Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.
Division of Pediatric Surgery, Department of Surgery, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.
Ultrasound Obstet Gynecol. 2020 Jan;55(1):15-19. doi: 10.1002/uog.21871. Epub 2019 Dec 3.
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).
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.
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).
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.
评估与常规产科护理（RC）相比，34 周时选择性早产（ED）对单纯先天性腹裂胎儿的产后益处。
2013 年 5 月至 2015 年 9 月，在妊娠 34 周前，所有经超声诊断为胎儿腹裂的孕妇均被邀请参加本研究。符合条件的患者被随机分配到 ED（34 周时引产）或 RC（根据标准产科指征，自发分娩或在 37-38 周分娩）。主要结局指标为全肠外营养（TPN）时间。次要结局是腹裂闭合时间和住院时间。使用适当的统计方法比较结局变量。分析基于意向治疗。
共有 25 名妇女被评估是否符合资格，其中 21 名（84%；95%可信区间，63.9-95.5%）同意参加研究；其中，10 名被随机分配到 ED 组，11 名被随机分配到 RC 组。由于患者安全问题和无效性，该试验在第一次计划的中期分析时停止；因此，仅纳入了预期 86 名患者中的 21 名（24.4%；95%可信区间，15.8-34.9%）。ED 组的中位分娩孕周为 34.3（范围，34-36）周，RC 组为 36.7（范围，27-38）周。ED 组有 1 名患者在 34 周引产失败后于 36 周分娩。与 RC 组相比，接受 ED 的女性新生儿在 TPN 天数中位数（54（范围，17-248）与 21（范围，9-465）天；P=0.08）、腹裂闭合天数中位数（7（范围，0-15）与 5（范围，0-8）天；P=0.28）和住院时间中位数（70.5（范围，22-137）与 31（范围，19-186）天；P=0.15）方面没有差异。然而，ED 组新生儿发生晚发性败血症的可能性明显高于 RC 组（40%（95%可信区间，12.2-73.8%）与 0%；P=0.03）。
本研究表明，当产后腹裂管理与常规护理相似时，胎儿腹裂的 ED 并不能带来益处。相反，数据表明 ED 对腹裂患儿有害。版权所有 © 2019 ISUOG。由 John Wiley & Sons Ltd 出版。
