Recruiting

Prenatal CareStandardized Prenatal Clinical Care for LUTO

Sponsor:

Baylor College of Medicine

Code:

NCT02315521

Conditions

Urethral Obstruction

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Fetal Intervention for LUTO

Study Details

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.

Conditions

Urethral Obstruction

Study ID

NCT02315521

Start date

Dec, 2014

Status verified date

Nov, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Fetuses with LUTO before 18 weeks

Group 2

Fetuses with LUTO between 18 and 30 weeks

Group 3

Fetuses with LUTO between 30 and 34 weeks

Group 4

Fetuses with LUTO after 34 weeks

Interventions

Fetal Intervention for LUTO

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michael A Belfort, MD PHD

832-826-7375 belfort@bcm.edu

Rebecca M Johnson, BA

832-826-7451 rj2@bcm.edu

Locations

Texas Children's Hospital - Pavilion for Women

Recruiting

Houston, Texas, United States, 77030

Contacts

Michael Belfort, MD PhD

832-826-7375 belfort@bcm.edu

Rebecca J Johnson, BA

832-826-7451 rj2@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

lower urinary tract obstruction
posterior urethral valves
urethral atresia
Prune Belly Syndrome
Megalo-urethra
Fetal renal function
Prenatal Diagnosis
Ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2025-11-14.