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.

RESPONDING PROFESSIONALLY TO REQUESTS FOR CESAREAN DELIVERY.

Patients' requests for non-indicated cesarean delivery challenge the professionalism of obstetricians. This is because physicians should not provide clinical management in the absence of an evidence-based indication for it. The ethics of responding professionally to requests for non-indicated cesarean delivery would appear to be simple: just say "No." This paper presents an ethically and clinically more nuanced approach, on the basis of the professional responsibility model of obstetric ethics, emphasizinga preventive ethics approach. Preventive ethics deploys the informed consent process to minimize ethical conflict in clinical practice. This process should focus on when to recommend against cesarean delivery - rather than simply saying no. There is no evidence of net clinical benefit for pregnant, fetal, and neonatal patients from non-indicated cesarean delivery. Obstetricians should therefore respond to such requests by recommending against cesarean delivery, recommending vaginal delivery, and explaining the evidence base for these recommendations.

[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.

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.

Antenatal umbilical coiling index and Doppler flow characteristics.

OBJECTIVE: To evaluate whether a relationship exists between the antenatal umbilical coiling index (UCI) and umbilical cord Doppler flow characteristics. METHODS: During the fetal anatomical survey in 200 consecutive pregnant patients at 18-23 weeks' gestation, we recorded umbilical coiling patterns and blood flow characteristics. The antenatal UCI, calculated as a reciprocal value of the distance between a pair of umbilical cord coils, was compared with Doppler parameters including umbilical vein blood flow volume (in mL/min/kg), and mean resistance index (RI) and peak systolic velocity (PSV in cm/s) averaged from both umbilical arteries. RESULTS: A total of 154 patients met the inclusion criteria of singleton pregnancy and having adequate sonographic umbilical cord images, Doppler flow indices, and all demographic, antenatal and labor data. The mean antenatal UCI was 0.40, with 10th and 90th centiles of 0.20 and 0.60, respectively. The mean +/- SD umbilical artery RI and PSV and umbilical vein blood flow volume were 0.74 +/- 0.07, 25.1 +/- 6.4 cm/s, and 264 +/- 106 mL/min/kg, respectively. All Doppler variables correlated significantly with antenatal UCI, with lower RI and higher PSV and umbilical vein blood flow volume values being associated with higher antenatal UCI (P = 0.016, P < 0.001, and P = 0.032, respectively). However, when stratified by antenatal UCI into hyper- (above 90th centile), normo- (10th-90th centile), and hypocoiled (below 10th centile) umbilical cord groups, a significant difference was observed for PSV only (P = 0.016). CONCLUSION: It appears that umbilical cord coiling modulates noticeably blood flow through the umbilical cord. We speculate that more prominent umbilical coiling (higher antenatal UCI values) has a protective effect on blood flow in terms of decreased arterial resistance and higher blood flow velocities, as well as increased venous blood flow. However, due to lack of significant differences between Doppler characteristics when stratified by antenatal UCI into hypo-, normo-, and hypercoiled groups, the clinical implications of this observation are uncertain.

Intraobserver and interobserver reproducibility of fetal biometry.

OBJECTIVE: To assess the intra- and interobserver reproducibility of ultrasound measurements of fetal biometric parameters. METHODS: We assessed the intraobserver and the interobserver agreement in measurements of fetal biparietal diameter (BPD), abdominal circumference (AC), head circumference (HC) and femur length (FL) on 122 singleton pregnancies. Patients were each examined twice by the first sonographer to determine the intraobserver reliability of measurements of fetal biometry. Subsequently, during the same ultrasound examination, a second blinded sonographer measured fetal biometric parameters to assess interobserver reliability. The consensus between and among observers was analyzed using the intraclass correlation coefficient (intra-CC) and interclass correlation coefficient (inter-CC) and the reliability coefficients (RC, alpha) for the four biometric measurements. A value > 0.75 was considered a reliable consensus for the intra-CC and inter-CC. A Bland and Altman plot was also created for the fetal biometric parameters to assess the repeatability of the measurements. RESULTS: Reliable consensus was observed for both the intra-CC and inter-CC and RC for all four biometric parameters. The intra-CC with the 95% CI and RC for the BPD, AC, HC and FL were as follows: 0.996 (0.995, 0.997), alpha 0.998; 0.994 (0.992, 0.996), alpha 0.997; 0.996 (0.994, 0.997), alpha 0.998; and 0.994 (0.992, 0.996), alpha 0.997, respectively. Similarly, the inter-CC with the 95% CI and RC for the same parameters were as follows: 0.995 (0.993, 0.997), alpha 0.998; 0.980 (0.971, 0.990), alpha 0.990; 0.994 (0.992, 0.996), alpha 0.997; and 0.990 (0.985,0.993), alpha 0.995, respectively. The Bland and Altman plots demonstrated a high degree of repeatability of BPD, AC, HC, and FL measurements. CONCLUSION: Our results demonstrate that the intra- and interobserver reproducibility of ultrasound measurements of fetal biometry are highly reliable.