Vitamin D Status in Pregnant Women With Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,173
- 试验地点
- 1
- 主要终点
- Vitamin D (25OHD) status in the first trimester
研究概览
简要总结
Hypothesis : Vitamin D serum concentration is decreased in the first trimester in pregnant women who will develop preeclampsia in the second or third trimester compare to a control group Primary purpose : To determine the vitamin D status in the first trimester in a large population of french pregnant women in order to evaluate the importance of the vitamin D deficiency in France and correlate this deficiency with preeclampsia
详细描述
Primary purpose : To compare the vitamin D (25OHD) status, in the first trimester, in a group of patients with preeclampsia and a group of pregnant women without preeclampsia.
Secondary purpose : (i)To compare the vitamin D status in the third trimester in a group of patients with preeclampsia and a group of pregnant women without preeclampsia. (ii) To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area. (iii) To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D 100000U at 28 weeks Methodology : Multicenter (6 centers), Cohort, Nested case-control study Protocol : 4500 patients will be recruited. A blood sample will be performed : in the first trimester (11-14 weeks), in the third trimester (28-40 weeks), and cord blood. For each patient with preeclampsia, 4 controls will be taken from the cohort and matched by parity, race/ethnicity, maternal age, season, BMI. The serum concentration of 25OHD will be measured in all samples.A dosage of 25OHD will be performed in 1000 women from the initial cohort in order to calculate the prevalence of vitamin D deficiency.
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
- •Pregnant woman
- •First trimester
- •Singleton
- •Affiliated to Social security policy
- •Woman who gave informed consent
排除标准
- •Hypercalcemia (>2.65 mmol/l) or any other phosphocalcic disease
- •Hypertension (>140/90) from the first trimester
- •Renal insufficiency (creatinine > 120µmol/l)
- •Bone disease (osteogenesis imperfecta…)
- •Lithium therapy
- •Bowel malabsorption
- •Kidney stones
结局指标
主要结局
Vitamin D (25OHD) status in the first trimester
时间窗: 11-14 (+6) weeks of amenorrhea
To compare the vitamin D (25OHD) status, in the first trimester, in a group of patients with preeclampsia and a group of pregnant women without preeclampsia
次要结局
- Deficit un vitamin D(11-14 (+6) weeks of amenorrhea)
- Vitamin D status in the third trimester(28-40 weeks of amenorrhea)
- Calcemia of the newborns(1 day (At the moment of the Guthrie test))