Isolated Fetal Splenic Cyst : Prenatal Diagnosis and Postnatal Evolution

Pregnant Women Clinical Trial

Official title:

Isolated Fetal Splenic Cyst : Prenatal Diagnosis and Postnatal Evolution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407807
• Other study ID #: RECHMPL17_0331
• 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
• 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

Related Conditions & MeSH terms

• Pregnant Women

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