The Role of Ultrasonography in Predicting Outcomes of Fetal Nephropathy

NCT06806644 | Completed

• 1 other identifier: FUS-IRC
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital anomalies of the kidneys and urinary tract are among the most frequently ultrasound-indentified malformations in the prenatal period. Thanks to the introduction of fetal ultrasound in pregnancy screening programs, the diagnosis of these abnormalities in utero allows early manegement. In fact, prenatal diagnosis allows evolutionary control of the pathology and appropriate counseling, putting in place the best therapeutic strategies at birth. However, the predictive value of prenatal ultrasound findings is often difficult to establish. Therefore, the investigators want to evaluate the postnatal outcomes in fetuses prenatally diagnosed with unilateral nephropathy, specifically the rate of live births, gestational age at delivery, neonatal weight, and the need for admission of the infant to the neonatal intensive care unit (NICU). The data collected will allow investigators to assess postnatal outcomes in fetuses prenatally diagnosed with unilateral nephropathy, identifying the prenatal ultrasound findings most associated with poor postnatal prognosis to define the role of ultrasonography in predicting outcomes of fetal nephropathy.

Conditions

Nephropathy

Keywords

Fetal nephropathy

Outcome Measures

Primary Outcomes (1)

• Measurement of rate of live births, gestational age at delivery, neonatal weight, and need for admission of the newborn to the neonatal intensive care unit (NICU).

  For quantitative continuous type variables, the intraclass correlation coefficient (ICC) will be used, and for dichotomous variables, Cohen's k test will be used. For the variables considered in the study, parametric or nonparametric tests will be used according to their distribution. Quantitative variables will be analyzed with Student's t-test and/or Mann-Whitney test for comparison between the two groups. Qualitative variables, on the other hand, will be analyzed by comparison of proportions and KaplanMeier algorithm with related Log Rank test. Cox regression will be used to assess the possible effect of covariates and confounding factors on the primary outcome.

  After delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients evaluated with serial ultrasound checks at the outpatient clinics of this center for the presence of risk factors for unilateral fetal nephropathy will be considered.

You may qualify if:

• Single pregnancy
• Age greater than or equal to 18 years
• Detection of Unilateral Renal Abnormalities during Confidential Ultrasound
• Delivery performed at the O.U. of Obstetrics and Prenatal Age Medicine
• Acquisition of informed consent form

You may not qualify if:

• Request for voluntary termination of pregnancy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Gianluigi Pilu, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 4, 2025
• Study Start: January 3, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 4, 2025

Record last verified: 2024-10

Locations

IT (1)