Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical Trial (FACT)
- Conditions
- preeclampsia10026908toxemia
- Registration Number
- NL-OMON41628
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 300
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method