Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dehydroepiandrosterone sulfate (DHEAS)
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis polycystic ovary syndrome (PCOS ) before pregnancy
- •BMI 27-40 kg/m2
- •Human chorionic gonadotropin, beta subunit (HCG-beta) verified pregnancy week 5-8
- •At least one of the following criteria: (1) serum testosteron > 2,5 nmol/L; (2) Sex hormone binding globulin (SHBG) < 30 nmol; (3) Fasting C-peptid > 1,0 nmol/L; (4) Menstrual disturbances: oligo-/amenorrhea or metrorrhagia; (5) Hirsutism
排除标准
- •known liver disease or ALAT > 60 IU/L
- •S-creatinin > 130 micromol/L
- •diabetes mellitus
- •alcohol or drug abuse
- •peroral steroid treatment (except inhalation steroids)
- •use of cimetidine, anticoagulant, erythromycin or other macrolides
- •not suitable for other reasons
研究组 & 干预措施
Metformin
Metformin 850 mg x 2 daily
干预措施: Metformin (Drug)
placebo
Placebo 1 tablet x 2 daily
干预措施: Placebo (Drug)
结局指标
主要结局
Dehydroepiandrosterone sulfate (DHEAS)
时间窗: up to delivery
(µmol/l) Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. Measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)
Androstenedione
时间窗: up to delivery
Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. measured by a double antibody technique on an Elecsys 2010 analyser (Roche Diagnostics GmbH, Germany) using reagents and calibrators supplied by the manufacturer
Testosterone
时间窗: up to delivery
Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. measured by a double antibody technique on an Elecsys 2010 analyser (Roche Diagnostics GmbH, Germany) using reagents and calibrators supplied by the manufacturer
Sex hormone binding globulin (SHBG)
时间窗: up to delivery
(nmol/l) Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. Measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)
Free testosterone index
时间窗: up to delivery
Calculated as total testosterone divided by SHBG and multiplied by a factor of 100. SHBG measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)
次要结局
- Occurence of pregnancy complications(up to 6 weeks post partum)
- Pregnancy outcome - gestational age(after delivery)
- Pregnancy outcome - gestational length(after delivery)
- Pregnancy outcome - head circumference(after delivery)
- Pregnancy outcome - birthweight(after delivery)
- Pregnancy outcome - placental weight(after delivery)
- Pregnancy outcome - Agpar score at 5 minutes(after delivery)
- Pregnancy outcome - Agpar score at 10 minutes(after delivery)
- Pregnancy outcome - umbilical artery pH(after delivery)