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临床试验/CTRI/2018/05/013831
CTRI/2018/05/013831已完成不适用

Maternal And Perinatal Outcome in Pregnant Women with Seizure Disorder

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年9月29日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
To study obstetric outcome in women with seizure disorder when compared to women without seizure disorder in terms of maternal complications such as antenatal, intranatal and fetal outcome

研究概览

简要总结

Seizure disorder is a condition characterised by the episode of abnormal, uncontrolled neuronal activity in the brain resulting in various manifestations ranging from dramatic convulsive activity, altered consciousness , abnormal sensations to experiential phenomena not readily discernible by an observer. Epilepsy as described by ILAE 2014 includes atleast 2 unprovoked (or reflex) seizures occurring more than 24 hours apart. Seizure disorder has a prevalence of 1.65% in adults, and every 1 in 200 pregnancies encounters its complications which makes it the second most common neurological problem encountered in pregnancy after headaches. Seizure disorder in reproductive woman could be attributed to idiopathic, trauma, brain tumour, autoantibodies, alcohol withdrawal, cerebrovascular disease, metabolic disorders (uraemia, hepatic failure, electrolyte abnormalities, renal failure, hypoglycaemia, hyperglycaemia). Women with seizure disorder are considered at high risk in pregnancy with maternal mortality 10 times higher than women without seizure disorder. Individual studies provide varied and imprecise estimates of the association between seizure disorder and pregnancy complications such as antenatal (pregnancy induced gestational hypertension, preeclampsia, GDM, miscarriage, APH, preterm delivery, FGR), intranatal (need for induction of labour, caesarean section) , postnatal (PPH), Fetal (low birth weight babies, need for NICU admission, congenital foetal anomalies, still births). Evidence tends to be focussed on foetal harm from in utero exposure to AEDs or on severity of maternal seizures with less emphasis on other pregnancy outcomes. Understanding of the disease and its potential effects on pregnancy is essential for providing appropriate pre pregnancy counselling and optimum management during pregnancy and delivery. Furthermore a vast number of AEDs should be investigated for their teratogenic effects. It was stated that newborns exposed to anti- epileptic drugs (AEDs) in utero have 2–3-fold higher (3.3–9%) prevalence of major congenital abnormalities compared to unexposed newborns. Congenital malformations such as cleft lip and palate, cardiac defects, neural tube defects (NTDs), skeletal abnormalities, and hypospadias have been shown to occur as a result of intrauterine exposure to AEDs. These malformations are observed more frequently with increased doses of AEDs, higher serum levels of AEDs and polytherapeutic approaches.  Folic acid may also be responsible for the occurrence of major complications to some degree as folic acid supplementation in women under anticonvulsant medications has been shown to decrease malformation rates. Therefore, as the outcome of women with seizure disorder in obstetric practice is unclear, in this study we aim to study the obstetric outcome in women with seizure disorder in terms of maternal and perinatal complications and establish whether pregnant women with seizure disorder have an increased risk of complications compared to a control group of matched healthy pregnant women without seizure disorder.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Case- Pregnant women with known case of seizure disorder with first ANC visit between 18-28 weeks Control- Pregnant women without any comorbid condtion.

排除标准

  • Pregnant women with eclpamsia at the time of enrolment.

结局指标

主要结局

To study obstetric outcome in women with seizure disorder when compared to women without seizure disorder in terms of maternal complications such as antenatal, intranatal and fetal outcome

时间窗: 15 months

次要结局

未报告次要终点

研究者

申办方类型
Government medical college

研究点 (1)

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