Elective delivery at 34 weeks vs routine obstetric care in fetal gastroschisis: randomized controlled trial.

OBJECTIVE: To evaluate whether elective preterm delivery (ED) at 34 weeks is of postnatal benefit to infants with isolated gastroschisis compared with routine obstetric care (RC). METHODS: Between May 2013 and September 2015, all women with a sonographic diagnosis of fetal gastroschisis referred to a single tertiary center, before 34 weeks' gestation, were invited to participate in this study. Eligible patients were randomized to ED (induction of labor at 34 weeks) or RC (spontaneous labor or delivery by 37-38 weeks, based on standard obstetric indications). The primary outcome measure was length of time on total parenteral nutrition (TPN). Secondary outcomes were time to closure of gastroschisis and length of stay in hospital. Outcome variables were compared using appropriate statistical methods. Analysis was based on intention-to-treat. RESULTS: Twenty-five women were assessed for eligibility, of whom 21 (84%; 95% CI, 63.9-95.5%) agreed to participate in the study; of these, 10 were randomized to ED and 11 to RC. The trial was stopped at the first planned interim analysis due to patient safety concerns and for futility; thus, only 21 of the expected 86 patients (24.4%; 95% CI, 15.8-34.9%) were enrolled. Median gestational age at delivery was 34.3 (range, 34-36) weeks in the ED group and 36.7 (range, 27-38) weeks in the RC group. One patient in the ED group delivered at 36 weeks following unsuccessful induction at 34 weeks. Neonates of women who underwent ED, compared to those in the RC group, showed no difference in the median number of days on TPN (54 (range, 17-248) vs 21 (range, 9-465) days; P = 0.08), number of days to closure of gastroschisis (7 (range, 0-15) vs 5 (range, 0-8) days; P = 0.28) and length of stay in hospital (70.5 (range, 22-137) vs 31 (range, 19-186) days; P = 0.15). However, neonates in the ED group were significantly more likely to experience late-onset sepsis compared with those in the RC group (40% (95% CI, 12.2-73.8%) vs 0%; P = 0.03). CONCLUSION: This study demonstrates no benefit of ED of fetuses with gastroschisis when postnatal gastroschisis management is similar to that used in routine care. Rather, the data suggest that ED is detrimental to infants with gastroschisis. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Parto inducido a las 34 semanas versus atención obstétrica rutinaria en la gastrosquisis fetal: ensayo controlado aleatorizado OBJETIVO: Evaluar si el parto pretérmino inducido (PI) a las 34 semanas es beneficioso para los recién nacidos con gastrosquisis aislada en comparación con la atención obstétrica rutinaria (AR). MÉTODOS: Entre mayo de 2013 y septiembre de 2015, se invitó a participar en este estudio a todas las mujeres con diagnóstico ecográfico de gastrosquisis fetal remitidas a un mismo centro terciario, antes de las 34 semanas de gestación. Las pacientes elegibles fueron asignadas al azar al PI (inducción del parto a las 34 semanas) o a la AR (parto espontáneo a las 37-38 semanas, en función de los indicios obstétricos estándar). La medida de resultado primaria fue la duración de la nutrición parenteral total (NPT). Las medidas de resultado secundarias fueron el tiempo hasta el cierre de la gastrosquisis y la duración de la estancia hospitalaria. Las variables de resultado se compararon mediante métodos estadísticos apropiados. El análisis se basó en la intención de tratar. RESULTADOS: Se evaluó la elegibilidad de 25 mujeres, de las cuales 21 (84%; IC 95%, 63,9-95,5%) aceptaron participar en el estudio; de ellas, 10 fueron asignadas al azar al PI y 11 a la AR. El ensayo se detuvo después del primer análisis provisional planificado debido a preocupaciones sobre la seguridad de las pacientes y por su intrascendencia; por lo tanto, sólo se reclutaron 21 de las 86 pacientes esperadas (24,4%; IC 95%, 15,8-34,9%). La mediana de la edad gestacional en el momento del parto fue de 34,3 (rango: 34-36) semanas en el grupo de PI y 36,7 (rango: 27-38) semanas en el grupo de AR. Una paciente del grupo de PI tuvo un parto a las 36 semanas, después de una inducción infructuosa a las 34 semanas. Los neonatos de las mujeres que se sometieron a PI, comparados con los del grupo de AR, no mostraron diferencias en la mediana del número de días de NPT (54 (rango: 17-248) vs 21 (rango: 9-465) días; P=0,08), número de días hasta el cierre de la gastrosquisis (7 (rango: 0-15) vs 5 (rango: 0-8) días; P=0,28) y duración de la estancia hospitalaria (70,5 (rango: 22-137) vs 31 (rango: 19-186) días; P=0,15). Sin embargo, la probabilidad de experimentar sepsis de inicio tardío fue mayor en los neonatos del grupo de PI en comparación el grupo de AR (40% (IC 95%, 12,2-73,8%) vs 0%; P=0,03). CONCLUSIÓN: Este estudio demuestra que el PI no presenta ningún beneficio para los fetos con gastrosquisis cuando el tratamiento de la gastrosquisis postnatal es similar al utilizado en la atención rutinaria. Más bien, los datos sugieren que el PI es perjudicial para los lactantes con gastrosquisis.

