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Standardized Prenatal Clinical Care for LUTO

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ClinicalTrials.gov Identifier: NCT02315521
Recruitment Status : Recruiting
First Posted : December 12, 2014
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Belfort, Baylor College of Medicine

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.

Condition or disease Intervention/treatment
Urethral Obstruction Procedure: Fetal Intervention for LUTO

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Validation of the Standardized Prenatal Clinical Management of Fetuses With Lower Urinary Tract Obstruction (LUTO)
Study Start Date : December 2014
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
Fetuses with LUTO before 18 weeks
Procedure: 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.

Other Names:
  • Fetal vesico-amniotic shunting
  • Fetal cystoscopy

Group 2
Fetuses with LUTO between 18 and 30 weeks
Procedure: 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.

Other Names:
  • Fetal vesico-amniotic shunting
  • Fetal cystoscopy

Group 3
Fetuses with LUTO between 30 and 34 weeks
Procedure: 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.

Other Names:
  • Fetal vesico-amniotic shunting
  • Fetal cystoscopy

Group 4
Fetuses with LUTO after 34 weeks



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   11 Weeks to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All pregnant women referred to our Fetal Center with confirmed diagnosis of fetal LUTO. The diagnosis of fetal LUTO is based on the presence of enlarged bladder and bilateral hydronephrosis.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315521


Contacts
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Contact: Michael A Belfort, MD PHD 832-826-7375 belfort@bcm.edu
Contact: Rebecca M Johnson, BA 832-826-7451 rj2@bcm.edu

Locations
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United States, Texas
Texas Children's Hospital - Pavilion for Women Recruiting
Houston, Texas, United States, 77030
Contact: Michael Belfort, MD PhD    832-826-7375    belfort@bcm.edu   
Contact: Rebecca J Johnson, BA    832-826-7451    rj2@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Michael Belfort, MD PHD Baylor College of Medicine

Additional Information:

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Responsible Party: Michael Belfort, Professor and Chairman, Department of Obstetrics and Gynecology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02315521     History of Changes
Other Study ID Numbers: BCM H-35770
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Belfort, Baylor College of Medicine:
lower urinary tract obstruction
posterior urethral valves
urethral atresia
Prune Belly Syndrome
Megalo-urethra
Fetal renal function
Prenatal Diagnosis
Ultrasound

Additional relevant MeSH terms:
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Urethral Obstruction
Urethral Diseases
Urologic Diseases