The Maternal-fetal Gradient of Free and Esterified Phytosterols in Term Human Pregnancy at Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 主要终点
- Free and esterified phytosterol ratio
研究概览
简要总结
Total plasma cholesterol rises by 60 % with progressing pregnancy in humans. Because lipid-lowering drugs are contraindicated during pregnancy, natural compounds, such as phytosterols, may be a safe and effective alternative to prevent undesirable effects. Information on phytosterols in pregnancy is so far very limited. To date, to the best of our knowledge, no studies have characterized the maternal-fetal gradient of free and esterified phytosterols in full-term human pregnancy. For this purpose, maternal and cord blood cholesterol and non-cholesterol sterol (campesterol, stigmasterol, sitosterol) concentrations were measured in term pregnant women at delivery by using gas chromatography-mass spectrometry.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A single pregnancy
- •A gestational age determined from known last maternal menstrual period higher than 37 weeks
- •A normal diet without phytosterol supplementation during pregnancy
- •Written informed consent available.
排除标准
- •Major congenital anomalies
- •Maternal history of cardiovascular disease
- •Endocrine disorders such as diabetes, hypercholesterolemia, pre-eclampsia, thyroid or adrenal problems
- •Clinical chorioamnionitis
结局指标
主要结局
Free and esterified phytosterol ratio
时间窗: the day of delivery
Plasma free and esterified phytosterol concentrations will be measured in mother-cord blood pairs at delivery. Plasma phytosterol concentrations will be the sum of plasma campesterol, stigmasterol and sitosterol concentrations (mg/L). Gas chromatography-mass spectrometry will be used for measurements.
次要结局
- total cholesterol concentrations(the day of delivery)
- total 7-alpha-hydroxycholesterol concentrations(the day of delivery)
- total lathosterol concentrations(the day of delivery)
- total 7-dehydrocholesterol concentrations(the day of delivery)
- fatty acid concentrations(the day of delivery)
研究者
Virgilio Paolo Carnielli
MD, Phd, Professor of Neonatal Pediatrics
Università Politecnica delle Marche