IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
NCT Number: NCT06806644
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.
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Notify Me18 year–45 year
Female
Observational
Bologna, 40138, Italy
Clinical data of single-pregnancy patients who were referred to the Pregnancy at Risk Outpatient Clinics of our center between 2007 and 2023 will be considered.
These patients were evaluated with serial ultrasound checks at the outpatient clinics for the presence of suspected unilateral nephropathy that emerged during morphologic ultrasound performed between the 19th and 21st weeks of gestation. Therefore, we will analyze the ultrasound data that emerged during serious outpatient checkups, the delivery data of patients who delivered at our center, and the postnatal data of newborns.
Information on the following will be collected for each patient:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: After delivery
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.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Acronym: FUS-IRC
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