Three decades after Baby Doe: how neonatologists and bioethicists conceptualize the Best Interests Standard.

OBJECTIVE: The objective of this study is to determine how neonatologists and bioethicists conceptualize and apply the Best Interests Standard (BIS). STUDY DESIGN: Members of the American Society for Bioethics and Humanities and the American Academy of Pediatrics Section on Neonatal-Perinatal Medicine were surveyed to determine how they conceptualized the BIS and ranked the appropriateness of forgoing life-sustaining therapy (LST). RESULTS: Neonatologists' median response supported an infant-specific BIS conceptualization that linked the infant's and family's interests. They did not support allowing limitations on the family's obligations. Ethicists' supported a conceptualization that linked the infant's and family's interests and limitations on the family's obligations, a less infant-specific conceptualization. Ethicists were less or equally likely to agree with forgoing LST in seven of eight cases. CONCLUSIONS: Ethicists endorsed a conceptualization of the BIS that includes the effects on the family and rejected an infant-specific one. Neonatologists split between these two and rejected limiting the family's obligations. Critical appraisal of the BIS is needed in neonatal ethics.

[Planned non-hospital births in industrialized countries: bureaucratic dream vs. professional responsibility]. / Die geplante Hausgeburt in industrialisierten Ländern: Bürokratische Traumvorstellung vs. professionelle Verantwortlichkeit.

This article addresses in how far planned non-hospital births should be an alternative to planned hospital births. Advocates of planned non-hospital deliveries have emphasised patient safety, patient satisfaction, cost effectiveness, and respect for women's rights. We provide a critical evaluation of each of these claims and have doubts that the information available for the pregnant women and the public is in accord with professional responsibility. We understand that the increasing rates of interventions and operative deliveries in hospital births demand an answer, but we doubt that planned home birth is the appropriate professional solution. Complications during non-hospital births inevitably demand a transport of mother and child to a perinatal centre. The time delay by itself is an unnecessary risk for both and this cannot be abolished by bureaucratic quality criteria as introduced for non-hospital births in Germany. Evidence-based studies have shown that modern knowledge of the course of delivery including ultrasound as well as intensive care during the delivery all reduce the rate of operative deliveries. Unfortunately, this is not well-known and only rarely considered during any delivery. All these facts, however, are the best arguments to find a cooperative model within perinatal centres to combine the art of midwifery with modern science, reduction of pain and perinatal care of the pregnant women before, during and after birth. We therefore call on obstetricians, midwifes and health-care providers as well as health politicians to carefully analyse the studies from Western countries showing increasing risks if the model of intention-to-treat is considered and accoordingly not to support planned non-hospital births nor to include these models into prospective trials. Alternatively, we recommend the introduction of a home-like climate within hospitals and perinatal centres, to avoid unnecessary invasive measures and to really care for the pregnant mother before, during and after delivery within a cooperative model without the lack of patient safety for both mother and child in case of impending or acute emergencies.

