NCT00466622已完成3 期
Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pulsatility index of the uterine artery
研究概览
简要总结
FlowMet study is a "sub-study" of the PregMet study (registered in 2005).
The aim of the FlowMet study is to register the possible effect of metformin on the blood flow of the uterine artery in pregnant PCOS women. The participants will be examined with ultrasound Doppler in gestational week 10-13:
- before and 3h after the first tablet intake of metformin/placebo
- and 10-14 days after inclusion in the trial
- blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Same as in the PregMet study. As this study is a sub-study/extended study of the PregMet study, ONLY those included in the PregMet study (NCT00159536) can participate.
排除标准
- •Same as in the PregMet study
研究组 & 干预措施
1
Experimental
Metformin 1000mg x 2 daily. Orally. From Weifa
干预措施: Metformin (Drug)
2
Placebo Comparator
Placebo 2 tablets x 2 daily. Orally From Weifa
干预措施: Placebo (Drug)
结局指标
主要结局
Pulsatility index of the uterine artery
时间窗: up to delivery
3 hrs before and after drug intake, 2 weeks after inclusion, and during medication
次要结局
- Blood flow in the umbilical artery and fetal cerebral artery(24 weeks gestational)
研究者
研究点 (1)
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