High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine the efficacy of high dose folic acid supplementation for prevention of preeclampsia in women with at least one risk factor: pre-existing hypertension, pre-pregnancy diabetes (type 1 or 2), twin pregnancy, preeclampsia in a previous pregnancy, or body mass index ≥35. It was hypothesized that high dose (4.0 mg per day) supplementation starting in early pregnancy and continued throughout the entire pregnancy will lower the incidence of preeclampsia in pregnant women at high risk of developing preeclampsia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Folic Acid; Vitamin B Complex

Criteria

Inclusion Criteria:

1. Capability of subject to comprehend and comply with study requirements

2. ≥ 18 years of age at time of consent

3. Subject is taking ≤1.1 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 and 16+6 weeks of pregnancy (Gestational age (GA) of subjects will be calculated based on the first day of the last menstrual period (LMP) or ultrasound performed before 12+6. If early ultrasound and LMP dates differ by ≤ 7 days, base GA estimate on LMP date; if > 7 days, use early < 12+6 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):

• 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)

• Pre-pregnancy diabetes (documented evidence of Type I or type II DM)

• Twin pregnancy

• Documented evidence of history of PE in a previous pregnancy

• BMI > 35 kg/m2 within 3 months prior to this pregnancy and up to randomization of this pregnancy (documented evidence of height and weight to calculate BMI is required)

Exclusion Criteria:

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:

• renal disease with altered renal function,

• epilepsy,

• cancer, or

• 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:

• Alcohol abuse (≥ 2 drinks per day) or alcohol dependence

• 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