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.

胃切西斯是最常见的先天性腹壁缺陷，在该缺陷中，肠道将胎儿外的遗传性归因于羊水。妊娠14周后，它通过产前超声诊断。每4000个出生中，大约有1个受胃chisis的影响，并且发病率正在增加。由于肠道损害或损失，患者的子集具有复杂的课程。这可能是由于椎间盘突出症暴露于羊水的腐蚀性作用或腹壁缺陷的狭窄，从而限制了肠血供应。此外，胃刺激患者患有少聚糖的风险增加（减少羊水体积），胎儿生长滞后和死产。三个月后期，胎儿灭亡（死产）或肠道损害的风险促使一些提供者早日提供胃胃患者。这可能导致与早产相关的发病率的风险增加。目前，关于以胃刺激和全国练习模式分娩的理想时机尚无共识。目前尚不清楚哪个为胎儿提供了更好的结果的机会 - 早期分娩以减轻危害和肠道伤害的风险，而不是接近期限。回顾性数据发布的结果表明，与胃肠道相比，早期与后来的妊娠年龄交付不一致。仅尝试了两个随机的单一机构的前瞻性试验，这些试验与自发性劳动进行了选举的早产。第一次试验包括42名渲染研究不足的患者。据报道，虽然报告了降低长度的趋势，并报告了早期分娩组的较早喂养时间，但结果尚未达到统计学意义。由于对徒劳的担忧和34周分娩组的败血症率，第二次试验被停止了。在初始试验和其他已发表的前瞻性数据中，在早期组中没有看到较高的败血症。由于缺乏高质量的证据，胃chisisis的交付时间在妊娠年龄和监测之间在全国范围内有所不同，直到自发分娩为止，这可能长达40周。由于可用的最佳证据不能充分回答最佳胎龄的分娩时代的问题，因此这项比较有效性研究的目的是调查以下假设：在稳定的胃口稳定患者中，稳定的胃口患者在35周内的交付优于观察和预期管理，其目的是在38周时交付。为了检验这一假设，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与研究，并将在33周内随机分配以在35或38周时分娩。主要的综合结果将包括宫内胎儿的灭亡，出院前的新生儿死亡，呼吸发病率，胃肠道发病率和脓毒症。孕产妇，胎儿和新生儿次要结局也将进行研究。这项研究有可能最终确定对胃肠道的婴儿和分娩母亲的最佳治疗方法。