NL-OMON41628撤回3 期
Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical Trial (FACT) - FACT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Capability of subject to comprehend and comply with study requirements
- •2. * 18 years of age at time of consent
- •3. Subject is taking *1 mg of folic acid daily at the time of randomization
- •4. Live fetus (documented positive fetal heart prior to randomization)
- •5. Gestational age between 8 and 16+6 weeks of pregnancy
- •(Gestational age of subjectswill be calculated based on the first day of the last menstrual period or ultrasound performed before 126/7. If early ultrasound and LMP dates differ by * 7 days, base GA estimate on LMP date; if > 7 days, use early <126/7 ultrasound)
- •6. Subject plans to give birth in a participating hospital site
- •7. Pregnant subjects must fulfill at least one of the following identified risk factors for pre-eclampsia (PE):
- •a) Pre-existing hypertension (documented evidence of diastolic blood pressure *90 mmHg on two separate occasions or at least 4 hours apart prior to randomization, or use of antihypertensive medication during this pregnancy specifically for the treatment of hypertension prior to randomization)
- •b) Pre-pregnancy diabetes (documented evidence of Type I or Type II DM)
- •c) Twin pregnancy
- •d) Documented evidence of history of PE in a previous pregnancy
- •e) BMI > 35 kg/m2 within 3 months prior to this pregnancy or during the first trimester of this pregnancy (documented evidence of height and weight to calculate BMI is required)
排除标准
- •1. Known history or presence of any clinically significant disease or condition which would be a contraindication to folic acid supplementation of up to 5 mg daily for the duration of pregnancy
- •2. Known major fetal anomaly or fetal demise
- •3. History of medical complications, including:
- •a) renal disease with altered renal function,
- •b) epilepsy,
- •c) cancer, or
- •d) use of folic acid antagonists such as valproic acid
- •4. Individual who is currently enrolled or has participated in another clinical trial or who received an investigational drug within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre)
- •5. Known presence of:
- •a) Alcohol abuse (* 2 drinks per day) or alcohol dependence
- •b) Illicit drug/substance use and/or dependence
- •6. Known hypersensitivity to folic acid
- •7. Multiple Pregnancy (triplets or more)
- •8. Participation in this study in a previous pregnancy
研究者
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