Antiepileptic drug use among women from the Taiwanese Registry of Epilepsy and Pregnancy: Obstetric complications and fetal malformation outcomes

To investigate antiepileptic drugs (AEDs) prescription and pregnancy outcomes in pregnancies with epilepsy in Taiwan between 2004 and 2015. We retrospectively reviewed data from the Taiwanese Registry of Epilepsy and Pregnancy (TREP). The TREP registry is a voluntary prospective cohort registry, which tracks pregnant women with epilepsy and AED prescription throughout pregnancy, delivery, and early childhood development. All TREP pregnancies (n = 318) that had completed questionnaires up until delivery or had had an unsuccessful pregnancy were analyzed. Over 94.7% of women had been prescribed AEDs during pregnancy, with 69.0% and 25.7% having received monotherapy, or polytherapy, respectively. Among live births, 12 (3.9%) reported malformation. Cesarean section rate was reported higher than usual (54.5%). In 2004, 73.3% of AEDs prescribed were 1st generation, with 1st generation prescription rates falling to only 8.3% of total prescribed in 2015. AED polytherapy also fell during the study period (40.0% to 20.0%). Cesarean sections were found to be higher for women over 35 years, who had generalized epilepsy, or had experienced an obstetric complication during pregnancy term. Binary logistic regression revealed that Cesarean section was associated with maternal complications (OR = 5.11, CI 95% = 1.11–23.51, p = 0.036), while malformations were associated with obstetric complication (OR = 20.46, CI 95% = 4.80–87.21, pst generation AEDs and proportion of patients receiving polytherapy over the study period. Obstetric complications were associated with Cesarean section. Fetal malformations were significantly associated with obstetric complications. AED risk factors were not significantly associated with either complications or malformations.本研究旨在调查2004年至2015年间中国台湾地区癫痫孕妇的抗癫痫药物（antiepileptic drugs, AEDs）处方情况与妊娠结局。本研究回顾性分析了台湾癫痫与妊娠登记系统（Taiwanese Registry of Epilepsy and Pregnancy, TREP）的数据。该登记系统为自愿参与的前瞻性队列登记库，全程追踪癫痫孕妇的抗癫痫药物处方、妊娠、分娩及幼儿发育情况。本研究共纳入截至分娩时完成问卷或妊娠失败的318例TREP登记妊娠病例进行分析。逾94.7%的孕妇在妊娠期接受了抗癫痫药物处方，其中69.0%采用单药治疗，25.7%采用多药联合治疗。活产儿中，共12例（3.9%）出现先天畸形。剖宫产（Cesarean section）率高于常规水平，达54.5%。2004年，73.3%的抗癫痫药物处方为第一代药物，至2015年，第一代药物的处方占比仅降至8.3%。研究期间，抗癫痫药物多药联合治疗的占比也呈下降趋势，从40.0%降至20.0%。年龄超过35岁、患有全面性癫痫或妊娠期出现产科并发症的孕妇，其剖宫产率更高。二元logistic回归分析显示，剖宫产与产妇并发症相关（比值比odds ratio, OR=5.11，95%置信区间confidence interval, CI=1.11–23.51，p=0.036），而先天畸形与产科并发症相关（比值比OR=20.46，95%置信区间CI=4.80–87.21，p<0.001）。进一步分析表明，研究期间分娩孕周更低、产妇年龄更高、使用第一代抗癫痫药物及多药联合治疗比例更高与剖宫产相关。产科并发症与剖宫产相关。胎儿先天畸形与产科并发症显著相关。抗癫痫药物相关风险因素与并发症或先天畸形均无显著关联。