Gastroschisis Outcomes of Delivery (GOOD) Study

腹裂是一种最常见的先天性腹壁缺陷，其特点是肠管在胎儿外进入羊水内。妊娠14周后进行产前超声诊断。大约每4000名新生儿中就有一名受到腹裂的影响，而且发病率还在增加。部分患者由于肠道损伤或丢失而有复杂的病程。这可能是由于突出的肠道暴露在羊水的腐蚀性影响下，或由于腹壁狭窄，限制了肠道的血液供应。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提供者提前交付腹裂患者。这可能会增加早产相关发病率的风险。目前，对于腹裂婴儿的理想分娩时间还没有达成共识，各国的做法模式也存在很大差异。目前尚不清楚哪种方式为胎儿提供了更好的结局--早期分娩与临近足月分娩相比，可以减少死亡和肠道损伤的风险。发表的回顾数据显示，腹裂的早产和晚产的结果不一致。只有两个随机、单一机构的前瞻性试验被尝试，分别是选择性早产和等待自然分娩。第一次试验包括42名患者，使这项研究在很大程度上动力不足。虽然早产组有减少住院时间和提前完全喂养的趋势，但结果没有达到统计学意义。第二项试验在21名患者入选后停止，原因是担心无效和34周分娩组的败血症发生率。在最初的试验和其他已发表的前瞻性数据中，早期组没有看到更高的脓毒症发生率。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，从妊娠34周到自然分娩，可能长达40周。由于现有最好的证据不能充分回答最佳分娩孕龄的问题，本比较有效性研究的目的是调查腹裂稳定期患者在35周分娩优于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、多机构的试验。患者可以在33周之前的任何时间参加这项研究，并将在33周随机分为35周或38周分娩。主要的综合结果将包括胎儿宫内死亡、出院前新生儿死亡、呼吸道并发症、胃肠道并发症和败血症。孕妇、胎儿和新生儿的二次结局也将被调查。这项研究有可能最终确定腹裂婴儿和分娩母亲的最佳治疗方案。

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.