Gastroschisis Outcomes of Delivery (GOOD) Study

腹裂是最常见的先天性腹壁缺陷，其中肠疝出胎儿进入羊水。妊娠14周后通过产前超声诊断。大约每4000名新生儿中就有1人受到腹裂的影响，而且发病率正在上升。部分患者由于肠道损伤或丧失而具有复杂的病程。这可能是由于疝出的肠暴露于羊水的腐蚀性作用或腹壁缺损的狭窄限制了肠血供。此外，腹裂患者发生羊水过少（羊水量减少）、胎儿生长迟缓和死产的风险增加。妊娠晚期胎儿死亡（死产）或肠道损伤的风险促使一些供应商提前交付腹裂患者。这可能导致早产相关发病率的风险增加。目前，关于腹裂婴儿分娩的理想时间还没有达成共识，各国的实践模式差异很大。目前还不清楚哪一种能给胎儿带来更好的结局--早期分娩以降低死亡和肠道损伤的风险，而不是接近足月分娩。发表的回顾性数据显示，腹裂的早胎龄分娩与晚胎龄分娩的结果不一致。只有两个随机的，单一的机构，前瞻性试验选择性早产与等待自然分娩已经尝试。第一项试验包括42名患者，使研究在很大程度上动力不足。虽然报告了早产组住院时间缩短和提前至完全喂养时间的趋势，但结果未达到统计学显著性。第二项试验在21名患者入组后停止，因为担心34周分娩组的无效性和败血症发生率。在最初的试验和其他发表的前瞻性数据中，早期组的败血症发生率并不高。由于缺乏高质量的证据，腹裂的分娩时间在全国范围内各不相同，从胎龄34周到监测到自然分娩，可能长达40周。由于现有的最佳证据不能充分回答最佳分娩胎龄的问题，本比较有效性研究的目的是调查稳定腹裂患者在35周分娩上级观察和期待治疗的假设，目标是在38周分娩。为了验证这一假设，我们将完成一项随机、前瞻性、多机构试验。患者可在33周前的任何时间入组研究，并将在33周时随机分配至35周或38周时分娩。主要复合结局将包括宫内胎儿死亡、新生儿出院前死亡、呼吸系统发病率、胃肠道发病率和败血症。还将研究母体、胎儿和新生儿的次要结局。这项研究有可能最终确定腹裂婴儿和分娩他们的母亲的最佳治疗方法。

Gastroschisis is the most common congenital abdominal wall defect in which the intestines herniate outside the fetus into the amniotic fluid. It is diagnosed by prenatal ultrasound after 14 weeks gestation. Approximately 1 out of every 4000 births is affected by gastroschisis, and the incidence is increasing. Subsets of patients have complicated courses due to damage or loss of intestine. This may be due to exposure of the herniated intestines to the caustic effects of amniotic fluid or the narrowing of the abdominal wall defect constricting the intestinal blood supply. Additionally, gastroschisis patients have an increased risk of developing oligohydramnios (reduced amniotic fluid volume), fetal growth lag and stillbirth. The risk of fetal demise (stillbirth) or intestinal damage late in the third trimester has prompted some providers to deliver gastroschisis patients early. This may result in an increased risk of prematurity-related morbidity. Currently, no consensus exists about the ideal time to deliver a baby with gastroschisis and nationally practice patterns vary widely. It is unclear which offers the fetus a chance at a better outcome - early delivery to mitigate risk of demise and intestinal injury versus delivery closer to term. Retrospective data published show inconsistent results with early versus later gestational age delivery in gastroschisis. Only two randomized, single institution, prospective trials with elective preterm delivery versus awaiting spontaneous labor have been attempted. The first trial included 42 patients rendering the study largely underpowered. While a trend towards decreased length of stay and earlier time to full feeding in the early delivery group was reported, the results did not reach statistical significance. The second trial was stopped after 21 patients were enrolled because of concerns of futility and the rate of sepsis in the 34 week delivery group. A higher rate of sepsis was not seen in the early group in the initial trial and in other published prospective data. Due to the paucity of high-quality evidence, delivery timing for gastroschisis varies nationally between 34 weeks gestational age and monitoring until spontaneous delivery, which could be up to 40 weeks. As the best evidence available does not adequately answer the question of optimal gestational age of delivery, the objective of this comparative effectiveness study is to investigate the hypothesis that delivery at 35 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial. Patients may be enrolled in the study any time prior to 33 weeks and will be randomized at 33 weeks to either delivery at 35 or 38 weeks. The primary composite outcome will include intrauterine fetal demise, neonatal death prior to discharge, respiratory morbidity, gastrointestinal morbidity, and sepsis. Maternal, fetal, and neonatal secondary outcomes will also be investigated. This study has the potential to finally determine the optimal treatment for babies with gastroschisis and the mothers who deliver them.