Barbesaclone (Epilepsy = All indications)

Study Type of data Exposure measurement Outcome assessment Adjustment
Battino (Barbexaclone) (Epilepsy), 2024 prospective cohort Reporting physicians collected information on drug therapy after each trimester. Abnormalities in the offspring were recorded descriptively by reporting physicians. A committee blinded to type of exposure assessed and categorized these abnormalities. When necessary, the committee solicited additional information from the reporting physicians. Exclusion of pregnancies exposed to known teratogenic drugs, and those with comorbidities associated with teratogenic risks. No adjustment for this group of comparison.
Canger (Barbesaclone), 1999 prospective cohort The patients received monthly obstetric and neurologic examinations, and antiepileptic drug blood levels were tested monthly. At the time of delivery the infants underwent a standardized examination by a pediatrician, and a more detailed clinical examination on day 5 in San Paolo Hospital only and during the first months in other hospitals (if so medical records were also acquired). None.

master protocol