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Coral

Prospective study to Correlate fetal Renal ArteryDopplerwith postnatal outcome - Prospective study to Correlate fetal Renal ArteryDopplerwith postnatal outcome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58407
Enrollment
160
Registered
2025-08-18
Start date
2026-05-04
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

congenital anomaly of the kidneys and/ or urinary tract congenital anomaly of the kidneys and/ or urinary tract

Interventions

Doppler ultrasound (with the Voluson ultrasound machine)&nbsp

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: Case group (CAKUT-group): Singleton pregnancies of women at least 18 years old with confirmed CAKUT and capable of reading and understanding the Dutch language, referred to the UMCG at ±20 weeks of GA or ±30 weeks of GA for a GUO-2. Control group (healthy pregnancies): Physiological singleton pregnancy in healthy women of at least 18 years, carrying a fetus without chromosomal or structural abnormalities and without maternal influences that affect fetal growth/ doppler (pre-existing hypertension, diabetes mellitus, renal disease, smokers) or pregnancy complications (pre-eclampsia, FGR, diabetes) and capable of reading and understanding the Dutch language will be recruited for our study.

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: Case group (CAKUT-group): Multiple pregnancy and fetuses with CAKUT who have associated anomalies that affect specific hemodynamics will be excluded (e.g., congenital heart defects). Control group (Healthy pregnancies): Multiple pregnancy, fetuses with congenital/ structural/ chromosomal anomaly, fetal growth restriction (FGR), intra-uterine fetal demise/ stillbirth, maternal influences that affect fetal growth/doppler measurement: preexisting hypertension, Diabetes Mellitus (DM), renal disease, pregnancy complications: pre-eclampsia, diabetes.

Design outcomes

Primary

MeasureTime frame
1). To determine whether there is a difference in the pulsatility index (PI) and resistance index (RI) of the fetal renal artery between fetuses with CAKUT and those from healthy pregnancies during an advanced anomaly scan (geavanceerd ultrageluidsonderzoek, GUO), measured in the most recent available ultrasound scan measurement.

Secondary

MeasureTime frame
1). To investigate the prognostic value of fetal RAD on renal outcome* in fetuses with CAKUT during an advanced ultrasound scan by measuring the flow parameters of the fetal renal artery and comparing these flow parameters with healthy pregnancies. 2). To investigate whether machine learning and radiomics analysis of prenatal renal ultrasound images can enhance the prediction of postnatal renal outcomes, either independently or in combination with Doppler parameters. 3). To assess whether altered fetal renal perfusion (as detected by Doppler) is associated with changes in systemic fetal hemodynamics, particularly involving the heart (e.g., myocardial strain) and the brain (e.g., middle cerebral artery Doppler), suggesting compensatory circulatory adaptations. 4. To assess changes in renal artery Doppler flow patterns in fetuses between the different ultrasounds at different gestational ages, and to explore whether early measurements predict later flow patterns. *Renal outcome will be based on different outcomes, such as the imaging results, biochemical tests in blood and urine and vital/ physical parameters.

Countries

Netherlands

Contacts

Public ContactL.A.M. Brinkman

Universitair Medisch Centrum Groningen

l.a.m.brinkman@umcg.nl0503616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026