Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome (TTTS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
The purpose of this study is to evaluate the use of diode laser photocoagulation of the communicating vessels in twin-to- twin transfusion syndrome (TTTS) with respect to maternal, fetal and neonatal outcomes.
详细描述
Patients will undergo an intake evaluation followed by a detailed ultrasound examination to rule out the presence of congenital anomalies and to assess the hemodynamic status of the fetuses and any pre-existing cerebral damage. The following data will be collected, as is identical to the standard of care in evaluating monochorionic twins
Maternal
- Age
- Gravidity and parity
- BMI
- Race/ethnicity
- Gestational age
- The presence of any symptoms
- Cervical length
Fetal
- Estimated fetal weight
- Detailed anatomy
- Doppler evaluation of umbilical cord, ductus venosus and middle cerebral arteries
- Evaluation of the myocardial performance indices
- Amniotic fluid volume
- Placental position
- Cord insertions
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Single placenta (Monochorionic)
- •Polyhydramnios present in recipient twin (Greater than 8 cm maximum vertical pocket below 20 weeks and greater than a 10 cm pocket for greater than 20 weeks gestational age)
- •Oligohydramnios present in donor twin (Less than 2 cm maximum vertical pocket)
- •Prominent bladder in the recipient/ non-filling bladder in the donor
- •Thin dividing membrane
排除标准
- •Patients unwilling to participate in the study or to be followed up
- •Presence of major congenital anomalies incompatible with survival
- •Active pre-term labor Ruptured membranes
- •Chorioamnionitis
- •Vaginal bleeding
结局指标
主要结局
Survival
时间窗: Immediately after the surgery to discharge from the hospital after delivery
Survival to discharge from the nursery of affected babies
次要结局
未报告次要终点
研究者
Martin Walker
Co-Director Seattle Childrens Fetal Intervention and Surgery Program, Clinical Assistant Professor
Seattle Children's Hospital