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Fetal Bladder size


- candidate number23395
- NTR NumberNTR5483
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2015
- Secondary IDsNL54636.042.15. METC
- Public TitleFetal Bladder size
- Scientific TitleSize and volume charts of fetal bladder during the second and third trimester of pregnancy
- ACRONYMFEBLA
- hypothesis
- Healt Condition(s) or Problem(s) studiedUreteral damage, Urinary retention
- Inclusion criteriaPhysiological singleton pregnancy in healthy women aged 18 or older, carrying a fetus without structural anomalies and capable of reading the Dutch language will be recruited at the dating scan (10-14 weeks).
Moreover twenty cases referred to our Fetal Unit for fetal mild pyelectasy, defined as an anteroposterior diameter of renal pelvis between 5-10 mm, will be included in the study.
- Exclusion criteriaIncapacitated adults, maternal disease that are likely to affect the fetal growth (hypertension requiring therapy, diabetes mellitus), multiple pregnancies, the presence of fetal malformation, abnormal karyotype or any other disease at birth.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- control[default]
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 15-jan-2015
- planned closingdate16-mei-2015
- Target number of participants300
- InterventionsNone
- Primary outcomeConstruction of reference curves for fetal bladder diameters and volume in the second and third trimester of pregnancy. .
- Secondary outcomeThe variation in the dimensions of renal pelvis in relation to the degree of bladder filling in healthy fetuses compared to 20 cases with mild pielectasy (defined as an antero-posterior renal pelvis between 5 and 10 mm) will be investigated. Moreover, we will prospectively validate both the cut-off of bladder enlargement derived from this study in 20 cases of megacystis diagnosed in subsequent years
- Timepoints- Recruitment process: December 2015/January 2016
- Data collection: February - May 2016
- Data Analysis: May - August 2016
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Federica Fontanella
- CONTACT for SCIENTIFIC QUERIES C. M. Bilardo
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD16-nov-2015 - 5-jan-2016


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