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临床试验/NCT01806454
NCT01806454Unknown不适用

Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China: a Multi-center, Prospective Random Trial

West China Second University Hospital0 个研究点目标入组 11,000 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
11,000
主要终点
incidence of pre-eclampsia

研究概览

简要总结

the purpose of this study is to determine whether calcium supplementation is effective to prevent preeclampsia in Sichuang Province of china and which dose is more suitable

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

性别
Female
接受健康志愿者

入选标准

  • Nulliparity;age ≥35 years;Previous pre-eclampsia;Family history of pre-eclampsia;Multiple pregnancy;Time between pregnancies ≥10years;Body mass index ≥25;diastolic pressure ≥ 80 mm Hg before 20 weeks' gestation;Proteinuria ≥+ on more than one occasion or ≥ 300 mg/24 h before 20 weeks' gestation;Underlying medical conditions(Pre-existing hypertension;Pre-existing renal disease;Pre-existing diabetes;Presence of antiphospholipid antibodies;Chronic autoimmune disease);male sex partner's predecessor wife has Previous pre-eclampsia

排除标准

  • first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )

研究组 & 干预措施

calcium A

Active Comparator

tablets, 600mg per day,till birth

干预措施: calcium (Drug)

calcium B

Active Comparator

tablets,1200mg per day,till birth

干预措施: calcium (Drug)

结局指标

主要结局

incidence of pre-eclampsia

时间窗: postpartum forty-two days

次要结局

未报告次要终点

研究者

发起方
West China Second University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinghui Liu

Professor

West China Second University Hospital

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