"I don't have a telephone to the fetus": Clinicians' conceptions of fetal patienthood in maternal-fetal surgery counseling.

RATIONALE: Maternal fetal surgery (MFS) has developed rapidly since the 1960s and centers for fetal diagnosis and therapy (CFDT) have proliferated. As a result, CFDT clinicians have intervened with fetuses through pregnant bodies for decades, yet the patienthood status of the fetus and its implications for the pregnant person's autonomy have been relatively unexamined. OBJECTIVE: Our overall research aims were threefold: (1) to explore how clinicians train for and provide counseling for MFS; (2) to examine how clinicians assess fetal patienthood and its implications; and (3) to understand clinicians' professed needs and their recommendations for education and training for the provision of MFS counseling. This focuses on aim two. METHOD: In this qualitative study, conducted using in-depth interviews, we examined how 20 clinicians from 17 different sites understood fetal patienthood, how that affected their counseling of pregnant patients, and whether they drew on extant ethical frameworks for guidelines. RESULTS: We identified three major themes: 1) Clinicians entered fetal surgery consultations with assumptions about fetal patienthood (frequently informed by beliefs about fetal viability, maternal attachment, and disciplinary perspectives); 2) they consciously assessed their pregnant patients' connections to their fetus to inform or re-calibrate their own understandings of fetal patienthood; and 3) they used a threshold -based conceptualization whereby the fetus achieved patienthood after crossing a symbolic boundary, often related to the clinician's ability to intervene. CONCLUSIONS: Few clinicians invoked an extant ethical framework to determine fetal patienthood; most asserted that they did not view directive counseling toward MFS as appropriate, instead working diligently to protect pregnant patients' autonomy and rights to self-determination.

Mammalian target of rapamycin inhibitors: A new-possible approach for in-utero medication therapy.

The mammalian/mechanistic target of rapamycin (mTOR) is a protein kinase that plays a crucial role in regulating cellular growth, metabolism, and survival. Although there is no absolute contraindication for the use of mTOR inhibitors during pregnancy, the specific fetal effects remain unknown. Available data from the past 2 decades have examined the use of mTOR inhibitors during pregnancy in patients with solid organ transplantation, showing no clear link to fetal complications or structural abnormalities. Recently, a handful of case reports and series have described transplacental therapy of mTOR inhibitors to control symptomatic and complicated pathologies in the fetus. The effect of these agents includes a significant reduction in lesion size in the fetus and a reduced need for mechanical ventilation in neonates. In this context, we delve into the potential of mTOR inhibitors as in-utero therapy for fetal abnormalities, with a primary focus on lymphatic malformation (LM) and cardiac rhabdomyoma (CR). While preliminary reports underscore the efficacy of mTOR inhibitors for the treatment of fetal CR and fetal brain lesions associated with tuberous sclerosis complex, chylothorax, and LMs, additional investigation and clinical trials are essential to comprehensively assess the safety and efficacy of these medications.

"We All Want to Be Able to Tell You Something Hopeful": Clinicians' Experiences Providing Maternal-Fetal Surgery Counseling.

INTRODUCTION: Prenatal counseling about maternal-fetal surgery can be traumatic and confusing for pregnant people. It can also be technically and emotionally complex for clinicians. As maternal-fetal surgery rapidly advances and becomes more common, more evidence is needed to inform counseling practices. The objective of this study was to develop a deeper understanding of the methods clinicians currently use to train for and provide counseling, as well as their needs and recommendations for future education and training. METHODS: We used interpretive description methods and interviewed interprofessional clinicians who regularly counsel pregnant people about maternal-fetal surgery. RESULTS: We conducted 20 interviews with participants from 17 different sites who were maternal-fetal medicine specialists (30%), pediatric surgeons (30%), nurses (15%), social workers (10%), a genetic counselor (5%), a neonatologist (5%), and a pediatric subspecialist (5%). Most were female (70%), non-Hispanic white (90%), and practiced in the Midwest (50%). We identified four overarching themes: (1) contextualizing maternal-fetal surgery counseling; (2) establishing shared understanding; (3) supporting decision-making; and (4) training for maternal-fetal surgery counseling. Within these themes, we identified key practice differences among professions, specialties, institutions, and regions. CONCLUSION: Participants are committed to practicing informative and supportive counseling to empower pregnant people to make autonomous decisions about maternal-fetal surgery. Nevertheless, our findings indicate a dearth of evidence-based communication practices and guidance. Participants identified significant systemic limitations affecting pregnant people's decision-making options related to maternal-fetal surgery.

