Randomized Controlled Trial of Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Perinatal survival rate
研究概览
简要总结
There are two options of fetal treatment in cases of severe lower urinary tract obstructions: the vesico-amniotic shunting and fetal cystoscopy. There is no study confirming the effectiveness of these treatment, specially comparing both techniques. The present study aims to investigate the effectiveness of these treatments.
详细描述
Objectives: To evaluate the effectiveness of fetal cystoscopy for the diagnosis and therapy of the posterior urethral valves and to compare with the results of vesicoamniotic shunting.
Outcomes: Accuracy of the prenatal cystoscopic diagnosis of posterior urethral valves, neonatal and infant survival (6 and 12 months), as well as normal renal function during the same ages.
Study design: Randomized controlled trial. Methods: Pregnant women whose fetuses have isolated and severe lower urinary tract obstruction (LUTO) with (oligohydramnios and severe hydronephrosis) will be invited to participate in the present study. Patients will be randomized into the fetal cystoscopic group (CYSTO) vs vesico-amniotic shunting (VAS). The investigators intend to enroll 30 patients in each group (a total of 60). All patients will be followed by fetal ultrasound each 15 days. Besides, these infants will be followed up to one year of age. Maternal and obstetrical complications are going to be evaluated as well as neonatal and infant survival and the renal function.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •single pregnancy
- •male fetuses
- •gestational age dating by ultrasound examination performed before 20 weeks
- •confirmed severe LUTO (see details before)
- •severe oligohydramnios (AFI<5.0cm)
- •no other structural anomalies by complete fetal anatomy ultrasound scan and fetal echocardiogram
- •no abnormal karyotype
- •'favorable' urine analysis (urinary sodium <100 mEq/L, chloride <90 mEq/L, osmolarity <200 mOsm/L) when gestational age >20 weeks
排除标准
- •presence of other anomalies diagnosed after fetal intervention
- •maternal refusal to participate in the present protocol
结局指标
主要结局
Perinatal survival rate
时间窗: from fetal period to neonatal perid (up to 28 days after birth)
The primary outcome is survival from the treatment to the neonatal period (up to 28 days of life). Therefore, the objective is to evaluate the safety and effectiveness of both therapeutic options.
Neonatal renal function
时间窗: up to 28 days of life
Renal function will be evaluated by serum creatine and urinalysis in the neonates, as well as by micturating cystourethrography and postnatal cystoscopy after birth up to 28 days of life.
次要结局
- Survival rate at 1 year of age(1 year of age)
- Renal function at 6 months of life(6 months of life)
- Survival rate at 6 months(Up to 6 months of life)
- Renal function at 1 year of age(1 year of age)
研究者
Rodrigo Ruano
PhD
University of Sao Paulo General Hospital