Vesicoamniotic shunting with a Somatex® intrauterine shunt for fetal megacystis in the first trimester

Vesicoamniotic shunting with a Somatex® intrauterine shunt for fetal megacystis in the first trimester - IUS1st

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017779

Enrollment

Registered

2023-01-31

Start date

2019-06-24

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

N13

Interventions

Group 1: Fetuses with megacystis diagnosed in the 1st trimenon that were treated with vesicoamniotic Somatex-Shunt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Singelton pregnancy with fetal megacystis • Megacystis >15mm

Exclusion criteria

Exclusion criteria: - Absence of capacity of pregnant woman to give consent - Lack of capacity to give consent - Lack of indication for sonographic examination. - Presence of general contraindications against the use of sonographic examinations and intrauterine punctures. - Other fetal sonographic abnormalities at the time of indication. - Proven fetal chromosomal abnormality - 14+0 weeks of gestation or older at diagnosis

Design outcomes

Primary

Measure	Time frame
perinatal mortality (7 days postnatal survival)	—

Secondary

Measure	Time frame
Nephrological outcome until school age (serum creatinine, need for dialysis/transplant, renal ultrasound), Cause of megacystis, Bladder function until school age, pediatric outcome until school age. Shunt-associated complications.	—

Countries

Germany

Contacts

Public ContactEva Weber

Universitätsklinikum Bonn

eva.weber@ukbonn.de+49 228 28737115

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026