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(申请人提供)：双胞胎输血综合征 TTTS是单绒毛膜双胎最常见的严重并发症 妊娠，分别影响4%至35%的单绒毛膜双胎妊娠 在美国的一年。TTTS占围产儿总数的17% 与双胞胎妊娠相关的死亡率。美国的标准疗法 各州一直仅限于连续羊水排出，这似乎可以改善 总体结果，但对更严重的结束几乎没有影响 TTTS中的光谱。此外，TTTS的幸存者接受了连续治疗 羊水减少有18%到26%的显著神经学和 心脏发病率。选择性胎儿内窥镜激光光凝术 绒毛膜血管迷走症已成为TTTS的一种替代治疗策略 与连续羊水减少术相比，非随机、非 前瞻性临床研究。胎儿镜下激光治疗子宫肌瘤的优越性 TTTS仍未得到证实。在我们的初步数据中，我们观察到 选择性胎儿镜下激光光凝治疗妊娠合并胆囊癌 已连续羊水减少术或显微中隔吻合术失败的TTTS。我们 假设通过选择性地治疗潜在的脉络膜血管闭塞 胎儿镜下激光光凝不仅可以提高双胞胎的存活率 但会降低神经、心脏和发育障碍的发生率 TTTS的后遗症。我们建议通过一个预期来检验这一假设 随机多中心试验比较连续羊膜促排卵与选择性羊膜促排卵 胎儿镜下激光光凝术。在……里面。在本研究的过程中，我们将 解决以下具体目标：1)证明选择性激光 重度TETS患者脉络膜血管疏松的光凝治疗效果显著 与侵袭性连续羊水减胎术相比，双胞胎存活率提高 心理治疗。受者和捐赠者的存活率，在同一怀孕期间和 出生后30天内的总存活率将进行检查；2)证明 选择性激光光凝显著改善了 重度TTTS幸存者的心脏、神经和发育结局 与接受积极的连续羊水减少术的幸存者相比。这将是 是一项多中心前瞻性随机临床试验 在16个参与中心中的一个随机进行连续羊水引产 或在一个或两个参与中心进行选择性胎儿激光手术。这个 胎儿超声心动图将以盲法检查，以评估 心脏发病率和对治疗的反应。同样，产前超声波， S在出生后第一周和之后进行了超声波和核磁共振检查 4周后，将进行盲法复查，以评估神经学 发病率和区分产前和围产期事件。长期的 神经发育结果将由NIGH])新生儿网络在 18至22个月龄。这项研究的总体目标是改善 通过确定TTTS的哪种治疗方法对双胞胎TTTS的转归 更好的生存以及心脏、神经和发育结果。