A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 22
- 主要终点
- Survival of donor twin at 30 days after birth and no treatment failure
研究概览
简要总结
This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.
详细描述
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 twin-twin transfusion syndrome (TTTS). We propose to test this hypothesis by a prospective randomized multicenter trial to compare serial amnioreduction with selective fetoscopic laser photocoagulation in cases of severe (stage II-IV) twin-twin transfusion syndrome (TTTS). Primary Outcomes: Survival of donor twin at 30 days after birth and no treatment failure; Survival of recipient twin at 30 days after birth and no treatment failure; Secondary Outcomes: Survival times of each twin in utero or after birth (which may be censored at 30 days after birth); Gestational age at delivery; Placental insufficiency; Cardiac outcome: echocardiographic evidence of cardiac compromise; Neurologic outcome: evidence of brain injury preceding birth by MRI; Postnatal comorbidity
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Both twins are alive
- •TTTS diagnosed prior to 22 weeks gestation
- •Monochorionic diamniotic gestation
- •Like sex twins
- •Single placental mass
- •Thin intertwin membrane
- •Oligohydramnios in donor twin (deepest vertical pocket of ≤ 2 cm)
- •Polyhydramnios with deepest vertical pocket of > 8 cm with or without Doppler or echocardiographic changes in the recipient twin (deepest vertical pocket of > 6 cm if previous amnioreduction)
- •Decompressed bladder in donor not seen to fill during the ultrasound examination (stage II, III, or IV), unless Doppler velocimetry changes (absent end-diastolic umbilical artery flow, abnormal ductus venosus waveform), and/or echocardiographic changes (valvular insufficiency, ventricular hypertrophy) are already present
- •No associated structural abnormalities
- •No sonographic evidence of CNS injury at time of entry
- •No preterm labor
- •No maternal medical contraindication to anesthesia or surgery
排除标准
- •Failure to meet all inclusion criteria
- •TTTS presenting after 22 weeks gestation
- •Randomization after 24 weeks gestation
- •Cervical length < 2.0 cm post initial
- •Presence of cervical cerclage
- •Uterine anomaly
- •Refusal to accept randomization
- •Unable to pursue prenatal care at an approved center coordinated by one of the participating institutions
- •Unable to pursue postnatal evaluation at a NICHD Neonatal Research Network Institution
结局指标
主要结局
Survival of donor twin at 30 days after birth and no treatment failure
Survival of recipient twin at 30 days after birth and no treatment failure
次要结局
- Survival times of each twin in utero or after birth (which may be censored at 30 days after birth)
- Gestational age at delivery
- Placental insufficiency
- Cardiac outcome: echocardiographic evidence of cardiac compromise
- Neurologic outcome: evidence of brain injury preceding birth by MRI
- Postnatal comorbidity