ACTRN12622001577707尚未招募未知
The effectiveness of 5-methyltetrahydrofolate versus folic acid prenatal multivitamins in couples with a history of recurrent pregnancy loss: A randomised-controlled feasibility trial
niversity of Technology Sydney0 个研究点目标入组 120 人开始时间: 2022年12月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 49 Years（—）
- 性别
- All
入选标准
- •1. Women aged 20-49 years of age with two or more pregnancy losses before 22 weeks and their reproductive partners
- •2. Ability to speak and understand English sufficiently to comprehend the purpose and risks of the study and to provide consent
- •3. Ability to attend a pathology centre for specimen collection
- •4. Ability to not take concomitant medications, vitamins, food containing folic acid
排除标准
- •1. Pregnant or lactating women
- •2. Couples who are currently undergoing assisted reproductive technologies
- •3. Men and women taking folate antagonist medication (phenytoin, valproic acid, valproate sodium, carbamazepine, methotrexate, trimethoprim hydrochloride, trimethoprim sulphate, trimethoprim, aminopterin sodium, phenobarbital, phenobarbital sodium, primidone, divalproex)
- •4. Individuals with a known sensitivity to any ingredients in the products
- •5. History or presence of psychiatric disorders (including depression and severe anxiety), autoimmune disease, and cancer
- •6. History of gynaecological and/or genetic problems– antiphospholipid syndrome, blocked fallopian tubes, Pelvic inflammatory disease, Primary ovarian insufficiency, endometriosis, Uterine fibroids, Factor V Leiden
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