Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- efficacy of L arginine to prevent preeclampsia
研究概览
简要总结
Randomized double-blind controled clinical trial to assess the efficacy and safety of L-arginine to prevent preeclampsia.
applied to pregnant women with risk factors for preeclampsia. the main result was the development of preeclampsia as well as side effects to taking l arginine besides perinatal outcomes
详细描述
Two groups were formed. one received L arginine 3 grams orally at day from the 20th week of pregnancy. the other group received placebo.
Each three weeks were evaluated in search of high blood pressure and proteinuria.
The follow-up was until the end of pregnancy and two weeks after this
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •one or more risk factors for developing preeclampsia (nulliparous, previous history of preeclampsia, chronic hypertension, BMI ≥30)
排除标准
- •pregnant women carriers of chronic renal failure
- •pre gestational diabetes
- •multiple pregnancy and were removed for some reason they received medication that would interfere with the interpretation of results (aspirin)
结局指标
主要结局
efficacy of L arginine to prevent preeclampsia
时间窗: from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks.
number of patients with diagnosis of preeclampsia. the diagnostic was performed when they presented arterial blood pressure above 140/90 mm / Hg in the span of 6 hours and accompanied by proteinuria (\>300 milligrams in one sample) number of patients with high blood pression and proteinuria (ACOG criteria) The evaluations were performed every three weeks until week 31, then every two weeks until week 35 and weekly until pregnancy ended
次要结局
- safety of L arginine(from time of randomization until birth approximalety 18 weeks)
- perinatal outcome(from time to delivery until two weeks after, approximalety 18 weeks)
研究者
Eva Elizabet Camarena Pulido
MD
Hospital Civil Juan I. Menchaca