A Trauma-informed Approach to Postpartum Care.

Distressing or traumatic perinatal experiences and adverse health outcomes can lead to particularly challenging postpartum experiences for patients and families. By adopting a trauma-informed care approach, the health care team can provide much-needed support, prevent additional harm, and promote healing. We propose practical communication, behavioral, and procedural considerations for integrating trauma-informed care principles into routine postpartum care, with attention to populations that have been marginalized. We see postpartum care as a critical component of holistic patient recovery and an opportunity to facilitate posttraumatic growth so that all families can thrive.

Responding to patient requests for women obstetrician-gynecologists.

Patients may request care from a woman obstetrician-gynecologist for various reasons, including privacy concerns, religious or cultural reasons, and in some cases, a history of abuse. They should be given the opportunity to voice their reasons for requesting a woman obstetrician-gynecologist but should not be compelled to do so. Respect for patient autonomy is a compelling reason to consider honoring a patient's gender-based request. When a patient requests a woman obstetrician-gynecologist, efforts should be made to accommodate the request if possible. However, medical professionals and institutions are not ethically obligated to have a woman obstetrician-gynecologist on call or to make one available at all times. If it is not feasible for a woman obstetrician-gynecologist to provide care because of staffing or other system constraints or patient safety concerns, accommodation is not required, and physicians do not have an overriding responsibility to ensure that patients receive gender-concordant care. Patients have the right to decline care and may choose to seek care elsewhere if their requested healthcare provider type is not available. Institutions and medical clinics should have policies and procedures in place for managing patient requests for women obstetrician-gynecologists, and patients should be made aware of these policies preemptively. These policies and procedures should include information about whom to contact for assistance and how to document the encounter. They should also be accessible and familiar to physicians and trainees. Care should be taken to ensure that adequate educational opportunities in obstetrics and gynecology are available for all medical trainees, regardless of gender.

Assessing Preconception Wellness in the Clinical Setting Using Electronic Health Data.

Background: One key strategy to reduce maternal morbidity and mortality involves optimizing prepregnancy health. Although nine core indicators of preconception wellness (PCW) have been proposed by clinical experts, few studies have attempted to assess the preconception health status of a population using these indicators. Methods: We conducted a retrospective chart review study of patients who received prenatal or primary care, identified by pregnancy-related ICD-10 codes, at either of two health systems in geographically and socioeconomically different areas of North Carolina between October 1, 2015, and September 30, 2018. Our primary study aim was to determine the feasibility of measuring the proposed PCW indicators through retrospective review of prenatal electronic health records at these two institutions. Results: Data were collected from 15,384 patients at Site 1 and 6,983 patients at Site 2. The indicators most likely to be documented and to meet the preconception health goal at each site were avoidance of teratogenic medications (98.8% and 98.3% at Sites 1 and 2, respectively) and entry to care in the first trimester (64.5% and 73.5% at Sites 1 and 2, respectively), whereas our measures of folic acid use, depression screening, and discussion of family planning were documented less than 20% of the time at both sites. Conclusions: Differences in measuring and documenting PCW indicators across the two health systems in our study presented barriers to monitoring and optimizing PCW. Efforts to address health and wellness before pregnancy will likely require health systems and payors to standardize, incorporate, and promote preconception health indicators that can be consistently measured and analyzed across health systems.

Ending the evidence gap for pregnancy, HIV and co-infections: ethics guidance from the PHASES project.

INTRODUCTION: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research. DISCUSSION: The 26-member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics-centred guidance for advancing timely, responsible HIV/co-infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug-related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post-approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co-infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. CONCLUSIONS: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for - and the promise of - advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.

IRB Decision-Making about Minimal Risk Research with Pregnant Participants.

