An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case report, a 28-year-old woman developed placental delayed villous maturation (DVM) and impaired placenta blood flow due to chorionic thrombosis following methadone maintenance therapy during pregnancy. The woman delivered a stillborn female fetus at 39 weeks of gestation. The cause of fetus death was considered as hypoxic-ischaemic encephalopathy along with chronic fetal methadone intoxication, placental DVM and impaired placenta blood flow due to chorionic thrombosis following in-utero exposure of methadone [time to reactions onsets not stated].
The woman was receiving methadone maintenance therapy at 80 mg/day during the pregnancy. Her therapy with methadone was discontinued 15 days before delivery. Prior to the delivery, the woman was admitted because fetal movements...
- Montanari E, et al. Toxicological and histological analyses for a stillborn delivered by a mother under methadone maintenance therapy. Forensic Toxicology 36: 514-524, No. 2, Jul 2018. Available from: URL: http://doi.org/10.1007/s11419-017-0402-9 - Italy