Gastroschisis Outcomes of Delivery (GOOD) Study

腹裂分娩结果 (GOOD) 研究

• 批准号: 10611305
• 负责人: Anthony Johnson
• 金额: $ 95.07万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 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/10611305
• 关键词: Abdomen; Affect; American; Amniotic Fluid; Birth; Blood; Blood Transfusion; Caffeine; Caring; Case Management; Catheters; Caustics; Cesarean section; Clinical Data; Clinical Trials; Cognitive; Consensus; Data; Databases; Defect; Development; Diagnosis; Enrollment; Ensure; Enteral; Event; Expectancy; 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; Pregnancy Complications; Pregnant Women; Premature Birth; Prenatal Diagnosis; Prolonged Pregnancy; Provider; Publishing; Quality of life; Randomized; Recommendation; Registries; Reporting; Research; Research Design; Resources; Retrospective Studies; Risk; Sepsis; Specialized Center; Testing; Third Pregnancy Trimester; Time; United States; Vascular blood supply; Venous; Weight; Woman; abdominal wall; adverse outcome; antenatal; arm; biobank; cohort; comparative effectiveness study; comparative effectiveness trial; constriction; 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; risk mitigation; secondary outcome; stillbirth; trend; trial design; ultrasound

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损，其表现为肠疝出胎儿，进入羊水中。妊娠14周后通过产前超声诊断。大约每4000个新生儿中就有1个受到胃裂的影响，而且发病率正在增加。部分患者由于肠的损伤或丧失而出现复杂的病程。这可能是由于疝出的肠子暴露在羊水的腐蚀作用下，或者是由于腹壁狭窄缺陷收缩了肠血供。此外，胃裂患者羊水过少（羊水体积减少）、胎儿生长滞后和死产的风险增加。由于妊娠晚期胎儿死亡（死产）或肠道损伤的风险，一些提供者提前为胃裂患者接生。这可能导致早产相关疾病的风险增加。目前，关于腹裂婴儿的理想分娩时间尚无共识，各国的实践模式差异很大。目前尚不清楚哪种方式能给胎儿带来更好的结局——早期分娩以减轻死亡和肠道损伤的风险，还是临近足月分娩。发表的回顾性数据显示，胃裂早期分娩与晚期分娩的结果不一致。只有两个随机，单一机构，选择性早产与等待自然分娩的前瞻性试验进行了尝试。第一次试验包括42名患者，这使得这项研究在很大程度上缺乏动力。虽然早分娩组有住院时间缩短和提前完全喂养的趋势，但结果没有达到统计学意义。第二次试验在21名患者入组后停止，因为考虑到34周分娩组的无效和脓毒症发生率。在初始试验和其他已发表的前瞻性数据中，早期组未见较高的败血症发生率。由于缺乏高质量的证据，胃裂的分娩时间在全国范围内各不相同，从孕34周到监测到自然分娩，自然分娩可能长达40周。由于现有的最佳证据并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探讨稳定胃裂患者在35周分娩优于以38周分娩为目标的观察和期待治疗的假设。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周之前的任何时间入组研究，并将在33周时随机分配到35周或38周分娩。主要综合结局包括宫内胎儿死亡、新生儿出院前死亡、呼吸道疾病、胃肠道疾病和败血症。孕产妇、胎儿和新生儿的次要结局也将被调查。这项研究有可能最终确定腹裂婴儿和分娩他们的母亲的最佳治疗方法。