Twin-Twin Transfusion Syndrome Trial

双胎输血综合症试验

• 批准号: 6948734
• 负责人: TIMOTHY M CROMBLEHOLME
• 金额: $ 105.41万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-24 至 2006-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6948734
• 关键词: amniotic fluid; body fluid balance therapy; clinical trials; echocardiography; embryo /fetus therapy; human pregnant subject; human subject; human therapy evaluation; magnetic resonance imaging; patient oriented research; photocoagulation therapy; placenta disorders; twin /multiplet; ultrasonography

DESCRIPTION (provided by applicant): The twin twin transfusion syndrome (TTTS) is the most common serious complication of monochorionic twin gestations, affecting between 4 and 35% of monochorionic twin pregnancies each year in the United States. The TTTS accounts for 17% of all perinatal mortality associated with twin gestations. Standard therapy in the United States has been limited to serial amnioreduction which appears to improve the overall outcome but has had little impact on the more severe end of the spectrum in TTTS. In addition, survivors of TTTS treated by serial amnioreduction have an 18 to 26% incidence of significant neurologic and cardiac morbidity. Selective fetoscopic laser photocoagulation of chorioangiopagus has emerged as an alternative treatment strategy in TTTS with comparable survival to serial amnioreduction in non-randomized, non- prospective clinical studies. The superiority of fetoscopic laser treatment of TTTS remains unproven. In our preliminary data we have observed enhanced survival with selective fetoscopic laser photocoagulation in pregnancies with TTTS that had already failed serial amnioreduction or rnicroseptostomy. We hypothesize that treatment of the underlying chorioangiopagus by selective fetoscopic laser photocoagulation will not only improve the survival of twins but will reduce the incidence of neurologic, cardiac, and developmental sequelae of TTTS. We propose to test this hypothesis by a prospective randomized multicenter trial to compare serial amnioreduction with selective fetoscopic laser photocoagulation. In. the course of this study we will address the following specific aims: 1) To demonstrate that selective laser photocoagulation of chorioangiopagus in severe tETS results in significantly improved survival of twins compared to aggressive serial amnioreduction therapy. Survival of recipients and donors, both within the same pregnancy and overall survival to 30 days after birth will be examined; 2) To demonstrate that selective laser photocoagulation results in significantly improved cardiac, neurologic, and developmental outcomes in survivors of severe TTTS compared to survivors treated by aggressive serial amnioreduction. This will be a multicenter prospective randomized clinical trial with patients randomized either to serial amnioreduction at one of 16 participating centers or selective fetoscopic laser surgery at one or two participating centers. The fetal echocardiograms will be reviewed in a blinded fashion to evaluate cardiac morbidity and response to treatment.. Similarly, prenatal ultrasounds, as well as ultrasounds and MRI s obtained in the first week of life and after 4 weeks, will be reviewed in a blinded fashion to evaluate the neurologic morbidity and distinguish prenatal from perinatal events. Long-term neurodevelopmental outcome will be evaluated by the NIGH]) Neonatal Network at 18 to 22 months of age. The overall goal of the study is to improve the outcomes of twins with TTTS by determining which treatment for TTTS has a better survival as well as cardiac, neurologic, and developmental outcome.

描述（由申请人提供）：双胞胎输血综合症 （TTTS）是单chorionic双胞胎最常见的严重并发症 妊娠，影响4％至35％的单chorionic双胞胎怀孕 在美国。 TTTS占所有围产期的17％ 与双胞胎妊娠有关的死亡率。曼联的标准疗法 各州仅限于连续羊膜填积，这似乎改善了 总体结果，但对更严重的末端影响很小 ttts中的频谱。此外，由串行处理的TTT的幸存者 羊膜填充物的神经系统发病率为18％至26％， 心脏发病率。选择性胎儿镜激光光凝 在TTTS中，合唱团已成为一种替代治疗策略 在非随机，非 - 前瞻性临床研究。胎儿镜激光治疗的优势 TTTS仍然未经证实。在我们的初步数据中，我们观察到了增强 与选择性胎儿镜激光光凝生存 已经失败的连续羊膜症或r氏造口术失败的TTT。我们 假设通过选择性治疗基础绒毛膜血管 胎儿镜激光光凝不仅可以提高双胞胎的存活率 但会降低神经，心脏和发育的发生率 TTTS的后遗症。我们建议通过前瞻性检验这一假设 随机多中心试验，以比较串行羊有选择性与选择性 胎儿镜激光光凝。在。这项研究的过程我们将 解决以下特定目的：1）证明选择性激光器 严重TET中绒毛膜血管的光凝显着导致 与侵略性的连环羊膜化相比，双胞胎的存活率提高了 治疗。在同一怀孕和 将检查到出生后30天的总生存期； 2）演示 选择性激光光凝可显着改善 严重TTT的幸存者的心脏，神经系统和发展结果 与通过侵略性连环羊膜化治疗的幸存者相比。这会 成为患者的多中心前瞻性随机临床试验 在16个参与中心之一的一个随机分配到连续羊膜化 或在一个或两个参与中心的选择性胎儿镜激光手术。这 胎儿超声心动图将以盲目的方式进行审查以评估 心脏发病率和对治疗的反应。同样，产前超声， 以及在生命的第一周和之后获得的超声波和MRI 4周，将以盲目的方式进行审查以评估神经系统 发病率并区分产前事件。长期 神经发育结果将通过附近的新生儿网络评估 18至22个月大。该研究的总体目标是改善 通过确定哪种TTT治疗的TTT的双胞胎的结果具有 更好的生存以及心脏，神经系统和发育结果。