跳至主要内容
临床试验/NCT02315521
NCT02315521招募中不适用

Validation of the Standardized Prenatal Clinical Management of Fetuses With Lower Urinary Tract Obstruction (LUTO)

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Survival rate

研究概览

简要总结

The investigators propose a standardized prenatal management, based on the scientific evidence published in the literature, to manage prenatally fetuses with lower urinary tract obstruction (LUTO). The present study is a prospective registry that will evaluate and validate this standardized prenatal management for LUTO.

详细描述

Patients with LUTO will come for clinical evaluation as part of the standard clinical care at the our Fetal Center. The standardized prenatal management of plan for fetuses with LUTO is described in details bellow.

All pregnant women carrying fetuses with LUTO are assigned to the nurse coordinator and the prenatal records are obtained. The multidisciplinary team (maternal-fetal intervention team, pediatric urologists, pediatric nephrologist, neonatologist, genetic counselors and fetal cardiologists) will be notified. A one-day visit is planned with the following: 1. a fetal comprehensive ultrasound is scheduled for the confirmation of the diagnosis, investigation of associated anomalies and evaluation of prognostic factors; 2. a genetic counseling is performed and fetal invasive tests (FISH/fetal karyotype/fetal CMA) are offered to the patients; 3. Fetal echocardiogram is also performed to evaluate the presence of associated cardiac anomalies and the fetal cardiac function; 4. A consultation with the Fetal Intervention team (maternal-fetal specialty) is scheduled as well. Additionally, maternal and fetal samples (maternal blood, amniotic fluid, fetal blood, and fetal urine) will be collected as part of the standardized clinical management. We plan to investigate the analysis of those samples, and to also collect more samples for banking to be used in future studies.

If the gestational age is less than 18 weeks and isolated LUTO is confirmed on ultrasonography, patient is giving the option for prenatal expectant management, or fetal intervention or termination of pregnancy. If patient elects to proceed with fetal intervention, vesico-amniotic shunting is performed and patient is followed by ultrasound once a week. In case the shunt migrates or seems to be obstructed, we will offer repeating the procedure to the patient. If patient elects to proceed with expectant management, follow-up will be every 4 weeks. Delivery date and type of delivery depend on the obstetrical indications.

For fetuses at gestational age greater than 18 and less than 30 weeks, if oligohydramnios is present, investigation of fetal renal biochemistry is offered. In case of favorable fetal renal biochemistry, vesico-amniotic shunt is offered as a fetal therapeutic intervention. In case the fetal urinary biochemistry is considered not favorable, then we will repeat the urinary examination in 24 hours. If the fetal urinary biochemistry is still not favorable, we will repeat the examination for the last time (maximum of 3 times). If it is still not favorable, then fetal vesico-amniotic shunt is not offered. However, if a fetal urinary examination reveals improvement favorable urinary biochemistry), fetal vesico-amniotic shunting is considered. Prenatal follow-up and delivery follow the same algorithm described previously.

If gestational age is greater than 30 weeks and less than 34 weeks and isolated LUTO is diagnosed, fetal intervention is offered if oligohydramnios is present. If no oligohydramnios is identified, no fetal intervention is offered and patient is followed until delivery. Delivery date and type of delivery depend on the obstetrical indications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
11 Weeks 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • - Pregnant women whose fetuses have diagnosis of LUTO independently from the gestational age at diagnosis.

排除标准

  • Presence of abnormal chromosomal/genetic disease
  • Presence of other associated structural anomaly that is not part of LUTO.

结局指标

主要结局

Survival rate

时间窗: Survival rate since prenatal period to 24 months of life

The survival rate from the prenatal period up to 24 months of life will be evaluated

次要结局

  • Postnatal renal function at 24 months of life(During neonatal period and at 24 months of life)
  • Postnatal renal function at 12 months of life(During neonatal period and at 12 months of life)
  • Postnatal renal function at 6 months of life(During neonatal period and at 6 months of life)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael A Belfort

Professor and Chairman, Department of Obstetrics and Gynecology

Baylor College of Medicine

研究点 (1)

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