NCT00585702已完成不适用
Antimanic Drug Use in Pregnancy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- SIGH-ADS
研究概览
简要总结
The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. Participation in the study includes 7 study visits, three in pregnancy and four postpartum.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
SIGH-ADS
时间窗: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Mania Rating Scale
时间窗: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Bayley Scales of Infant Development
时间窗: 12, 28, 52 weeks postpartum
次要结局
- Nutritional Blood Levels(20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum)
- Weight gain in pregnancy(20,30,36 weeks gestation)
- Infant physical exam(2,12,28,52 weeks post delivery)
- Structured Clinical Interview for DSM-IV(20 weeks gestation at enrollment)
- Maternal Functioning and Gratification(2, 12, 28, 52 weeks postpartum)
研究者
Katherine Wisner
Professor of Psychiatry
University of Pittsburgh
研究点 (1)
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