ISRCTN23781770已完成3 期
Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical Trial
Ottawa Hospital Research Institute (OHRI) (Canada)0 个研究点目标入组 1,198 人开始时间: 2010年3月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,198
研究概览
简要总结
2013 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24349782 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30209050 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33851221/ (added 15/04/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37073421/ results of a secondary analysis (added 26/04/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 28/04/2014:
- •1. Capability of subject to comprehend and comply with study requirements
- •2. At least 18 years of age at time of consent
- •3. Subject is taking less than or equal to 1.1 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 0/7 and 16 6/7 weeks of pregnancy
- •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):
- •7.1 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)
- •7.2 Pre-pregnancy diabetes (documented evidence of Type I or Type II DM)
- •7.3 Twin pregnancy
- •7.4 Documented evidence of history of PE in a previous pregnancy
- •7.5 BMI > 35 kg/m2 within 3 months prior to this pregnancy or up to randomization of this pregnancy (documented evidence of height and weight to calculate BMI is required)
- •Inclusion criteria from 13/03/2012 to 28/04/2014:
- •1. Capability of subject to comprehend and comply with study requirements
- •2. At least 18 years of age at time of consent
- •3. Subject is taking less than or equal to 1.1 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 0/7 and 16 6/7 weeks of pregnancy
- •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):
- •7.1 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)
- •7.2 Pre-pregnancy diabetes (documented evidence of Type I or Type II DM)
- •7.3 Twin pregnancy
- •7.4 Documented evidence of history of PE in a previous pregnancy
- •7.5 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)
- •Inclusion criteria from 14/07/2011 to 13/03/2012:
- •1. Capability of subject to comprehend and comply with study requirements
- •2. At least 18 years of age at time of consent
- •3. Subject is taking less than or equal to 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 0/7 and 16 6/7 weeks of pregnancy
- •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):
- •7.1 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)
- •7.2 Pre-pregnancy diabetes (documented evidence of Type I or Type II DM)
- •7.3 Twin pregnancy
- •7.4 Documented evidence of history of PE in a previous pregnancy
- •7.5 BMI > 35 kg/m2 within 3 months pri
排除标准
- •Current exclusion criteria as of 14/07/2011:
- •1. Known history or presence of any clinically significant disease or condition which would be a contraindication to folic acid supplementation of up to 5.1 mg daily for the duration of pregnancy
- •2. Known major fetal anomaly or fetal demise
- •3. History of medical complications, including:
- •3.1 Renal disease with altered renal function
- •3.2 Epilepsy
- •3.3 Cancer, or
- •3.4 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 history or presence of:
- •5.1 Alcohol abuse (= 2 drinks per day) or alcohol dependence
- •5.2 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
- •Previous exclusion criteria:
- •1. Known history or presence of any clinically significant disease or condition, as determine by the Principal Investigator which he/she believes would be a contraindication to folic acid supplementation of up to 5 mg daily for the pregnancy duration
- •2. Women who have known abnormalities (e.g. hydatidiform mole) or known foetal chromosomal or major malformations in the current pregnancy
- •3. Women who have a history of medical complications, including:
- •3.1. Untreated hypo/hyper thyroidism
- •3.2. Renal disease with altered renal function
- •3.3. Epilepsy
- •3.4. Any collagen disease such as lupus erythromatosus and scleroderma
- •3.5. Active and chronic liver disease (hepatitis)
- •3.6. Cancer
- •3.7. Use of folic acid antagonists such as valproic acid
- •4. Threatened abortion. Women with a previous bleeding in the first trimester, can be included if the site documents a viable foetus at the time of recruitment through ultrasound.
- •5. Women who are using illicit drug or alcohol abuse (greater than or equal to 2 drinks per day) during current pregnancy
- •6. Known history or presence of:
- •6.1. Alcoholism
- •6.2. Drug dependence and/or substance abuse
- •6.3. Hypersensitivity or idiosyncratic reaction to folic acid
- •7. Previously been enrolled in this study
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