Status:
NOT_YET_RECRUITING
Mild Fetal Hydronephrosis, Gestational Diabetes and Spontaneous Resolution vs Moderate-severe Fetal Hydronephrosis, Obstructive Causes and Worse Postnatal Outcome
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Hydronephrosis
Gestational Diabetes
Eligibility:
All Genders
Up to 55 years
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06896149
Start Date
April 1 2025
End Date
February 28 2028
Last Update
March 26 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e patologia ostetrica
Roma, Italia, Italy, 00168