A Prospective, Randomized, Double-blind, Multi-centre Study, Where the Possible Effect of Metformin to Prevent Late Miscarriage and Preterm Delivery is Studied in Women With Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 489
- 试验地点
- 13
- 主要终点
- combined incidence of late miscarriages and preterm births
研究概览
简要总结
The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting.
The investigators hypothesis is that metformin compared to placebo treatment from the first trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and preterm birth (gestational week < 37) in PCOS women diagnosed according to Rotterdam 2003 consensus criteria, with singleton pregnancy.
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
- •Age: 18-45 years
- •PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5 years prior to inclusion
- •Mode of conception: Any
- •Single, viable fetus, diagnosed by vaginal ultrasound
- •Gestational week at inclusion: week 6 + 0 to 12 + 0
- •Wash out for metformin: at least 7 days
- •Able to communicate fluently in the official language at the study cite or English
排除标准
- •Any type of diabetes (except GDM in former pregnancy)
- •Known liver disease or ALAT > 100 IU/L
- •Known kidney disease or creatinine > 110 μmol/L
- •Known alcohol or drug abuse
- •Use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidine, anticoagulation therapy
- •Unsuitable for participation of other reasons
研究组 & 干预措施
metformin
干预措施: Metformin (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
combined incidence of late miscarriages and preterm births
时间窗: at delivery
This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications.
次要结局
- NICU admissions and total number of days in NICU/baby(2 months)
- Prevalence of preeclampsia(up to delivery)
- number of patients hospitalized(at delivery)
- Prevalence of gestational diabetes(up to delivery)
- Total number of hospitalization days/ hospitalized participant(2 months)
- SNP(at delivery)