NCT03407807

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

October 25, 2017

Last Update Submit

January 15, 2018

Conditions

Pregnant Women

Keywords

Fetal Splenic cystDifferential DiagnosisEvolution and complication

Outcome Measures

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

    1 day

Secondary Outcomes (5)

  • Prenatal Magnetic Resonance imaging (MRI) evolution of fetal splenic cyst

    1 year

  • Post natal ultrasound evolution at birth of the cyst

    1 year

  • Post natal MRI evolution at birth of the cyst

    1 year

  • 1 year ultrasound evolution of the cyst

    1 year

  • 1 year MRI evolution of the cyst

    1 year

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnent women with an isolated suspected fetal splenic cyst

You may qualify if:

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

You may not qualify if:

  • All others fetal diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

January 23, 2018

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

January 23, 2018

Record last verified: 2017-10

Locations

FR(1)