Prospective observational study of the influence of various antiepileptic drugs on pregnancy and infant development

Prospective observational study of the influence of various antiepileptic drugs on pregnancy and infant development - Prospective observational study of the influence of various antiepileptic drugs on pregnancy and infant development(JES-AEDs-PG)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034135

Enrollment

400

Registered

2018-10-09

Start date

2018-08-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Pregnant women with epilepsy (2) Pregnant women with unknown outcome of pregnancy (abortion, miscarriage, stillbirth, birth) at the time of consent

Exclusion criteria

Exclusion criteria: (1) Those judged as inappropriate for participation in this study by the principal investigator/sub-investigators

Design outcomes

Primary

Measure	Time frame
Incidence rate of malformation (shall be evaluated by single and multidrug administration respectively. When the number of cases that can be statistically processed is registered, examinations by dosage and blood concentration for each antiepileptic drug will be performed.)	—

Secondary

Measure	Time frame
Outcome after pregnancy (spontaneous abortion, stillbirth, perinatal death, birth) Oral antiepileptic drug Blood concentration of oral antiepileptic drug Maternal seizure Folic acid amount in blood Incidence rate of malformation Health condition of infants Breastfeeding	—

Countries

Japan

Contacts

Public ContactHideyuki Ohtani

National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders Division of clinical Research,Pediatrics

h-ohtani@shizuokamind.org054-245-5446

Outcome results