Pregnant individuals are often excluded from research without clear justification, even when the research poses minimal risk of harm to the fetus. Little is known about institutional review board (IRB) decision-making practices when reviewing such research. We conducted a survey of current and former IRB personnel in the United States to elicit their interpretations of "minimal risk"-a formal regulatory category-and to identify factors that may influence IRB decisions to approve or disapprove research involving pregnant participants. Study results revealed some consensus among IRB members about the risk level of individual research procedures and hypothetical study vignettes. However, we uncovered important variations not only in the assessment of risk but also in the willingness of IRB members to approve minimal risk research that includes pregnant women. Based on our findings, guidance is needed to assist IRB members in characterizing risk, applying federal regulations, and appropriately ensuring the inclusion or justified exclusion of pregnant people in research.

Education in Trauma-Informed Care in Maternity Settings Can Promote Mental Health During the COVID-19 Pandemic.

Globally, the pandemic has adversely affected many people's mental health, including pregnant women and clinicians who provide maternity care, and threatens to develop into a mental health pandemic. Trauma-informed care is a framework that takes into account the effect that past trauma can have on current behavior and the ability to cope and can help to minimize retraumatization during health care encounters. The purpose of this article is to highlight the pressing need for perinatal clinicians, including nurses, midwives, physicians, doulas, nurse leaders, and nurse administrators, to be educated about the principles of trauma-informed care so that they can support the mental health of pregnant women, themselves, and members of the care team during the pandemic.

Intersectionality in Clinical Medicine: The Need for a Conceptual Framework.

Intersectionality has become a significant intellectual approach for those thinking about the ways that race, gender, and other social identities converge in order to create unique forms of oppression. Although the initial work on intersectionality addressed the unique position of black women relative to both black men and white women, the concept has since been expanded to address a range of social identities. Here we consider how to apply some of the theoretical tools provided by intersectionality to the clinical context. We begin with a brief discussion of intersectionality and how it might be useful in a clinical context. We then discuss two clinical scenarios that highlight how we think considering intersectionality could lead to more successful patient-clinician interactions. Finally, we extrapolate general strategies for applying intersectionality to the clinical context before considering objections and replies.

Views of American OB/GYNs on the ethics of prenatal whole-genome sequencing.

OBJECTIVE: Given public demand for genetic information, the potential to perform prenatal whole-genome sequencing (PWGS) non-invasively in the future, and decreasing costs of whole-genome sequencing, it is likely that OB/GYN practice will include PWGS. The goal of this project was to explore OB/GYNs' views on the ethical issues surrounding PWGS and their preparedness for counseling patients on its use. METHODS: A national survey was administered to 2500 members of American Congress of Obstetricians and Gynecologists. RESULTS: A total of 1114 respondents completed the survey (response rate = 45%). OB/GYNs are most concerned with ordering non-medical fetal genetic information, are worried about increasing parental anxiety, and feel it is appropriate to be directive when counseling parents about PWGS. Furthermore, most OB/GYNs have limited knowledge of genetics, rely heavily on genetic counselors and would like more guidance regarding the clinical adoption of PWGS. CONCLUSION: OB/GYNs do not completely accept or reject PWGS, but a substantial number have significant ethical and practical concerns. They are most concerned with issues that will directly affect their practices and interactions with patients, such as increasing parental anxiety and costs of care. Professional guidance would be instrumental in directing the adoption of PWGS and alleviating the ethical burden posed by PWGS on individual OB/GYNs. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

The Performance of Fertility Awareness-based Method Apps Marketed to Avoid Pregnancy.

INTRODUCTION: In recent years there has been an explosion in the development of medical apps, with more than 40,000 apps now available. Nearly 100 apps allow women to track their fertility and menstrual cycles and can be used to avoid or achieve pregnancy. Apps offer a convenient way to track fertility biomarkers. However, only some use evidence-based fertility awareness-based methods (FABMs), which with ideal use have rates of effectiveness similar to those of commonly used forms of hormonal birth control. Since having a baby or preventing a pregnancy are important responsibilities, it is critical that women and couples have access to reliable, evidence-based apps that allow them to accurately track their fertility. METHODS: We developed a tool to evaluate and rate fertility apps. This tool is specifically designed to help couples avoid pregnancy. RESULTS: Results showed that the majority of fertility apps are not based on evidence-based FABMs or include a disclaimer discouraging use for avoiding pregnancy. However, at least 1 app in each FABM category (except symptohormonal methods) had a perfect score on accuracy. CONCLUSION: Relying solely on an app to use an FABM, without appropriate training in the method, may not be sufficient to prevent pregnancy.

