Gastroschisis Outcomes of Delivery (GOOD) Study

腹裂分娩结果 (GOOD) 研究

基本信息

批准号：
10392502
负责人：
Anthony Johnson
金额：
$ 90.98万
依托单位：
MEDICAL COLLEGE OF WISCONSIN
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-13 至 2026-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10392502
关键词：
Abdomen Affect American Amniotic Fluid Birth Blood Blood Transfusion Caffeine Caring Case Management Catheters Caustics Centers for Disease Control and Prevention (U.S.)Cesarean section Clinical Data Clinical Trials Cognitive Conflict (Psychology)Consensus Data Databases Defect Development Diagnosis Enrollment Ensure Enteral Event Exposure to Fetal Death Fetal Growth Fetal Weight Fetus Foundations Futility Future Gastroschisis Gestational Age Goals High-Risk Pregnancy Iatrogenesis Incidence Individual Induced Labor Infant Infection Infrastructure Injury Institution Intestinal Atresia Intestines Length of Stay Live Birth Meta-Analysis Monitor Morbidity - disease rate Mothers Motor Necrotizing Enterocolitis Neonatal Neonatal Intensive Care Units Oligohydramnios Outcome Parenteral Nutrition Participant Patients Pattern Pregnancy Pregnant Women Premature Birth Prenatal Diagnosis Prolonged Pregnancy Provider Publishing Quality of life Randomized Registries Reporting Research Research Design Resources Retrospective Studies Risk Sepsis Testing Third Pregnancy Trimester Time United States Vascular blood supply Venous Weight Woman abdominal wall adverse outcome antenatal arm base biobank cohort comparative effectiveness study comparative effectiveness trial delivery complications evidence based guidelines feeding fetal fetus surgery gastrointestinal improved outcome indexing infant death infant morbidity intestinal injury mortality risk neonatal death neonatal outcome optimal treatments patient subsets premature prenatal therapy primary outcome prospective public health research randomized trial respiratory respiratory morbidity secondary outcome stillbirth trend trial design ultrasound

项目摘要

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.

腹裂是最常见的先天性腹壁缺陷，其中肠道在胎儿体外突出进入羊水。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 人患有腹裂，而且发病率正在增加。由于肠道损伤或丧失，部分患者的病程较为复杂。这可能是由于突出的肠道暴露于羊水的腐蚀性作用或腹壁缺损变窄限制了肠道血液供应。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接生腹裂患者。这可能会导致早产相关发病的风险增加。目前，对于腹裂婴儿的理想分娩时间尚未达成共识，而且各国的实践模式差异很大。目前尚不清楚哪种方式可以为胎儿带来更好的结果——提前分娩以降低死亡和肠道损伤的风险，还是接近足月分娩。发表的回顾性数据显示，腹裂中早孕与晚孕的结果不一致。仅尝试了两项关于选择性早产与等待自然分娩的随机、单一机构、前瞻性试验。第一项试验纳入了 42 名患者，这使得该研究的效果显着不足。虽然据报道，早期分娩组存在住院时间缩短和完全喂养时间提前的趋势，但结果并未达到统计学显着性。由于担心 34 周分娩组的无效性和败血症发生率，第二项试验在招募 21 名患者后停止。在最初的试验和其他已发表的前瞻性数据中，早期组中并未发现败血症发生率较高。由于缺乏高质量证据，腹裂的分娩时间在全国范围内各不相同，从孕周 34 周开始监测直至自然分娩，最长可达 40 周。由于现有的最佳证据并不能充分回答最佳分娩孕龄的问题，这项比较有效性研究的目的是调查以下假设：稳定的腹裂患者在 35 周时分娩优于观察和期待治疗，目标是38周时分娩。为了检验这一假设，我们将完成一项随机、前瞻性、多机构试验。患者可以在 33 周之前的任何时间参加该研究，并在 33 周时被随机分配到 35 周或 38 周时分娩。主要复合结局包括胎儿宫内死亡、出院前新生儿死亡、呼吸道疾病、胃肠道疾病和败血症。还将调查孕产妇、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母亲的最佳治疗方法。