The exciting potential for ChatGPT in obstetrics and gynecology.

Natural language processing-the branch of artificial intelligence concerned with the interaction between computers and human language-has advanced markedly in recent years with the introduction of sophisticated deep-learning models. Improved performance in natural language processing tasks, such as text and speech processing, have fueled impressive demonstrations of these models' capabilities. Perhaps no demonstration has been more impactful to date than the introduction of the publicly available online chatbot ChatGPT in November 2022 by OpenAI, which is based on a natural language processing model known as a Generative Pretrained Transformer. Through a series of questions posed by the authors about obstetrics and gynecology to ChatGPT as prompts, we evaluated the model's ability to handle clinical-related queries. Its answers demonstrated that in its current form, ChatGPT can be valuable for users who want preliminary information about virtually any topic in the field. Because its educational role is still being defined, we must recognize its limitations. Although answers were generally eloquent, informed, and lacked a significant degree of mistakes or misinformation, we also observed evidence of its weaknesses. A significant drawback is that the data on which the model has been trained are apparently not readily updated. The specific model that was assessed here, seems to not reliably (if at all) source data from after 2021. Users of ChatGPT who expect data to be more up to date need to be aware of this drawback. An inability to cite sources or to truly understand what the user is asking suggests that it has the capability to mislead. Responsible use of models like ChatGPT will be important for ensuring that they work to help but not harm users seeking information on obstetrics and gynecology.

The far-reaching impact of abortion bans: reproductive care and beyond.

On 24 June 2022, the US Supreme Court overturned Roe v. Wade, a 49-year-old precedent that provided federal constitutional protection for abortions up to the point of foetal viability, returning jurisdiction to the individual states. Restrictions that came into effect automatically in several states, and are anticipated in others, will severely limit access to abortions in approximately half of the US. Even though every state allows for exceptions to the abortion bans, in some instances these exceptions can be used to preserve the health of a pregnant patient, while in other instances, only to preserve their life. The vague and confusing nature of the abortion ban exceptions threatens to compromise the standard of care for patients with pregnancy complications that are distinct from abortions, such as nonviable pregnancies, miscarriages, and ectopic pregnancies. Additionally, we envision challenges for the treatment of women with certain autoimmune conditions, pregnant cancer patients, and patients contemplating preimplantation genetic diagnosis as part of assisted reproductive technologies. The abortion ban exceptions will impact and interfere with the medical care of pregnant and non-pregnant patient populations alike and are poised to create a medical and public health crisis unlike any other one from the recent past.

Sociodemographic Factors Associated With Gonorrhea and Chlamydia Infection in Pregnancy.