Biopsychosocial risks of parental care for high-risk neonates: implications for evidence-based parental counseling.

OBJECTIVE: Provide an evidence base for counseling parents of high-risk neonates about the biopsychosocial impact of providing long-term care. STUDY DESIGN: A review of the effects of long-term care on families of high-risk neonates. Our search was limited to 1993-2010. We used the terms 'long-term care,' 'family,' 'neonate' and 'technology dependence.' Results were organized based on Engel's biopsychosocial model. RESULT: Physical-parental caregivers reported more health problems, had fewer health-promoting behaviors and lower vitality.Psychological-parental caregivers had higher rates of post-traumatic stress disorder and depressive symptoms, although some improved with time. Siblings reported greater stress and depression. Social-parental caregivers achieved fewer years of education, higher unemployment and lower incomes. Couples reported greater family strain. The effect on divorce was mixed. Siblings reported disruption in their academic and social lives. CONCLUSION: Providing long-term care involves biopsychosocial risks. Counseling of parents should identify them and advocate strategies for prevention.

An ethically justified, clinically comprehensive approach to peri-viability: gynaecological, obstetric, perinatal and neonatal dimensions.

Peri-viability, 22-26 completed weeks' gestational age, has generated ongoing clinical ethical controversies concerning the roles of abortion, caesarean delivery for fetal indication, neonatal resuscitation and limits on life-sustaining treatment of neonates. This paper provides a comprehensive, ethically justified approach to the clinical management of peri-viable fetuses and infants. We reviewed available data about the outcomes of peri-viable fetuses and developed an outcomes-based ethical framework that appeals to the ethical principles of beneficence, autonomy and justice. We identified beneficence-based, autonomy-based and justice-based considerations that should guide clinical judgement, the informed consent process, and decisions about termination of pregnancy, caesarean delivery and setting justified limits on life-sustaining treatment of neonatal patients. Ethics is an essential component of perinatal medicine because it provides physicians with an evidence-based, ethically justified, comprehensive approach to the gynaecological, obstetric, perinatal and neonatal dimensions of peri-viability.

John Gregory's medical ethics and the reform of medical practice in eighteenth-century Edinburgh.

John Gregory (1724-73) wrote the first modern, professional medical ethics in the English language, appearing as Lectures on the Duties and Qualifications of a Physician in 1772. This paper examines Gregory's medical ethics as a blend of modern methods of medical science and ethics with premodern ideas. The paper begins by situating Gregory's medical ethics in the context of both private medical practice and the care of patients at the Royal Infirmary of Edinburgh, focusing on the crisis of intellectual and moral trust that prompted Gregory to lecture and write on medical ethics. Drawing on the modern methods of Francis Bacon's philosophy of medicine, and David Hume's science of morals, Gregory bases his medical ethics on the complementary capacities of openness to conviction and sympathy. His moral exemplars of the virtues of candour, steadiness, and tenderness were women of learning and virtue, reflecting the premodern idea of chivalry in the life of service to the sick.

Principles and practice of geriatric assent.

Geriatric assent involves health care professionals' active collaboration with cognitively impaired patients that takes account of their longstanding values in any major health care decisions. The main purpose of this paper is to assist geriatric health practitioners 'in the field' to understand how to apply geriatric assent in a variety of clinical situations to maximize incapacitated older adults' input into decision-making. A case example and algorithm are presented to illustrate the basic principles of implementing geriatric assent. Practice informed by the principles of geriatric assent will preserve respect for the current and future autonomy of patients across diverse cultural backgrounds.