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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03407807
Other study ID # RECHMPL17_0331
Secondary ID
Status Completed
Phase N/A
First received October 25, 2017
Last updated January 15, 2018
Start date January 2017
Est. completion date September 2017

Study information

Verified date October 2017
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst


Description:

The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst. The investigators performed a retrospective study in the Montpellier Prenatal Diagnosis Centre between 2007 and 2017. All pregnant women referred to this unit after routine ultrasound examination with a suspected splenic cyst were included. Participant all benefit a reference ultrasound to perform a detailed morphological examination. In any doubt about diagnosis, a MRI exam wad proposed. Then patient were followed regularly. At birth, all newborn babys had medical examination to search early complication. Then, children had a surgical consultation and regular ultrasound examinations were performed.


Recruitment information / eligibility

Status Completed
Enrollment 5450
Est. completion date September 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pregnent women with an isolated suspected fetal splenic cyst between 2007 and 2017 in Montpellier Prenatal Diagnosis Center

Exclusion Criteria:

- All others fetal diagnosis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prenatal ultrasound evolution of fetal splenic cysts during pregnancy Prenatal ultrasound evolution of fetal splenic cysts during pregnancy: persistence, increasing/decreasing in size, disappearance 1 day
Secondary Prenatal Magnetic Resonance imaging (MRI) evolution of fetal splenic cyst Prenatal Magnetic Resonance imaging (MRI) evolution of fetal splenic cyst (persistence, increasing/decreasing in size, disappearance) 1 year
Secondary Post natal ultrasound evolution at birth of the cyst Post natal ultrasound evolution at birth of the cyst : persistence, increasing/decreasing in size, disappearance 1 year
Secondary Post natal MRI evolution at birth of the cyst Post natal MRI evolution at birth of the cyst : persistence, increasing/decreasing in size, disappearance 1 year
Secondary 1 year ultrasound evolution of the cyst 1 year ultrasound evolution of the cyst : persistence, increasing/decreasing in size, disappearance 1 year
Secondary 1 year MRI evolution of the cyst 1 year MRI evolution of the cyst : persistence, increasing/decreasing in size, disappearance 1 year
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