BACKGROUND: We explored the impact of maternal sociodemographic parameters on the prevalence of chlamydial and gonorrheal infection in pregnancy in a large United States population of live births. METHODS: Retrospective analysis of the Centers for Disease Control and Prevention Natality Live Birth database (2016-2019). We compared pregnancies complicated by maternal infection with either gonorrhea or chlamydia to those without gonorrheal or chlamydial infection, separately. Both analyses included assessment of multiple maternal sociodemographic factors, which were compared between the 2 groups. Multivariable logistic regression was performed to evaluate the association of these factors with gonorrheal or chlamydial infection in pregnancy. RESULTS: Of the 15,341,868 included live births, 45,639 (0.30%) were from patients who had gonorrheal infection, and 282,065 (1.84%) were from patients who had chlamydial infection during pregnancy. Concurrent infection with chlamydia and gonorrhea was associated with the highest risk of gonorrhea and chalmydia in pregnancy (adjusted odds ratio, 26.28; 95% confidence interval, 25.74-26.83, and adjusted odds ratio, 26.03; 95% confidence interval, 25.50-26.58, respectively). Young maternal age, low educational attainment, non-Hispanic Black race/ethnicity, concurrent infection with syphilis, and tobacco use were also associated with a substantial increase in the risk of gonorrheal and chlamydial infection in pregnancy. CONCLUSIONS: Several sociodemographic factors including young maternal age, low educational attainment, Medicaid insurance, and non-Hispanic Black race/ethnicity, are associated with a marked increase in the risk for gonorrheal and chlamydial infection in current US pregnancies. These data may be used to better screen, educate, and treat pregnancies of vulnerable populations at risk for such infections.

Ethical challenges in invasive maternal-fetal intervention.

The field of maternal-fetal intervention is rapidly progressing and with it comes new and often complex ethical considerations that must be addressed. The purpose of this article is to review the ethical issues that arise in maternal-fetal intervention. We will provide two clinical scenarios and discuss the ethical issues related to each scenario and how they were addressed. We will also provide a list of recommended resources that any institutional offering maternal-fetal intervention should have in place to meet the ethical obligations of such work.

The ethics of maternal-fetal surgery.

Maternal-fetal surgery is performed on two patients, the pregnant patient and the fetal patient. Ethics is therefore an essential dimension of maternal-fetal surgery. From its beginnings in only a few centers, various procedures have become available in highly specialized centers in developed countries. Innovation and research have played an indispensable role in the development of maternal-fetal surgery and will continue to do so. In this article we present ethically justified criteria, based on the ethical concept of the fetus as a patient, for clinical innovation and research of maternal-fetal surgery and for the professionally responsible transition from innovation and research into clinical practice. These criteria are designed to be used by clinical innovators, clinical investigators, and by oversight committees.

A survey of honor-related practices among US obstetricians and gynecologists.

OBJECTIVE: To assess patterns of honor-related practices-including virginity testing, virginity restoration, and female genital mutilation (FGM)-among US obstetrician-gynecologists (OBGYNs). METHODS: Between June 1 and August 31, 2016, 1000 members of the American College of Obstetricians and Gynecologists were invited by email to complete an anonymous online survey. The survey comprised 42 questions evaluating the demographic and practice characteristics of the respondents. RESULTS: Overall, 288 of the 909 practicing US OBGYNs with functioning email addresses completed the survey (31.7% response rate). In the 12 months before the survey, 168 (58.3%) respondents had provided care to one or more patients who had previously undergone FGM. Care was also provided for patients who requested virginity testing or virginity restoration by 29 (10.1%) and 16 (5.6%) respondents, respectively. Ten (3.5%) respondents performed virginity testing on request, whereas 3 (1.0%) performed virginity restoration. CONCLUSION: Some respondents performed honor-related practices, which indicated a need to educate all practicing US OBGYNs about their ethical and legal obligations in the care of such patients.

Surgery without consent or miscommunication? A new look at a landmark legal case.

Schloendorff v Society of New York Hospital is regarded widely as a landmark in the history of informed consent because it is thought to have established individual self-determination as the legal basis of consent and respect for patient autonomy as the ethical basis of consent. For a century, it has been understood as a laparotomy done without consent when a pelvic mass was discovered unexpectedly in an anesthetized patient after an examination. We believe it was a case of surgeons failing to communicate properly with each other and their patient. To support this reinterpretation, we present evidence from the original medical and surgical records, letters of key participants in the case, and the trial court record. We also consider the case from the perspective of the modern culture of safety in gynecologic surgery. Contrary to what is commonly assumed, Ms Schloendorff lost her legal case, and her surgery might not have been performed at all had her clinicians known, understood, communicated, documented, and reaffirmed what the patient actually wanted. This new perspective on Schloendorff is important for gynecologic surgeons because it vividly documents the perils of implicit consent, delegating the obtaining of consent, and miscommunication among clinicians. The Schloendorff case underscores the constant need for continuous quality improvement to reduce medical errors and the risk of litigation by improving communication among surgeons.

