Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical Trial (FACT)A randomized, double-blind, placebo-controlled, Phase III, international multi-centre study of 4.0 mg of Folic Acid supplementation in pregnancy for the prevention of preeclampsia - Folic Acid Clinical Trial (FACT)

Ottawa Hospital Research Institute0 个研究点目标入组 3,656 人开始时间: 2020年7月30日最近更新: 2020年8月3日

适应症

试验速览

暂无简介。

•The patient has the mental capacity to understand the trial procedures and to be recruited into the the trial.
•18 years or older at the time of consent
•Patient is taking less than or equal to 1.1 mg of folic acid daily at the time of randomisation.
•Live fetus(documented positive fetal heart beat) prior to randomisation
•Gestational Age between 8 0/7 and 16 6/7 at time of randomisation.
•Subject plans to give birth in the participating hospital site.
•Patient must fulfil at least one of the following risk factors for Preeclampsia;
•Pre-existing hypertension
•Pre-pregnancy diabetes
•Twin pregnancy
•Documented evidence of history of PE in a previous pregnancy
•BMI = 35 kg/m2 within 3 months prior to this pregnancy or during 1st trimester.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 750
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Indication for high dose folic acid (5 mg) during pregnancy e.g. to reduce risk of fetal central nervous system anomaly (e.g. neural tube defect) based on family or personal history.
•Known history or presence of any clinically significant disease or condition which would be a contraindicaiton to folic acid supplemenation of up to 5.1 mg daily for the duration of the pregnancy.
•Known major fetal anomaly or fetal demise
•History of medical complications, including: -
•a) renal disease with altered renal function
•b) epilepsy
•d) user of folic acid antagonists such as valproic acid
•Patient who is taking part in another clinical trial, or has participated in another clinical trial, or received investigational drug within 3 months of the date of randomisation (unless approved by the Trial Coordinating Centre)
•Known presence of alcohol abuse or alcohol dependance.
•Drug substance use and/or dependance.
•Known hypersensitivity to folic acid.
•Multiple Pregnancy (triplets or more)
•Participation in this study in a previous pregnancy.

发起方