NCT00159536已完成3 期
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)
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
- 257
- 试验地点
- 10
- 主要终点
- Preterm delivery
研究概览
简要总结
To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.
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
- •18-45 years,
- •PCOS diagnosis according to Rotterdam criteria
- •single, viable, ultrasound verified fetus
- •if metformin was used at conception and early pregnancy, at least 7 days of "wash out"
排除标准
- •known liver disease or ALAT > 90 nmol/L
- •known renal disease or creatinine > 110 micromol/L
- •diabetes mellitus
- •alcohol or drug abuse
- •peroral steroid treatment
- •cimetidine, anticoagulant or erythromycin treatment at time of inclusion
- •not suitable for other reasons
研究组 & 干预措施
Metformin
Experimental
Metformin 1000mg x 2 daily
干预措施: Metformin (Drug)
placebo
Placebo Comparator
Placebo x 2 daily
干预措施: Placebo (Drug)
结局指标
主要结局
Preterm delivery
时间窗: up to delivery
pre-eclampsia
时间窗: up to delivery
Gestational diabetes
时间窗: up to delivery
incidence of metabolic syndrome and neurophysiologic parameters in offspring
时间窗: Within 18 years
次要结局
- Snoring and sleep quality(up to delivery)
- blood pressure change(up to delivery)
- Incident of instrumental deliveries(at delivery)
- Breastfeeding(One year post partum)
- weight change(up to delivery)
- emesis and hyperemesis(up to delivery)
- Hormone levels in mother and offspring(up to delivery)
研究者
研究点 (10)
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进行中（未招募）
1 期
PregMet 2 studyPoly Cystic Ovarial Syndrome (PCOS) in pregnant women. PCOS should be diagnosed according to the Rotterdam Consensus criterias:- at least 2 out of 3 criterias1.PCO in at least one ovary2.Oligo-/anovulation (clinically diagnosed as oligo-/amenorrhea,i.e. menstrual cycles > 35 days or <10 menstruations/year3.Hyperandrogenismclinical or biochemicalMedDRA version: 14.1Level: LLTClassification code 10065161Term: Polycystic ovarian syndromeSystem Organ Class: 100000004872EUCTR2011-002203-15-SETNU, Norwegian University of Science and Technology1,000