American Thoracic Society documents: an official American Thoracic Society/Society of Thoracic Radiology Clinical Practice Guideline--Evaluation of Suspected Pulmonary Embolism in Pregnancy.

BACKGROUND: Pulmonary embolism (PE) is a leading cause of maternal mortality in the developed world. Along with appropriate prophylaxis and therapy, prevention of death from PE in pregnancy requires a high index of clinical suspicion followed by a timely and accurate diagnostic approach. METHODS: To provide guidance on this important health issue, a multidisciplinary panel of major medical stakeholders was convened to develop evidence-based guidelines for evaluation of suspected pulmonary embolism in pregnancy using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system. In formulation of the recommended diagnostic algorithm, the important outcomes were defined to be diagnostic accuracy and diagnostic yield; the panel placed a high value on minimizing cumulative radiation dose when determining the recommended sequence of tests. RESULTS: Overall, the quality of the underlying evidence for all recommendations was rated as very low or low with some of the evidence considered for recommendations extrapolated from studies of the general population. Despite the low quality evidence, strong recommendations were made for three specific scenarios: performance of chest radiography (CXR) as the first radiation-associated procedure; use of lung scintigraphy as the preferred test in the setting of a normal CXR; and performance of computed-tomographic pulmonary angiography (CTPA) rather than digital subtraction angiography (DSA) in a pregnant woman with a nondiagnostic ventilation-perfusion (V/Q) result. DISCUSSION: The recommendations presented in this guideline are based upon the currently available evidence; availability of new clinical research data and development and dissemination of new technologies will necessitate a revision and update.

An official American Thoracic Society/Society of Thoracic Radiology clinical practice guideline: evaluation of suspected pulmonary embolism in pregnancy.

BACKGROUND: Pulmonary embolism (PE) is a leading cause of maternal mortality in the developed world. Along with appropriate prophylaxis and therapy, prevention of death from PE in pregnancy requires a high index of clinical suspicion followed by a timely and accurate diagnostic approach. METHODS: To provide guidance on this important health issue, a multidisciplinary panel of major medical stakeholders was convened to develop evidence-based guidelines for evaluation of suspected pulmonary embolism in pregnancy using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system. In formulation of the recommended diagnostic algorithm, the important outcomes were defined to be diagnostic accuracy and diagnostic yield; the panel placed a high value on minimizing cumulative radiation dose when determining the recommended sequence of tests. RESULTS: Overall, the quality of the underlying evidence for all recommendations was rated as very low or low, with some of the evidence considered for recommendations extrapolated from studies of the general population. Despite the low-quality evidence, strong recommendations were made for three specific scenarios: performance of chest radiography (CXR) as the first radiation-associated procedure; use of lung scintigraphy as the preferred test in the setting of a normal CXR; and performance of computed-tomographic pulmonary angiography (CTPA) rather than digital subtraction angiography (DSA) in a pregnant woman with a nondiagnostic ventilation-perfusion (V/Q) result. DISCUSSION: The recommendations presented in this guideline are based upon the currently available evidence; availability of new clinical research data and development and dissemination of new technologies will necessitate a revision and update.

A case study in unethical transgressive bioethics: "Letter of concern from bioethicists" about the prenatal administration of dexamethasone.

On February 3, 2010, a "Letter of Concern from Bioethicists," organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers "mere opinion" as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it.

A new approach to professional liability reform: placing obligations of stakeholders ahead of their interests.

The authors utilize stakeholder theory to provide a new analysis of the professional liability crisis, by identifying the major stakeholders in our current system of professional liability, their respective obligations and self-interests, and how these interests are advanced and constrained by the current system. This stakeholder analysis reveals a core ethical obligation of all stakeholders: the preservation of the integrity of our current judicial system. The adverse impact of the pursuit of stakeholder self-interests, rather than fulfillment of their core, shared ethical obligation, on achievement of the goals of the current system, the deterrence of unsafe practice and compensation of injured patients, is then identified. The authors argue that approaches to reform of professional liability in obstetrics be based upon the common obligation of the stakeholders to fulfill the goals of the system, because attempts to align the myriad self-interests of the stakeholders will be futile.

