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      Birth outcomes in pregnant women with epilepsy: A Nationwide multicenter study from Türkiye

      1 , 1 , 2 , 3 , 4 , 1 , 5 , 2 , 2 , 2 , 2 , 2 , 2 , 6 , 7 , 4 , 4 , 8 , 8 , 8 , 9 , 9 , 10 , 10 , 11 , 12 , 12 , 13 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24
      Epilepsia
      Wiley

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          Abstract

          Objective

          The present study was aimed at investigating the effects of anti‐seizure medications (ASMs), patient demographic characteristics, and the seizure type and frequency on the development of congenital malformations (CMs) in the infants of pregnant women with epilepsy (PWWE).

          Methods

          PWWE followed up at the neurology outpatient clinic of 21 centers between 2014 and 2019 were included in this prospective study. The follow‐up of PWWE was conducted using structured, general pregnant follow‐up forms prepared by the Pregnancy and Epilepsy Study Committee. The newborns were examined by a neonatologist after delivery and at 1 and 3 months postpartum.

          Results

          Of the infants of 759 PWWE, 7.2% had CMs, with 5.6% having major CMs. Polytherapy, monotherapy, and no medications were received by 168 (22.1%), 548 (72.2 %), and 43 (5.7 %) patients, respectively. CMs were detected at an incidence of 2.3% in infants of PWWE who did not receive medication, 5.7% in infants of PWWE who received monotherapy, and 13.7% in infants of PWWE who received polytherapy. The risk of malformation was 2.31‐fold (95% confidence interval (CI): 1.48–4.61, p < .001) higher in infants of PWWE who received polytherapy. Levetiracetam was the most frequently used seizure medication as monotherapy, with the highest incidence of CMs occurring with valproic acid (VPA) use (8.5%) and the lowest with lamotrigine use (2.1%). The incidence of CMs was 5% at a carbamazepine dose <700 mg, 10% at a carbamazepine dose ≥700 mg, 5.5% at a VPA dose <750 mg, and 14.8% at a VPA dose ≥750 mg. Thus the risk of malformation increased 2.33 times ( p = .041) in infants of PWWE receiving high‐dose ASMs.

          Significance

          Birth outcomes of PWWE receiving and not receiving ASMs were evaluated. The risk of CMs occurrence was higher, particularly in infants of PWWE using VPA and receiving polytherapy. The incidence of CMs was found to be lower in infants of PWWE receiving lamotrigine.

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          Most cited references41

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          Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.

          Valproate is used for the treatment of epilepsy and other neuropsychological disorders and may be the only treatment option for women of childbearing potential. However, prenatal exposure to valproate may increase the risk of autism. To determine whether prenatal exposure to valproate is associated with an increased risk of autism in offspring. Population-based study of all children born alive in Denmark from 1996 to 2006. National registers were used to identify children exposed to valproate during pregnancy and diagnosed with autism spectrum disorders (childhood autism [autistic disorder], Asperger syndrome, atypical autism, and other or unspecified pervasive developmental disorders). We analyzed the risks associated with all autism spectrum disorders as well as childhood autism. Data were analyzed by Cox regression adjusting for potential confounders (maternal age at conception, paternal age at conception, parental psychiatric history, gestational age, birth weight, sex, congenital malformations, and parity). Children were followed up from birth until the day of autism spectrum disorder diagnosis, death, emigration, or December 31, 2010, whichever came first. Absolute risk (cumulative incidence) and the hazard ratio (HR) of autism spectrum disorder and childhood autism in children after exposure to valproate in pregnancy. Of 655,615 children born from 1996 through 2006, 5437 were identified with autism spectrum disorder, including 2067 with childhood autism. The mean age of the children at end of follow-up was 8.84 years (range, 4-14; median, 8.85). The estimated absolute risk after 14 years of follow-up was 1.53% (95% CI, 1.47%-1.58%) for autism spectrum disorder and 0.48% (95% CI, 0.46%-0.51%) for childhood autism. Overall, the 508 children exposed to valproate had an absolute risk of 4.42% (95% CI, 2.59%-7.46%) for autism spectrum disorder (adjusted HR, 2.9 [95% CI, 1.7-4.9]) and an absolute risk of 2.50% (95% CI, 1.30%-4.81%) for childhood autism (adjusted HR, 5.2 [95% CI, 2.7-10.0]). When restricting the cohort to the 6584 children born to women with epilepsy, the absolute risk of autism spectrum disorder among 432 children exposed to valproate was 4.15% (95% CI, 2.20%-7.81%) (adjusted HR, 1.7 [95% CI, 0.9-3.2]), and the absolute risk of childhood autism was 2.95% (95% CI, 1.42%-6.11%) (adjusted HR, 2.9 [95% CI, 1.4-6.0]) vs 2.44% (95% CI, 1.88%-3.16%) for autism spectrum disorder and 1.02% (95% CI, 0.70%-1.49%) for childhood autism among 6152 children not exposed to valproate. Maternal use of valproate during pregnancy was associated with a significantly increased risk of autism spectrum disorder and childhood autism in the offspring, even after adjusting for maternal epilepsy. For women of childbearing potential who use antiepileptic medications, these findings must be balanced against the treatment benefits for women who require valproate for epilepsy control.
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            Instruction manual for the ILAE 2017 operational classification of seizure types

