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Not yet recruitingNCT06896149FHYDOUpdated Mar 26, 2025

Mild Fetal Hydronephrosis, Gestational Diabetes and Spontaneous Resolution vs Moderate-severe Fetal Hydronephrosis, Obstructive Causes and Worse Postnatal Outcome

An observational study in Hydronephrosis and Gestational Diabetes, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged Up to 55 Years. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
800
Ages
Up to 55 Years
Sex
All
01

Study summary

Renal pelvis dilatation can be a relatively common finding on obstetric antenatal ultrasounds occurring in 1% to 5% of all pregnancies, with a known predilection for the male sex. Fetal hydronephrosis can be ascribed to structural obstructive conditions or functional origin causes. The latter are characterized by the transience of the clinical picture, which appears milder in degree, onset at later gestational ages, a course of substantial stability and spontaneous regression, sometimes as early as during pregnancy or early postnatal life. Fetal hydronephrosis related to structural obstructive causes, on the other hand, classically presents an earlier onset, a worsening course during pregnancy and often requires postnatal surgical correction. Additional ultrasound findings that contribute to prognosis include those indicative of an associated congenital anomaly of the kidneys and urinary tract (CAKUT). The risk of postnatal pathology in mild prenatal hydronephrosis is reported to be between 11% and 15%. It increases up to 27-45% in fetuses with moderate prenatal hydronephrosis and up to 53- 88% in cases of severe hydronephrosis. In the outpatient clinical practice of prenatal ultrasonography, is hypothesized an association between mild, mono- bilateral fetal hydronephrosis as an isolated ultrasound finding and gestational diabetes. In this population, this study aims to highlight the stability of the sonographic picture, relative improvement with effective glycemic control with diet or medical therapy, and subsequent spontaneous resolution in early postnatal life. A possible causal link between the two conditions could lie in the association of poorly controlled gestational diabetes with fetal hyperglycemia, which would cause increased osmotic diuresis resulting in polyuria and subsequent hydronephrosis. In contrast, is hypothesized an association between earlier-onset moderate-to-severe fetal hydronephrosis, its worsening progression throughout pregnancy and the anatomic abnormalities finding in the fetal urinary tract, in no correlation with maternal gestational diabetes. This condition correlates with increased postnatal complications (e.g., recurrent urinary infections, need for antibiotic prophylaxis, etc.) and a more severe postnatal outcome that may require surgical correction. To date, there is limited scientific literature concerning the functional causes of fetal hydronephrosis, as opposed to obstructive causes, which have been more analyzed and classified. This ambispective observational case-control study aims to evaluate pregnant women accessing the obstetric ultrasound and obstetric day hospital outpatient clinics of the Fondazione Policlinico A. Gemelli- IRCCS with ultrasound finding of mono-bilateral fetal hydronephrosis during the second and third trimester of pregnancy. In this population we will define the fetal hydronephrosis degree, its evolution, the association with maternal metabolic disorders, in order to estimate postnatal morbidity. All prenatal ultrasound images will be interpreted by the same group of specialists. To assess the degree of fetal hydronephrosis, the classification system developed by SFU in 1993 will be used. The latter is the most commonly used among pediatric urologists for grading neonatal and infant pelvic disorders:

  • grade 0: no dilatation, calico walls paired with each other
  • grade 1 (mild): dilation of the renal pelvis without dilation of the calyces
  • grade 2 (mild): dilatation of the renal pelvis (mild) and calyces
  • grade 3 (moderate): moderate dilatation of the renal pelvis and calyces; dulling of the fornixes and flattening of the papillae; possible mild cortical thinning
  • grade 4 (severe): gross dilatation of renal pelvis and calyces; cortical thinning.

