NephropathyFUS-IRCNCT06806644
The Role of Ultrasonography in Predicting Outcomes of Fetal Nephropathy
An observational study of Nephropathy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Nephropathy
- How many people
- 190 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jan 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Request for voluntary termination of pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
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.
Read more
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.
Read the detailed description
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:
- Age
- Type of suspected nephropathy (pyelectasis, hydronephrosis/hydroureteronephrosis, multicystic kidney, dysplasia)
- Gestational age at the time of suspected diagnosis
- Gestational age at the time of diagnosis
- Assessment of amniotic fluid
- Centile of affected kidney (<5°, normal, >95°)
- Centile of unaffected kidney (<5°, normal, >95°)
- Presence of associated abnormalities in the other anatomical districts
- Performance of invasive prenatal diagnostic methods (Karyotype analysis and CGH-array)
- Progression of nephropathy
- Involvement of contralateral kidney
- Gestational age at the time of delivery
- Mode of delivery (vaginal/caesarean section)
- Sex of the newborn at birth
- Infant's weight at birth
- Ph of newborn at birth
- APGAR index at 5 and 10 minutes
- Possible admission to neonatal intensive care unit.
- Conditions
- Nephropathy
- Keywords
- Fetal nephropathy
- Medical subject headings
- Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start3 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephropathyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluigi Pilu, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806644
- Sponsor's protocol ID
- FUS-IRC
- Acronym
- FUS-IRC
- Status last verified
- Oct 2024
- First submitted
- 30 Dec 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ultrasonography in Predicting Outcomes of Fetal Nephropathy
- ClinicalTrials.gov ID
- NCT06806644
- Acronym / sponsor ID
- FUS-IRC / FUS-IRC
- Conditions
- Nephropathy
- Keywords
- Fetal nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Age
- Type of suspected nephropathy (pyelectasis, hydronephrosis/hydroureteronephrosis, multicystic kidney, dysplasia)
- Gestational age at the time of suspected diagnosis
- Gestational age at the time of diagnosis
- Assessment of amniotic fluid
- Centile of affected kidney (<5°, normal, >95°)
- Centile of unaffected kidney (<5°, normal, >95°)
- Presence of associated abnormalities in the other anatomical districts
- Performance of invasive prenatal diagnostic methods (Karyotype analysis and CGH-array)
- Progression of nephropathy
- Involvement of contralateral kidney
- Gestational age at the time of delivery
- Mode of delivery (vaginal/caesarean section)
- Sex of the newborn at birth
- Infant's weight at birth
- Ph of newborn at birth
- APGAR index at 5 and 10 minutes
- Possible admission to neonatal intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Request for voluntary termination of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianluigi Pilu, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephropathy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: After delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.