Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome
UDiPPP
2 other identifiers
interventional
46
1 country
1
Brief Summary
The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedStudy Start
First participant enrolled
October 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 29, 2026
February 1, 2023
2 months
September 15, 2022
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postnatal child development
composite criterion as follows: Delayed acquisition is defined according to the standards of the Pediatric Society: age of sitting \> 8 months, age of walking \> 18 months, ability or not to associate 3 words at age 3. The use of a medical profession concerns follow-up by a speech therapist, a psychomotrician or a physiotherapist. It is not necessarily a periodic follow-up but a minimum of 2 consultations after the "assessment" consultation. The scoring defines 2 groups, * children with 0 points considered with a "normal" post-natal development * children with 1 point or more considered with a post-natal development disorder.
Baseline
Secondary Outcomes (2)
mother's medical history
Baseline
medical history of the child
Baseline
Study Arms (1)
questionnaire
EXPERIMENTALQuestionnaire on postnatal development
Interventions
Eligibility Criteria
You may qualify if:
- Adult patient diagnosed with a periventricular cyst during a prenatal ultrasound at Bordeaux University Hospital between January 1, 2016 and December 31, 2020.
- Patient affiliated with or benefiting from a social security plan.
- Oral informed consent.
You may not qualify if:
- Subarachnoid cyst
- Blake's pouch cyst
- Choroid plexus cyst
- Periventricular leukomalacia
- Poor understanding of French
- Patient under legal protection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Bordeaux
Bordeaux, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 21, 2022
Study Start
October 12, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
May 29, 2026
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share