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.

[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.

Ethical dimensions of ultrasound screening for fetal anomalies.

The ethical dimensions of the debate on routine ultrasound are analyzed. The central role of the informed consent process, based on a respect for the autonomy of the pregnant woman, is presented. Failure to offer quality ultrasound in clinical settings where it is available restricts access to pregnant women to the diagnosis of fetal anomalies and therefore restricts access to the options of abortion and fetal therapy. We show that beneficence- and justice-based considerations do not supersede respect for autonomy.

An ethically justified, clinically comprehensive management strategy for third-trimester pregnancies complicated by fetal anomalies.

We present an ethically justified, clinically comprehensive management strategy for third-trimester pregnancies complicated by fetal anomalies, based on 72 cases diagnosed at a gestational age of more than 24 weeks. These cases are organized into three categories: A) nonaggressive management and termination of pregnancy offered, three of 72 (4%); B) aggressive and nonaggressive management offered, 18 of 72 (25%); and C) aggressive management recommended, 51 of 72 (71%). We then ethically justify a clinically comprehensive management strategy. First, we describe the disclosure requirements of the informed-consent process. Second, we provide an ethical justification for the physician's recommendations among management alternatives. The justification for such recommendations is based on a continuum of beneficence-based obligations to the fetus that is developed in terms of a classification scheme of fetal anomalies, based on the degree of probability of antenatal diagnosis and degree of probability of outcome. When there are no beneficence-based obligations to the fetus, the physician should recommend only termination of pregnancy or nonaggressive management. When there are minimal beneficence-based obligations to the fetus, only aggressive or nonaggressive management should be recommended. Finally, when there are more than minimal beneficence-based obligations to the fetus, only aggressive management should be recommended.

Ethical challenges in the managed practice of obstetrics and gynecology.

Obstetrics and gynecology has been transformed from a fee-for-service, unmanaged system to a prepaid managed system. This change poses significant ethical challenges, which we address. We show that obstetrician-gynecologists and medical institutions are moral co-fiduciaries of female and pregnant patients, that the obstetrician-gynecologist should be economically disciplined without capitulating to managed care, and that managed care organizations have an obligation to support the medical education and research from which they benefit.

Successful external cephalic version in a massively obese patient.

A massively obese patient (199 kg) presented at term with a fetus in the transverse lie. External cephalic version with sonographic guidance was successful, and subsequent vertex vaginal delivery occurred. External cephalic version in the massively obese gravid patient is a therapeutic possibility, and the dangers of cesarean section may be avoided using this procedure.

Perinatal ethics: a practical method of analysis of obligations to mother and fetus.

The ethical principles of beneficence and respect for autonomy enable the physician to identify and consider seriously moral conflicts in modern obstetric care. The authors identify four types of conflicts, provide an analysis of them, and suggest strategies for resolving them in clinical practice.

Ethical analysis of the intrapartum management of pregnancy complicated by fetal hydrocephalus with macrocephaly.

The intrapartum management of pregnancy complicated by fetal hydrocephalus with macrocephaly often confronts the physician with a complex array of moral obligations to both mother and fetus that may sometimes come into direct conflict. The authors analyze the component beneficence-based and autonomy-based obligations of these conflicts and offer strategies for resolving them for each of three clinical subgroups. For isolated fetal hydrocephalus, we argue that cesarean section should be performed except when the woman with full informed consent unwaveringly refuses. For fetal hydrocephalus with severe associated abnormalities (those incompatible with postnatal survival or those characterized by the virtual absence of cognitive function), we propose that cephalocentesis followed by vaginal delivery is permissible. For fetal hydrocephalus with other associated abnormalities, we suggest that the permissibility of cephalocentesis followed by vaginal delivery depends on the degree of severity of the associated abnormalities.

An ethically justified algorithm for offering, recommending, and performing cesarean delivery and its application in managed care practice.

When cesarean delivery is substantively supported and vaginal delivery is not supported in beneficence-based clinical judgment, the physician should offer and recommend only cesarean delivery. When both cesarean and vaginal delivery are substantively supported in beneficence-based clinical judgment, the physician should offer both, discuss any controversy, and make a recommendation. When cesarean delivery is substantively supported and vaginal delivery is more substantively supported in beneficence-based clinical judgment, the physician should offer both and recommend vaginal delivery. If cesarean delivery is not supported and vaginal delivery is substantively supported in beneficence-based clinical judgment, the physician should offer only vaginal delivery. When cesarean delivery is requested and well supported solely in autonomy-based clinical judgment, the physician should repeat the recommendation for vaginal delivery and either perform cesarean delivery or make a referral. Physicians may use this algorithm in negotiating managed care contracts.

Antenatal sonographic diagnosis of single umbilical artery.

Seven fetuses with a single umbilical artery were detected at the perinatal ultrasound unit of Yale University during a one-year period. Other sonographic abnormalities included hydramnios (four cases) and intrauterine growth retardation (two cases). Two neonates died shortly after birth, two others survived with abnormalities, and three were normal. The varied sonographic appearances of single umbilical artery are illustrated and contrasted with sonograms of normal umbilical cords.

An ethical justification for emergency, coerced cesarean delivery.

OBJECTIVE: To provide an ethical justification for emergency coerced cesarean delivery without a court order when a pregnant woman refuses cesarean delivery. METHODS: Ethical analysis is conducted of the existing literature and an ethical justification illustrated by a clinical example. RESULTS: Absolute and near-absolute objections to coerced cesarean delivery fail for lack of adequate arguments to show that the woman's autonomy is not constrained by obligations to the at-term fetal patient. The ethical justification for emergency coerced cesarean delivery requires that three criteria be satisfied: 1) high reliability of the prognostic judgment that on balance cesarean delivery is expected to prevent serious infant morbidity or mortality, 2) lack of physical resistance that could significantly increase the risks of maternal or fetal harm from coerced cesarean delivery, and 3) insufficient time to consider a court order. CONCLUSION: The obstetrician may justifiably coerce emergency cesarean delivery without a court order only when these three criteria are satisfied on a case-by-case basis.

Cesarean delivery for intrapartum fetal heart rate abnormalities: incorporating survey data into clinical judgment.

OBJECTIVE: To identify the descriptive clinical practice of maternal-fetal medicine specialists when faced with severe intrapartum fetal heart rate (FHR) abnormalities (as determined by continuous electronic fetal monitoring). METHODS: All regular members of the Society of Perinatal Obstetricians (maternal-fetal medicine specialists) were sent a survey questionnaire on the topic of cesarean delivery for intrapartum FHR abnormalities. The time from observation of FHR abnormalities to making the decision to proceed to cesarean delivery was the main outcome measure. Time was allowed for intrauterine resuscitative maneuvers to alleviate the abnormal pattern. Legislative definitions of consensus and strong consensus were applied to the data. Analysis of covariance was performed to determine the effect of physician demographic factors on the times reported. RESULTS: Four hundred thirty-one of 704 (61.2%) questionnaires were returned. Consensus was identified for deciding on cesarean delivery (after intrauterine resuscitation) 1) after 30 minutes for cases of repetitive late and severe variable decelerations, 2) after 10 minutes in cases of fetal bradycardia, and 3) in all scenarios with decreased beat-to-beat variability of the FHR. Consensus was identified for deciding on cesarean delivery in five of eight intrapartum FHR pattern abnormalities. CONCLUSION: The descriptive clinical practice of maternal-fetal medicine specialists demonstrated in this study should be considered in prudential clinical judgment.