Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study

Study answer

What this study found

No final efficacy results are reported in this packet because it describes the trial design rather than completed outcomes. The trial was designed to test whether daily folic acid 4.0 mg could reduce preeclampsia by about 30% (from 12% to 8.4%) in high-risk pregnancies. As of June 15, 2013, 450 participants had been randomized. The authors concluded there was no major safety concern with folic acid supplementation in pregnancy and that testing this regimen was justified.

Study & population

Multicenter randomized placebo-controlled trial in pregnant women at high risk for preeclampsia, conducted in Canada with international collaboration.

Intervention

Oral folic acid 4.0 mg once daily, started at randomization in early pregnancy (8 0/7 to 16 6/7 weeks gestation) and continued until delivery, compared with placebo.

Key limitation

This packet provides a study protocol and recruitment update rather than completed outcome data, so treatment efficacy cannot be assessed.

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Original abstract