The diagnosis of gestational diabetes will be defined by an altered oral glucose tolerance test (OGTT) result or elevated glycosylated hemoglobin (HBA1c) values. In addition, the presence of a flat OGTT trend suggestive of an insulin resistance condition will also be considered pathological. The OGTT will be performed between weeks 24 and 28 of pregnancy, as per the guidelines. In patients at high risk of developing gestational diabetes, early screening will be performed between sixteen and eighteen weeks of pregnancy. Amniotic fluid will be assessed according to one of the following ultrasound criteria:

  • calculation of amniotic fluid index (AFI) by summing the vertical depth of amniotic fluid measured in each quadrant of the uterus
  • With the single deepest pocket (SDP). Polydramnios is diagnosed when the amniotic fluid index (AFI) is ≥ 250 mm, the single deepest pocket (SDP) is ≥ 80 mm, or when the examiner subjectively assesses an increase in amniotic fluid. Oligohydramnios is diagnosed when the AFI is ≤ 50 mm or when the SDP is ≤ 20 mm.
02

Conditions studied

  • Hydronephrosis
  • Gestational Diabetes
03

In context

Hydronephrosis

55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.

This study's planned enrollment of 800 is above the median of 78 across 25 observational studies indexed under Hydronephrosis.

Browse Hydronephrosis studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pregnant women accessing the Obstetric ultrasound clinics and the obstetrics DH of Fondazione Policlinico A. Gemelli- IRCCS with or without a diagnosis of gestational diabetes, with ultrasound finding of fetal hydronephrosis of different grades and assessment of the evolution of hydronephrosis in the newborn in the first six months of postnatal life.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written .
  • Single pregnancy in normal progression, in presence of single or bilateral fetal hydronephrosis of any grade of severity with or without a gestational diabetes diagnosis and without evidence of other ultrasound detectable abnormalities of the fetus affecting other anatomical districts (cases).
  • Single physiological pregnancy in normal evolution without finding of fetal hydronephrosis and gestational diabetes (controls).
  • Single pregnancy with a diagnosis of gestational diabetes in the absence of fetal hydronephrosis (controls).
  • Having performed at least one prenatal ultrasound at the obstetric ultrasound clinics and obstetric DH of the Foundation.
  • Have been screened for gestational diabetes.

Exclusion criteria

Exclusion Criteria

  • Detection of other major malformations and genetic syndromes in the fetus.
  • Twin pregnancies.
  • Maternal conditions such as diabetes insipidus, type I and type II diabetes mellitus.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fetal hydronephrosis (cases)

    * Single pregnancy in normal progression, in presence of single or bilateral fetal hydronephrosis of any grade of severity from G1 to G4 with a gestational diabetes diagnosis (cases). * Single pregnancy in normal progression, in presence of single or bilateral fetal hydronephrosis of any grade of severity from G1 to G4 without a gestational diabetes diagnosis (cases).

    Diagnostic Test: Obstetric ultrasound

  • No fetal hydronephrosis (controls)

    * Single physiological pregnancy in normal evolution without finding of fetal hydronephrosis and gestational diabetes. * Single pregnancy with a diagnosis of gestational diabetes in the absence of fetal hydronephrosis.

    Diagnostic Test: Obstetric ultrasound

Interventions

  • Diagnostic testObstetric ultrasound

    Ultrasound focus on fetal renal pelvis, amniotic fluid assessment, and fetal weight estimation.

    Also known as: Data collection of oral glucose tolerance test, fasting blood glucose, or glycated hemoglobin., Collection of postnatal kidney and urinary tract ultrasound examination data, performed according to clinical protocols, up to 6 months of postnatal life.

06

What researchers measure

Primary outcomes

  1. Mild fetal Hydronephrosis in patients with gestational diabetes

    This study aims to evaluate if gestational diabetes can be associated with mild grade (G1-G2) fetal hydronephrosis based on all clinical data present at the time of admission and obstetric ultrasound data.

    Time frame: 1 year

Secondary outcomes

  1. Fetal hydronephrosis grade in women with and without gestational diabetes

    to compare fetal hydronephrosis in pregnant women with and without gestational diabetes

    Time frame: 3 years

  2. Moderate to severe fetal hydronephrosis and gestational diabetes

    To demonstrate the absence of association between moderate-to-severe fetal hydronephrosis (G3-G4) and gestational diabetes, collecting all clinical data present at the time of admission and obstetric ultrasound data.

    Time frame: 3 years

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06896149
Responsible party
Sponsor
First posted
Mar 26, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
May 31, 2026 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Mar 26, 2025

Study contacts

Anita Romiti
Contact
anita.romiti@policlinicogemelli.it
+390630155701
Anita Romiti, MD
principal investigator · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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