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CompletedNCT03407807Updated Jan 23, 2018

Isolated Fetal Splenic Cyst : Prenatal Diagnosis and Postnatal Evolution

An observational study in Pregnant Women, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,450
Ages
18 Years and older
Sex
Female
01

Study 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

Read the detailed 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.

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Conditions studied

  • Pregnant Women

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Keywords

  • Fetal Splenic cyst
  • Differential Diagnosis
  • Evolution and complication
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Pregnent women with an isolated suspected fetal splenic cyst

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • All others fetal diagnosis
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,450 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Prenatal ultrasound evolution of fetal splenic cysts during pregnancy

    Prenatal ultrasound evolution of fetal splenic cysts during pregnancy: persistence, increasing/decreasing in size, disappearance

    Time frame: 1 day

Secondary outcomes

  1. 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)

    Time frame: 1 year

  2. Post natal ultrasound evolution at birth of the cyst

    Post natal ultrasound evolution at birth of the cyst : persistence, increasing/decreasing in size, disappearance

    Time frame: 1 year

  3. Post natal MRI evolution at birth of the cyst

    Post natal MRI evolution at birth of the cyst : persistence, increasing/decreasing in size, disappearance

    Time frame: 1 year

  4. 1 year ultrasound evolution of the cyst

    1 year ultrasound evolution of the cyst : persistence, increasing/decreasing in size, disappearance

    Time frame: 1 year

  5. 1 year MRI evolution of the cyst

    1 year MRI evolution of the cyst : persistence, increasing/decreasing in size, disappearance

    Time frame: 1 year

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Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
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Registry details

Key details

Study ID
NCT03407807
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Jan 2017
Primary completion
Mar 2017
Completion
Sep 2017
Last update
Jan 23, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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