Agenesis of the Corpus Callosum
Conditions
Keywords
agenesis, corpus callosum, prenatal diagnosis
Brief summary
The purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.
Detailed description
Agenesis of the corpus callosum is the most frequent brain malformation. This anomaly may be diagnosed by ultrasound screening. In half of these prenatal cases, the anomaly seems to be isolated. In this setting, there are no prospective data concerning the development of these children, preventing any clear information to be delivered to parents. Prenatal diagnostic centers therefore face extremely variable rates of termination of pregnancies (TOP), which can reach up to 80%. This is a multicentric prospective interventional study whose primary objective is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum. Evaluation at three years will include Intellectual Quotient (IQ) quantification using the WPPSI-III, 3rd edition of Wechsler Preschool and Primary Scale of Intelligence and evaluation of intra-hemispheric coordination using the Vineland adaptative behaviour scale. Secondary objectives will include: * Circumstances leading to the prenatal diagnosis of agenesis of the corpus callosum * Causes leading to termination of pregnancies * Determination of criteria allowing to confirm that agenesis of the corpus callosum is isolated (family history, imagery, genetics) These results could allow to determine the optimal prenatal management of such cases.
Interventions
OTHERPsychometric scales for infants at 3 years of age
WPPSI-III, VINELAND, CBCL, NEPSY
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women from 28 weeks of gestation * Complete agenesis of the corpus callosum * Partial agenesis of the corpus callosum * Abnormal corpus callosum (size, anatomy) As diagnosed by an expert ultrasound fetal brain examination.
Exclusion criteria
* age \< 18 years old * women who do not understand french * women not covered by the French social security system * refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WPPSI-III (wechsler preschool and primary scale of intelligence) :evaluation of intellectual quotient ( questionnaire) | 3 years | Neurodevelopment outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vineland adaptative behaviour scales (motricity capacity) : questionnaire | 3 years | Neurodevelopment outcome |
| Nepsy : developmental neuropsychological assessment (capacity of coordination) | 3 years | Neurodevelopment outcome |
| CBCL: Child Behavior Checklist (behaviour) : self administered questionnaire | 3 years | Neurodevelopment outcome |
| Cerebral abnormalities | up to 3 years | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean-Marie Jouannic, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed