Standardized Prenatal Clinical Care for LUTO
ConditionUrethral Obstruction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-2
SponsorBaylor College of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Presence of abnormal chromosomal/genetic disease
Presence of other associated structural anomaly that is not part of LUTO.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fetal Intervention for LUTO
Procedure/SurgeryFetal 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.
Treatment groups
50 Participants
are divided into 4 treatment groupsGroup A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention
Group D: Group 40 interventions
Trial outcomes
Primary outcomes
1
Survival rate
The survival rate from the prenatal period up to 24 months of life will be evaluated
Time frame
Survival rate since prenatal period to 24 months of lifeSecondary outcomes
1
Postnatal renal function 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
Time frame
During neonatal period and at 6 months of life2
Postnatal renal function 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
Time frame
During neonatal period and at 12 months of life3
Postnatal renal function 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
Time frame
During neonatal period and at 24 months of lifeSponsors and contacts
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Source ClinicalTrials.gov