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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A male neonate and a female fetus developed fetal valproate syndrome following in-utero exposure to valproate or valproate and lamotrigine, given for the treatment of maternal epilepsy [maternal routes not stated].
Case 1: The mother of the male neonate was hospitalised to perinatal centre due to cervical insufficiency at 21+2 weeks of gestation. She was diagnosed with epilepsy in childhood, for which she had been receiving therapy with valproate 3 × 600 mg/day along with prophylactic folic acid 2 × 0.4 mg/day. Differentiated ultrasound showed normal fetal growth without any signs of associated anomalies. At 25+2 weeks of gestation, due to preterm labour resulting in a rupture of membranes, a caesarian section was performed and a male neonate was delivered with an Apgar score...
- Wiedemann K, et al. Fetal Valproate Syndrome - Still a Problem Today!. Zeitschrift fur Geburtshilfe und Neonatologie 221: 243-246, No. 5, 2017. Available from: URL: http://doi.org/10.1055/s-0043-107619 - Germany