Bioethicists Can and Should Contribute to Addressing Racism.

The problems of racism and racially motivated violence in predominantly African American communities in the United States are complex, multifactorial, and historically rooted. While these problems are also deeply morally troubling, bioethicists have not contributed substantially to addressing them. Concern for justice has been one of the core commitments of bioethics. For this and other reasons, bioethicists should contribute to addressing these problems. We consider how bioethicists can offer meaningful contributions to the public discourse, research, teaching, training, policy development, and academic scholarship in response to the alarming and persistent patterns of racism and implicit biases associated with it. To make any useful contribution, bioethicists will require preparation and should expect to play a significant role through collaborative action with others.

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.

Abuse survivor perspectives on trauma inquiry in obstetrical practice.

PURPOSE: The objective of this study was to explore abuse survivor perspectives on optimal physician approaches to trauma inquiry in prenatal care. METHODS: Focus group involving six adult female abuse survivors. RESULTS: Five themes emerged for framing "safe" trauma inquiry: (1) a clear definition of trauma, (2) clear purpose for inquiry, (3) reassurance that inquiry was routine, (4) confidentiality, and (5) mention of helpful resources other than psychiatric therapy. CONCLUSIONS: Explaining the purpose of trauma inquiry may be important for effectively engaging abuse survivors in obstetrics.

Accelerating the paradigm shift toward inclusion of pregnant women in drug research: Ethical and regulatory considerations.

Although there has been long-standing reluctance to include pregnant women as clinical trial participants, increasing recognition of profound gaps in research on the safety and efficacy of drugs often prescribed to pregnant women calls into question the practice of routinely excluding them. This article presents compelling reasons for including pregnant women in clinical research, highlights certain regulatory barriers to the inclusion of pregnant women, and proposes that professional societies with expertise in obstetrics and maternal-fetal medicine can be instrumental in hastening the paradigm shift from the systematic exclusion of pregnant women in research to a one of responsible and fair inclusion.

Ethical considerations for designing GBS maternal vaccine efficacy trials in low-middle income countries.

Many in the scientific community agree that a randomized, placebo-controlled trial would offer the most scientifically rigorous study design for establishing the efficacy of a Group B Streptococcus (GBS) vaccine administered to pregnant women for the prevention of invasive GBS disease in young infants. There are compelling reasons to conduct such a trial in low-middle income countries (LMICs) with a high burden of disease, such as South Africa, and to adopt an add-on trial design in which participants are randomized to receive the GBS vaccine or placebo in addition to the locally available standard of care. Yet there is a longstanding debate about whether trials in LMICs should offer participants the worldwide best available standard of care. In this article, we examine both the risk-benefit profile and the potential for exploitation with an add-on trial design in the context of the locally available standard of care in South Africa. Our analysis suggests that providing the local standard of care to participants in this case may be not only more scientifically valuable but also more ethically acceptable than attempting to provide the worldwide best available standard of care in the South African setting. Moreover, the example of GBS in the South African setting can help to elucidate important ethical considerations for determining the acceptability of testing vaccine efficacy in the context of locally available rather than the worldwide best available standard of care in Phase III trials of other new maternal vaccines.

Responding to prenatal disclosure of past sexual abuse.

The American College of Obstetricians and Gynecologists recommends that physicians elicit a sexual abuse and rape trauma history for every patient, yet, in practice, physicians still may struggle to understand how best to obtain this history and what clinical obligations arise when a physician inquires and a woman discloses a remote history of childhood or adult sexual trauma during the course of her prenatal care. This commentary offers a practical strategy for responding to sexual trauma disclosure by developing a tailored obstetric care plan for avoiding retraumatization in labor. In this way, obstetricians may avoid causing harm and begin to meet the unique obstetric and psychological needs of sexual trauma survivors during pregnancy and delivery.