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Prenatal treatment of Lower Urinary Tract Obstruction

A multi-centre randomised controlled trial comparing intra-uterine vesico-amniotic shunting versus not shunting in the treatment of congenital bladder outflow obstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53328556
Enrollment
200
Registered
2005-09-21
Start date
2005-09-01
Completion date
Unknown
Last updated
2017-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital bladder outflow obstruction Neonatal Diseases Congenital obstructive defects of renal pelvis and congenital malformations of ureter

Interventions

Fetal vesico-amniotic shunt versus no shunt.

Sponsors

University of Birmingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Mother: 1. Written informed consent given 2. Able to understand information provided (use of interpreter may be required) 3. Singleton pregnancy Foetus: 1. Evidence of bladder outflow obstruction from ultrasound imaging 2. No major extra genitourinary anomalies present

Exclusion criteria

Exclusion criteria: Additional major structural or chromosomal anomaly

Design outcomes

Primary

MeasureTime frame
Perinatal mortality rates and renal function at 4 - 6 weeks and 12 months measured via: 1. Serum creatinine 2. Renal ultrasound 3. Need for dialysis/transplant

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026