Standardized prenatal care for fetuses with urethral obstruction
Validation of the Standardized Prenatal Clinical Management of Fetuses With Lower Urinary Tract Obstruction (LUTO)
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 11 Weeks to 2 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02315521 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women whose fetuses have been diagnosed with LUTO, regardless of gestational age.
Not a fit: Patients with abnormal chromosomal/genetic diseases or other structural anomalies not related to LUTO may not benefit from this study.
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 performed: While this approach is based on existing literature, the standardized management protocol for LUTO is a novel application in a clinical setting.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.