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临床试验/NCT01622049
NCT01622049已完成不适用

Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome

University of South Florida1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
The primary study objective is to evaluate neonatal/infant survival 6 months after birth.

研究概览

简要总结

Patients undergo a detailed ultrasound examination to rule out the presence of congenital anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS will be considered candidates for the trial. Patients will be counseled about the risks and benefits of all treatment options and will be free to choose any treatment option. They will then be asked to sign an informed consent. The procedure will be performed under local anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. An accessory port may be required in some cases. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted often during the procedure. An amniodrainage of the larger sac may be performed at the time of the procedure. The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on the first post operative day. Patients will undergo a weekly ultrasound examination for four weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders, absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein, ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive care unit will be followed through their discharge. Evidence of neurological or cardiac morbidity will be sought in each twin. If either of these complications is suspected, evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be followed up for neonatal, infant and childhood morbidity or mortality. It is requested that all placentas be delivered fresh to Tampa General Hospital in an icebox container for assessment. Placentas will be discarded after analysis.

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The primary study objective is to evaluate neonatal/infant survival 6 months after birth.

时间窗: 6 months

次要结局

  • The secondary study objective is to evaluate the effects of surgery on postnatal neurological morbidity. For the purposes of this clinical trial, neurological morbidity includes any of the following conditions diagnosed within 6 months of birth(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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