Metformin for Prevention of Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome: Randomized Controlled Trial (RCT )
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of participants with gestational diabetes by measuring plasma glucose levels ( mg / dl ).
研究概览
简要总结
Randomized, placebo controlled clinical trial that evaluate the role of taking metformin therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the development of gestational diabetes(GDM) and improving pregnancy outcomes.
详细描述
The study will include a total of 80 pregnant women who fulfill the inclusion and exclusion criteria. Participants will be distributed into two groups :
Group A: Active one (40 women) will receive metformin in a dose of 1500mg per day (500mg every 8hrs in the middle of meal), starting from 12th week of gestation till delivery.
Group B: control group (40 women) will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet.
80 opaque envelope will be numbered serially from 1-80, in each envelope paper containing the group to which the participants will be allocated according to randomization table .The envelopes will be put in one box and when the first patient arrives the first envelope will be open and the patient will be allocated according to the paper inside.
Detection of glucose intolerance will be done using oral glucose tolerance test (OGTT), which based on 75 gm to exclude any case of pre-gestational DM. BMI and blood pressure will be also assessed for all cases at entry of the study.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women had confirmed diagnosis of PCOS before pregnancy according to revised 2003 Rotterdam criteria.
- •Age more than 20 and more than 40 years.
- •BMI ranging from (25_35 )
- •Written and signed informed consent is given from the patient to participate in the study.
排除标准
- •Women with pre-gestational diabetes mellitus confirmed by 2hrs OGTT.
- •Patients who take metformin in the first 12 wk of pregnancy.
- •Patients who are unwilling to participate in the study.
研究组 & 干预措施
Metformin group
40 women will receive metformin in dose of 1500 mg per day orally (500 mg every 8 hrs in the middle of meal) starting from 12th week of gestation till delivery.
干预措施: metformin (Drug)
control group
40 women will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet.
干预措施: placebo (folic acid ) (Drug)
结局指标
主要结局
Number of participants with gestational diabetes by measuring plasma glucose levels ( mg / dl ).
时间窗: 24th -28th week gestation
Diagnosis of GDM when these values are met or exceed fasting plasma glucose level (92 mg/dl).1hr level is (180 mg/dl) and 2hrs level is (153 mg/dl).
次要结局
- Fetal adverse effects(from 12th week gestation till delivery)
- Maternal adverse effects(from 12th week gestation till delivery)
研究者
Ahmed Elsayed Hassan Elbohoty
Assistant professor of Obstetric and Gynecology Faculty of medicine Ain Shams University
Ain Shams University