Standardized Prenatal Clinical Care for LUTO

Conditions

• Urethral Obstruction

Eligibility Criteria

Sex

ALL

Age

11 Weeks - 2 Years

Healthy Volunteers

Not accepted

Interventions

• Fetal Intervention for LUTO — PROCEDURE
  Fetal vesico-amniotic shunting placement consists in placing a shunt (stent) percutaneously from fetal bladder to the amniotic cavity under ultrasound guidance. Fetal cystoscopy will be performed using a thin scope that will be introduced to the fetal bladder for evaluation of the cause of the obstruction and ablation of the posterior urethral valves.

Study Details

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.

Key Dates

Start date

Dec 31, 2014

Status verified

Nov 2025

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Group 1
  Fetuses with LUTO before 18 weeks
• Arm: Group 2
  Fetuses with LUTO between 18 and 30 weeks
• Arm: Group 3
  Fetuses with LUTO between 30 and 34 weeks
• Arm: Group 4
  Fetuses with LUTO after 34 weeks

Primary Outcome Measure

Survival rate [ Time Frame: Survival rate since prenatal period to 24 months of life ]

Central Contacts

• Michael A Belfort, MD PHD
  832-826-7375
  [email protected]
• Rebecca M Johnson, BA
  832-826-7451
  [email protected]

Locations (1)

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