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Search / Trial NCT06896149

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 19, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the relationship between fetal hydronephrosis, which is a condition where the kidney's drainage system becomes swollen due to urine buildup, and gestational diabetes, a type of diabetes that can develop during pregnancy. The researchers want to understand how mild cases of fetal hydronephrosis might resolve on their own, especially in pregnant women with gestational diabetes who can manage their blood sugar levels effectively. They will also look at more severe cases of hydronephrosis that may lead to complications after birth and whether there is any connection to maternal gestational diabetes.

To participate in the trial, pregnant women must be having a single pregnancy that is progressing normally and have either mild or severe fetal hydronephrosis, with or without a diagnosis of gestational diabetes. Participants will undergo prenatal ultrasounds and assessments to monitor the condition of the fetal kidneys and any related health issues. The study aims to gather more information on how these conditions interact and could help improve care for both mothers and babies in the future. If you are interested in joining, it’s essential that you discuss this with your healthcare provider to ensure you meet the eligibility criteria.

Gender

ALL

Eligibility criteria

  • Inclusion criteria
  • Written informed consent.
  • 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
  • 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, Lazio, Italy

Patients applied

0 patients applied

Trial Officials

Anita Romiti, MD

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported