Clinical Trial: Standardized Prenatal Clinical Care for LUTO

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

Brief Summary: 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.

Detailed Summary:

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.

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
Sponsor: Baylor College of Medicine

Current Primary Outcome: Survival rate [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Postnatal renal function at 6 months of life [ Time Frame: During neonatal period and at 6 months of life ]
    Renal function during neonatal period and at 6 months of life will be evaluated by analyzing the serum creatinine, weight and height, renal function, bladder function, lung disease, need for dialysis and transplantation, arterial hypertension, incontinence and developmental delay
  • Postnatal renal function at 12 months of life [ Time Frame: During neonatal period and at 12 months of life ]
    Renal function during neonatal period and at 12 months of life will be evaluated by analyzing the serum creatinine, weight and height, renal function, bladder function, lung disease, need for dialysis and transplantation, arterial hypertension, incontinence and developmental delay
  • Postnatal renal function at 24 months of life [ Time Frame: During neonatal period and at 24 months of life ]
    Renal function during neonatal period and at 24 months of life will be evaluated by analyzing the serum creatinine, weight and height, renal function, bladder function, lung disease, need for dialysis and transplantation, arterial hypertension, incontinence and developmental delay


Original Secondary Outcome: Postnatal renal function [ Time Frame: During neonatal period and at 6, 12 and 24 months of life ]

Renal function during neonatal period and at 6, 12 and 24 months of life will be evaluated by analyzing the serum creatinine, weight and height, renal function, bladder function, lung disease, need for dialysis and transplantation, arterial hypertension, incontinence and developmental delay


Information By: Baylor College of Medicine

Dates:
Date Received: December 9, 2014
Date Started: December 2014
Date Completion: November 2019
Last Updated: November 28, 2016
Last Verified: November 2016