Comparison of Monoamines Oxidases A and B Activities and the Metabolism of Nicotine in Smoking and Nonsmoking Pregnant Women and in Their Newborns. Evaluation of Their Effects on the Newborns' Behavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 主要终点
- monoamine oxidase markers
研究概览
简要总结
Smoking substantially inhibits the activities of both monamine oxidase (MAO) A and B enzymes.
Aims of this study: to compare MAO activities and nicotine and cotinine in peripheral blood of smoking and nonsmoking pregnant women, in their placenta and in cord blood and relate them with the behavior of their newborns being observed during 48 hours after birth.
详细描述
40 pregnant smoking and 40 pregnant nonsmoking women will be included at the end of the 2nd trimester.
Assessments: smoking characteristics, plasma cotinine, DHPG, DOPAC, 5HIAA concentrations reflecting MAOA activity and platelet MAOB activity will be measured just after inclusion (end of 2nd trimester), just before delivery in venous maternal blood and just after delivery in cord blood.
The newborns' behavior (wellbeing) will be assessed every 8 hour after birth for 2 days.
Comparisons will be made between smoking and nonsmoking women and their newborns.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnancy of 5 or 6 months
- •nonsmokers: lifetime smoking of less than 100 cigarettes; smokers: unable to stop smoking during the first 3 months of pregnancy; smoking at least 10 cigarettes/day.
排除标准
- •pathological pregnancies
- •opioid dependence; alcoholism.
- •chronic psychiatric, hematological, neurological disorders
- •eclampsia
- •chronic antidepressant or neuroleptic treatment
- •current nicotine replacement therapies
结局指标
主要结局
monoamine oxidase markers
时间窗: at birth
次要结局
未报告次要终点