Standardized prenatal care for fetuses with urethral obstruction
Official title: Validation of the Standardized Prenatal Clinical Management of Fetuses With Lower Urinary Tract Obstruction (LUTO)
Run by Baylor College of Medicine · NCT02315521 · Data updated 2026-11-12
This study is trying out a new standard care plan for pregnant women whose babies have been diagnosed with a urinary blockage to see if it helps improve outcomes for both mom and baby.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 11 Weeks to 2 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | December 2014 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT02315521 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women whose fetuses have been diagnosed with LUTO, regardless of gestational age.
✕Probably not a fit
Patients with abnormal chromosomal/genetic diseases or other structural anomalies not related to LUTO may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to implement a standardized prenatal management protocol for fetuses diagnosed with lower urinary tract obstruction (LUTO). Pregnant women carrying affected fetuses will undergo a comprehensive evaluation at a specialized Fetal Center, including ultrasounds, genetic counseling, and consultations with a multidisciplinary team. The study will also involve the collection of maternal and fetal samples for analysis and future research. The goal is to validate this management approach based on existing scientific evidence.
Why it matters
Potential benefit: If successful, this study could improve prenatal care and outcomes for fetuses with lower urinary tract obstruction.
How similar studies have gone: While this approach is based on existing literature, the standardized management protocol for LUTO is a novel application in a clinical setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Texas Children's Hospital - Pavilion for Women
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Michael Belfort, MD PHD — Baylor College of Medicine
- Study coordinator: Michael A Belfort, MD PHD
- Email: belfort@bcm.edu
- Phone: 832-826-7375
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.