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

A randomised controlled trial comparing intra- uterine vesico- amniotic shunting vs. not shunting in the treatment of congenital bladder outflow obstruction. - PLUTO trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33244

Enrollment

Registered

2009-07-09

Start date

2009-11-23

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Lower Urinary Tract Obstruction

Interventions

Vesico- amniotic shunting.

Eligibility

Inclusion criteria

Inclusion criteria: Mother: - Written informed consent. - Able to understand information provided (use of interpreter may be required) - Singleton pregnancy Fetus: - Male fetus - Evidence of isolated bladder outflow obstruction from ultrasound imaging in the first and second trimester (up to 28 weeks) -(Optional: Vesicocentesisi)

Exclusion criteria

Exclusion criteria: - Additional major structural or chromosomal anomaly - Relatively advanced gestation (> 28 weeks)

Design outcomes

Primary

Measure	Time frame
Perinatal mortality and renal function.	—

Secondary

Measure	Time frame
Degree of reflux, long term effect.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)