NCT02122328已完成不适用
USFetus Randomized Clinical Trial: Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 642
- 试验地点
- 2
- 主要终点
- To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.
研究概览
简要总结
The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant method, selective laser photocoagulation of communicating vessels (SLPCV), may provide vascular stability to the donor fetus. The primary objective is to evaluate the perinatal outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a prospective, randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.
- •Confirmed TTTS patients, who by definition meet the following sonographic criteria:
- •Single placenta.
- •Polyhydramnios: maximum vertical pocket ≥ 8 cm in the recipient twin, prior to amniodrainage.
- •Oligohydramnios: maximum vertical pocket ≤ 2 cm in the donor twin, prior to amniodrainage.
- •Thin dividing membrane (absence of twin peak sign) or absence of dividing membrane (monoamniotic).
- •Same gender, if visible.
- •Quintero Stages 1-
- •Patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included.
- •Patients with an anterior placenta may be included.
- •Triplet gestations with two or three fetuses sharing the same placenta may be included.
- •Patients must be able to give written informed consent.
排除标准
- •Patients unable or unwilling to participate in the study or to be followed up.
- •Patients unable to give written informed consent.
- •Presence of major congenital anomalies that may not warrant surgery.
- •Known unbalanced chromosomal complement.
- •Prior intentional septostomy (purposely making a hole in the dividing membrane).
- •Ruptured membranes.
- •Chorioamnionitis.
- •Abnormal intracranial ultrasound findings of either fetus to include, but not limited to: intraventricular hemorrhage, porencephalic cysts, hydrocephalus, Dandy-Walker syndrome, holoprosencephaly and agenesis of the corpus callosum. Isolated ventriculomegaly (atrium 10-19 mm) may or may not be used as exclusion criteria.
- •Placental abruption.
- •Active labor.
- •Patient unwilling to receive blood products.
- •Recipient twin with a middle cerebral artery peak systolic velocity > 1.5 multiples of the median (indicative of fetal anemia).
- •Any other patient deemed inappropriate for the study by the principal investigator.
结局指标
主要结局
To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.
时间窗: Birth
A comparison of donor survival at birth will be made between subjects assigned to the sequential (SQLPCV) procedure versus those assigned to the selective (SLPCV) procedure.
次要结局
- Surgical complications(21 post-operative days)
研究者
Ramen Chmait
Associate Professor, Clinical Obstetrics & Gynecology, Pediatrics, and Surgery
University of Southern California
研究点 (2)
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