Phase 4 Study of Effectiveness of Metformin in Patients With Unexplained Recurrent Miscarriages
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The primary outcome is to evaluate the clinical pregnancy rate and the effectiveness of Metformin in the reduction of EPL in women with PCOS
研究概览
简要总结
The prevalence of insulin resistance is increased in women with recurrent miscarriage compared with matched fertile controls,Insulin resistance (IR) in this syndrome is not only implicated toward early pregnancy loss (EPL) but also pathognomic for various obstetrical complications during pregnancy.An elevated free androgen index appears to be a prognostic factor for a subsequent miscarriage in women with recurrent miscarriage.
There is insufficient evidence to evaluate the effect of metformin supplementation in pregnancy to prevent a miscarriage in women with recurrent miscarriage.
详细描述
The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive. Pregnancy follow up including the early and second trimester pregnancy loss, Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women who are diagnosed to have PCOS and/or haven hyper insulinaemia and have a previous history of recurrent miscarriages.
排除标准
- •Any patients with PCOS or hyper insulinaemia previously treated by any forms of insulin sensitizers.
- •Age above forty years old .
- •Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
- •Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
- •Fibroids distorting uterine cavity .
- •Abnormal parental karyotype .
- •Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
研究组 & 干预措施
Metformin
The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive
干预措施: Metformin (Drug)
结局指标
主要结局
The primary outcome is to evaluate the clinical pregnancy rate and the effectiveness of Metformin in the reduction of EPL in women with PCOS
时间窗: 2 ys
The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy,
次要结局
- Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study and any fetal malformation(2 ys)
研究者
alaa eldeen mahmoud ismail
M D
Woman's Health University Hospital, Egypt