Testing the Effect of a Dietary Intervention Program on the Incidence of Pre-eclampsia in Women at Risk
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- lower incidence of pre-eclampsia during pregnancy
研究概览
简要总结
Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and dietary status have been suggested to play a role in development of preeclampsia. Low intake of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3 ratio and high calories consumption are possible risk factors.
Material and Methods: A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented.
In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.
详细描述
Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and dietary status have been suggested to play a role in development of preeclampsia. Low intake of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3 ratio and high calories consumption are possible risk factors.
Material and Methods
A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented.
In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •high risk of preeclampsia
排除标准
- •age below 18
- •low risk of preeclampsia
研究组 & 干预措施
supplement and balanced diet
Woman at high risk of pre-eclampsia:
supplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet.
干预措施: balanced diet (Behavioral)
women without nutrition or supplement intervention
usual follow-up in the gynecology out patient clinic, without nutrition or supplement intervention.
supplement and balanced diet
Woman at high risk of pre-eclampsia:
supplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet.
干预措施: 1500 mg Calcium and 1200 IU Vitamin D for 2 months (Dietary Supplement)
结局指标
主要结局
lower incidence of pre-eclampsia during pregnancy
时间窗: up to 42 weeks gestation
lower incidence of pre-eclampsia post-partum
时间窗: 4 weeks post delivery
次要结局
未报告次要终点