Efficacy of the Combination of Acetylsalicylic Acid and L-arginine to Prevent Preeclampsia in Pregnant High Risk
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of preeclampsia
研究概览
简要总结
Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher in developing countries than in developed (2.8% and 0.4%). In Mexico it is estimated that preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality. Because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so far there is no effective treatment to decrease the morbidity and mortality of this entity, so it is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in addition to the information the investigators have reduced the effect of these strategies on arterial stiffness; Moreover, it has been observed that L-arginine lowers blood pressure in this population. It is for this that is of interest to know the efficacy and safety of the combination of L-arginine low dose, which is known as an important eNOS in NO production substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the prevention of preeclampsia and also determine their effect on arterial stiffness as a noninvasive method, as is the applanation tonometry.
详细描述
It will conduct a clinical trial, double-blind, randomized and placebo control group female patients with 12 weeks of gestation have one or more risk factors for developing preeclampsia. 2 groups will be formed with 82 patients each, chance will determine the intervention (acetylsalicylic + L-arginine acetylsalicylic acid or acid + placebo). At the beginning and end of the intervention clinical and laboratory determinations, the end will be determined in both groups the incidence of preeclampsia, severity and number needed to treat is made. The data obtained were analyzed using SPSS statistical software version 22. It was considered statistically significant at p <0.05.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant before 12 weeks of gestation
- •High risk of preeclampsia
- •Signature of informed consent in writing
排除标准
- •Noncompliance > 20% of drug intake
- •Lack of tolerability L-arginine or acetylsalicylic acid
- •Compliance with at least one non-inclusion criteria during the course of the study
- •Serious adverse event
- •Withdrawal of consent
研究组 & 干预措施
acetylsalicylic acid and L-arginine
acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and L-arginine 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination
干预措施: L-arginine (Drug)
acetylsalicylic acid and L-arginine
acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and L-arginine 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination
干预措施: acetylsalicylic acid (Drug)
acetylsalicylic acid and placebo
acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and placebo 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination
干预措施: Placebo (for L-arginine) (Drug)
acetylsalicylic acid and placebo
acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and placebo 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination
干预措施: acetylsalicylic acid (Drug)
结局指标
主要结局
Incidence of preeclampsia
时间窗: from 20 weeks gestation until 37 weeks
severity of preeclampsia
时间窗: from 20 weeks gestation until 37 weeks
次要结局
- Acute myocardial infarction maternal(at week 37)
- Mean blood pressure maternal(from 12 weeks gestation until 37 weeks)
- Pulse wave velocity maternal(from 12 weeks gestation until 37 weeks)
- Pulmonary edema maternal(at week 37)
- Coagulopathy maternal(at week 37)
- Retinal damage maternal(at week 37)
- Fetal mortality(birth)
- Stroke maternal(at week 37)
- Acute respiratory distress syndrome maternal(at week 37)
- maternal mortality(at week 37)
- Birth weight(birth)
- systolic blood pressure maternal(from 12 weeks gestation until 37 weeks)
- diastolic blood pressure maternal(from 12 weeks gestation until 37 weeks)
- Renal failure maternal(at week 37)
- Intrauterine growth restriction(birth)
- Adverse effects maternal(from 12 weeks gestation until 37 weeks)
研究者
Leonel Garcia Benavides
PhD
University of Guadalajara