Ethics of fetal surgery.

This article provides a comprehensive approach to the ethics of clinical investigation of fetal surgery. Investigators should address the initiation and assessment of clinical trials to determine whether they establish a standard of care and use an appropriate informed consent process to recruit and enroll subjects, consider whether selection criteria should include the abortion preferences of the pregnant woman, and consider whether physicians have an obligation to offer referral to such investigation. This approach is comprehensive because it takes account of the physician's obligations to the fetal patient, the pregnant woman, and future fetal and pregnant patients. The comprehensive approach to the ethics of fetal surgery is applied to the example of in utero surgical management of spina bifida.

First-trimester risk assessment for trisomies 21 and 18 in twin pregnancy.

OBJECTIVE: Our objective was to describe performance of first-trimester combined risk assessment in twin pregnancies. STUDY DESIGN: Twin pregnancies that underwent risk assessment in our ultrasound unit from 2003-2006 were included. Adjusted risks for trisomies 21 and 18 that were based on age, nuchal translucency (NT), and biochemistry were provided for each twin. Detection rates for Down syndrome and trisomy 18 were calculated for age/NT, and age/NT/biochemistry at a screen-positive rate of 5% of pregnancies. RESULTS: Five hundred thirty-five pregnancies were included. Median maternal age was 34 years, with 47% of women > or = 35 years old. There were 7 fetuses in 6 dichorionic pregnancies with Down syndrome and 3 fetuses in 3 pregnancies with trisomy 18. For a 5% false-positive rate, age/NT identified 83.3% of Down syndrome and 66.7% of Trisomy 18 pregnancies. Adding biochemistry resulted in 100% detection rates for both conditions. CONCLUSION: The addition of biochemistry may enhance first-trimester risk assessment in twin pregnancies. Further studies with larger numbers of affected pregnancies are needed.

Ethics of maternal-fetal surgery.

The transition from innovation to standard of care for maternal-fetal surgery should be guided by ethical as well as scientific considerations. This chapter provides an ethical framework that identifies criteria for the investigation of maternal-fetal surgery. Using this framework, physicians should address the initiation and assessment of clinical trials to determine whether they establish a standard of care, use an appropriately informed consent process to recruit and enroll subjects, consider whether selection criteria should include the abortion preferences of the pregnant woman, and consider whether physicians have an obligation to offer referral to such investigation. This ethical framework, in a clinically comprehensive fashion, takes account of the physician's obligations to the fetal patient, the pregnant woman, and future fetal and pregnant patients. The ethical framework is illustrated by the example of fetal surgery for spina bifida.

Umbilical cord blood collection: do patients really understand?

BACKGROUND: Pregnant patients have the option of storing their infant's cord blood with a private/commercial company for possible future use by the child or other family members. Some patients also have the option to donate the cord blood to a public bank for anyone to use. We evaluated patient understanding about cord blood banking in a cohort of patients with access to both options. METHODS: Anonymous questionnaires were collected from 325 pregnant patients seen in our Antepartum Testing Unit. RESULTS: Compared to those donating to a public bank, women planning on storing with a private/commercial company were less likely to believe that a suitable donor could be found from a public cord blood bank. Women had a strikingly poor understanding regarding the current uses for cord blood therapy. When asked whether cord blood has been used successfully to treat Alzheimer's disease, Parkinson's disease, and spinal cord injury only 28%, 24%, and 24%, respectively, correctly knew that it had not. CONCLUSIONS: Obstetricians should assume that pregnant women are poorly informed about cord blood banking. The decision making process should be conducted with the goal of ensuring every pregnant woman the opportunity to make a well informed decision about cord blood banking.