Size and volume charts of fetal bladder during the second and third trimester of pregnancy

Completed

Conditions: Lower urinary tract obstructions
Enlarged Fetal Bladder
10038360
10028920
10004994

Registration Number: NL-OMON42511

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

Physiological 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 mild pyelectasy, defined as an anteroposterior diameter of renal pelvis between 5-10 mm during pregnancy, will be included in the study.

Exclusion Criteria

Exclusion criteria are: incapacitated adults, maternal disease that are likely to affect the fetal growth (hypertension requiring therapy, diabetes mellitus), multiple pregnancies, the presence of fetal anomalies, abnormal karyotype or any other disease at birth. Congenital abnormalities will be ruled out at the second trimester abnormality scan and / or after birth

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoint will concern the creation of reference charts for fetal bladder<br /><br>dimension and volume in the second and third trimester of pregnancy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint will be the prospective validation of both reference charts<br /><br>and prediction model designed by MEBLA study (NL54637.042.15) in 20 cases of<br /><br>megacystis diagnosed in subsequent years</p><br>