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Pharmacokinetic and Placental Transfer of Levetiracetam
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Hypotheses: The treatment of epilepsy during pregnancy is difficult because of the risk of anti-epileptic drugs on the one hand and the risk of destabilization of epilepsy in the mother on the other hand. There is limited data on the pharmacokinetics (concentration study) and pharmacodynamics (efficacy and toxicity effects study) of levetiracetam in pregnant women. The few studies focus on few women and show very strong interindividual variability and a tendency to decrease total concentrations. Main objective: To develop a population pharmacokinetic model of levetiracetam during pregnancy. After the study, this model could be used to propose dose adjustments to maintain stable concentrations in pregnant women throughout pregnancy. Secondary objectives: * Describe placental transfer during childbirth and during a medical termination of pregnancy * Link the concentration and its variation in the individual to the effects of treatment
Official title: Study of Maternal Pharmacokinetic and Placental Transfer of Levetiracetam
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2022-04-20
Completion Date
2023-08-16
Last Updated
2026-07-01
Healthy Volunteers
No
Conditions
Interventions
biological collection
Blood collection at each trimester of pregnancy, delivery and post partum visit or at medical interruption. Collection of saliva at each trimester of pregnancy and post partum visit. Collection of cord blood and amniotic fluid at delivery or at medical interruption.
Locations (1)
hospital Cochin
Paris, France