Effects of Probiotic Supplementation During Pregnancy on Maternal and Infant Outcomes in Preeclampsia High-risk Groups Based on Abnormal Intestinal Flora: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 338
- 主要终点
- The incidence of preeclampsia
研究概览
简要总结
In this randomized controlled study, preventive intervention of aspirin combined with probiotics or aspirin combined with placebo would given to PE (pre-eclampsia) high-risk population with gut microbiota dysbiosis during their pregnancy, and finally assess the efficacy and safety of aspirin combined with probiotics to prevent PE.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PE high-risk population aged 18-50 years with gut microbiota dysbiosis
- •No severe cardiopulmonary diseases
- •No severe hepatic and renal insufficiency
- •No severe active infection
- •Pregnant women did not take antibiotics or antifungal drugs 30 days before fecal sample collection; No probiotic preparation was taken 2 weeks before sample collection; Never take drugs that may interfere with glucose and lipid metabolism
- •No diseases affecting intestinal microecology
- •No history of smoking and drinking
- •The researchers evaluated those pregnant women expected to deliver more than 20 weeks
- •Voluntarily participate in this clinical study and sign the informed consent form
排除标准
- •With severe cardiopulmonary, hepatic and renal insufficiency
- •With uncontrolled active infections 2 weeks before enrollment
- •Subjects took antibiotics or antifungal drugs 30 days before sample collection; Take probiotics 2 weeks before sample collection; Have taken drugs that may interfere with glucose and lipid metabolism
- •with diseases affecting intestinal microecology
- •Smoking and drinking history
- •With acute gastrointestinal ulcer
- •Hemorrhagic constitution
- •Other discomfort assessed by the investigato
结局指标
主要结局
The incidence of preeclampsia
时间窗: From being recruited to 6 weeks after delivery
After 20 weeks of pregnancy, systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90mmHg, accompanied by any of the following items: urinary protein ≥ 0.3g/24h, or urinary protein / creatinine ratio ≥ 0.3,or random urinary protein ≥ (+) (examination method for unconditional protein quantification); Non-albuminuria can be accompanied by any kind of organ or system involvement: heart, lung, liver, kidney and other important organs, or abnormal changes in blood system, digestive system, nervous system, placenta-fetus, etc.
次要结局
- The incidence of fetal growth restriction(From being recruited to 6 weeks after delivery)