            This companion paper to the introduction of the International League Against Epilepsy (ILAE) 2017 classification of seizure types provides guidance on how to employ the classification. Illustration of the classification is enacted by tables, a glossary of relevant terms, mapping of old to new terms, suggested abbreviations, and examples. Basic and extended versions of the classification are available, depending on the desired degree of detail. Key signs and symptoms of seizures (semiology) are used as a basis for categories of seizures that are focal or generalized from onset or with unknown onset. Any focal seizure can further be optionally characterized by whether awareness is retained or impaired. Impaired awareness during any segment of the seizure renders it a focal impaired awareness seizure. Focal seizures are further optionally characterized by motor onset signs and symptoms: atonic, automatisms, clonic, epileptic spasms, or hyperkinetic, myoclonic, or tonic activity. Nonmotor-onset seizures can manifest as autonomic, behavior arrest, cognitive, emotional, or sensory dysfunction. The earliest prominent manifestation defines the seizure type, which might then progress to other signs and symptoms. Focal seizures can become bilateral tonic-clonic. Generalized seizures engage bilateral networks from onset. Generalized motor seizure characteristics comprise atonic, clonic, epileptic spasms, myoclonic, myoclonic-atonic, myoclonic-tonic-clonic, tonic, or tonic-clonic. Nonmotor (absence) seizures are typical or atypical, or seizures that present prominent myoclonic activity or eyelid myoclonia. Seizures of unknown onset may have features that can still be classified as motor, nonmotor, tonic-clonic, epileptic spasms, or behavior arrest. This "users' manual" for the ILAE 2017 seizure classification will assist the adoption of the new system.
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              Comparative safety of antiepileptic drugs during pregnancy.

              To assess the safety of the newer antiepileptic drugs (AEDs) during pregnancy. The study population was pregnant women who enrolled in the North American AED Pregnancy Registry between 1997 and 2011. Data on AED use and maternal characteristics were collected through phone interviews at enrollment, at 7 months' gestation, and postpartum. Malformations were confirmed by medical records. The risk of major malformations was calculated among infants exposed to specific AEDs in monotherapy during the first trimester of pregnancy and among an unexposed group. Risk ratios (RRs) and 95% confidence intervals (CIs) were estimated with logistic regression. The risk of major malformations was 9.3% (30 of 323) for valproate, 5.5% (11 of 199) for phenobarbital, 4.2% (15 of 359) for topiramate, 3.0% (31 of 1.033) for carbamazepine, 2.9% (12 of 416) for phenytoin, 2.4% (11 of 450) for levetiracetam, and 2.0% (31 of 1,562) for lamotrigine. Compared with lamotrigine, the RR was 5.1 (95% CI 3.0-8.5) for valproate, 2.9 (1.4-5.8) for phenobarbital, and 2.2 (1.2-4.0) for topiramate. The proportion of women with epilepsy who had seizures during pregnancy ranged from 23% for valproate to 31% for lamotrigine. Valproate was associated with a higher risk of neural tube defects, hypospadias, cardiac defects, and oral clefts and phenobarbital with a higher risk of cardiac defects and oral clefts; 5 infants exposed to topiramate (1.4%) had a cleft lip. AEDs such as valproate and phenobarbital were associated with a higher risk of major malformations than newer AEDs such as lamotrigine and levetiracetam. Topiramate was associated with an increased risk of cleft lip compared with that of a reference population.
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                Journal
                Epilepsia
                Epilepsia
                Wiley
                0013-9580
                1528-1167
                September 2023
                July 14 2023
                September 2023
                : 64
                : 9
                : 2310-2321
                Affiliations
                [1 ] Department of Neurology Çukurova University School of Medicine Adana Türkiye
                [2 ] Department of Neurology University of Health Sciences, Bakırkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Hospital Istanbul Türkiye
                [3 ] Department of Neurology Koç University School of Medicine İstanbul Türkiye
                [4 ] Department of Neurology Istanbul University–Cerrahpasa School of Medicine Istanbul Türkiye
                [5 ] Department of Neurology University of Health Sciences, Ankara Training and Research Hospital Ankara Türkiye
                [6 ] Department of Neurology University of Health Sciences, Antalya Training and Research Hospital Antalya Türkiye
                [7 ] Department of Neurology Antalya Training and Research Hospital Antalya Türkiye
                [8 ] Department of Neurology Istanbul University School of Medicine Istanbul Türkiye
                [9 ] Department of Neurology Uludag University School of Medicine Bursa Türkiye
                [10 ] Department of Neurology University of Health Sciences, Haydarpasa Numune Training and Research Hospital Istanbul Türkiye
                [11 ] Department of Neurology Karadeniz Technical University School of Medicine Trabzon Türkiye
                [12 ] Department of Neurology Osmangazi University School of Medicine Eskisehir Türkiye
                [13 ] Department of Neurology Hacettepe University School of Medicine Ankara Türkiye
                [14 ] Department of Neurology Akdeniz University School of Medicine Antalya Türkiye
                [15 ] Department of Neurology Adnan Menderes University School of Medicine Aydın Türkiye
                [16 ] Department of Neurology İnönü University Turgut Özal Medical Center Training and Research Hospital Malatya Türkiye
                [17 ] Department of Neurology University of Health Sciences, Umraniye Training and Research Hospital Istanbul Türkiye
                [18 ] Department of Neurology Sanko University Faculty of Medicine Gazıantep Türkiye
                [19 ] Department of Neurology Erzincan Binali Yildirim University School of Medicine Erzincan Türkiye
                [20 ] Department of Neurology University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital Istanbul Türkiye
                [21 ] Department of Neurology University of Health Sciences, Bezm‐i Alem Valide Sultan Vakif Gureba Training and Research Hospital Istanbul Türkiye
                [22 ] Department of Neurology Mugla Sıtkı Kocman University School of Medicine Muğla Türkiye
                [23 ] Department of Neurology University of Health Sciences, Gaziosmanpasa Training and Research Hospital Istanbul Türkiye
                [24 ] Department of Biostatistics Çukurova University School of Medicine Adana Türkiye
                Article
                10.1111/epi.17692
                d3f1ba78-44fa-4804-83cc-47ebe6bd0773
                © 2023

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