening would optimise health outcomes within current treatment guidelines and may support research on treatment during pregnancy. Finally, universal screening would avoid potential harms of risk-stratifying pregnant women by highly stigmatised substance use and sexual behaviours.

Women's views about contraception requirements for biomedical research participation.

The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies-often irrespective of risks and benefits or a woman's actual potential for pregnancy, raising important questions about when such requirements are appropriate. The perspectives of women themselves on these issues are largely unexplored. We conducted 140 interviews, 70 in the U.S. and 70 in Malawi, with women either living with or at-risk for HIV, exploring their views about the practice of requiring contraception in clinical trials. A majority of women interviewed from both countries indicated overall support for the practice, with seven themes characterizing advantages and disadvantages raised: reproductive control, health effects, prevention of fetal harm, burden on women, deferral to authority, autonomy regarding enrollment and birth control method, and relationship concerns. While women in the US frequently raised prevention of fetal harm as a key advantage, many other positives noted by women in both countries were related to contraception use in general, not specific to a trial context. With regard to disadvantages, U.S. women tended to focus on biomedical risks such as side effects and impact on fertility, whereas Malawian women focused on the social risks of contraception requirements, including violations of trust in marital relations and suspicions of potential infidelity. Given the potential benefits and burdens highlighted, contraception in research should be sensitive to actual fetal risk assessments; directed where justified at optimizing effective pregnancy prevention; responsive to women's reproductive preferences; and made available as an ancillary benefit even where risk thresholds do not justify requirement-in order to facilitate trials that are both ethical and robustly oriented around the interests and lives of women who will participate in them.

Breastfeeding with HIV: An Evidence-Based Case for New Policy.

To help eliminate perinatal HIV transmission, the US Department of Health and Human Services recommends against breastfeeding for women living with HIV, regardless of viral load or combined antiretroviral therapy (cART) status. However, cART radically improves HIV prognosis and virtually eliminates perinatal transmission, and breastfeeding's health benefits are well-established. In this setting, pregnancy is increasing among American women with HIV, and a harm reduction approach to those who breastfeed despite extensive counseling is suggested. We assess the evidence and ethical justification for current policy, with attention to pertinent racial and health disparities. We first review perinatal transmission and breastfeeding data relevant to US infants. We compare hypothetical risk of HIV transmission from breastmilk to increased mortality from sudden infant death syndrome, necrotizing enterocolitis and sepsis from avoiding breastfeeding, finding that benefits may outweigh risks if mothers maintain undetectable viral load on cART. We then review maternal health considerations. We conclude that avoidance of breastfeeding by women living with HIV may not maximize health outcomes and discuss our recommendation for revising national guidelines in light of autonomy, harm reduction and health inequities.