Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study
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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Open PDFOriginal abstract
Preeclampsia (PE) is hypertension with proteinuria that develops during pregnancy and affects at least 5% of pregnancies. The Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: the Folic Acid Clinical Trial (FACT) aims to recruit 3,656 high risk women to evaluate a new prevention strategy for PE: supplementation of folic acid throughout pregnancy. Pregnant women with increased risk of developing PE presenting to a trial participating center between 80/7 and 166/7 weeks of gestation are randomized in a 1 : 1 ratio to folic acid 4.0 mg or placebo after written consent is obtained. Intent-to-treat population will be analyzed. The FACT study was funded by the Canadian Institutes of Health Research in 2009, and regulatory approval from Health Canada was obtained in 2010. A web-based randomization system and electronic data collection system provide the platform for participating centers to randomize their eligible participants and enter data in real time. To date we have twenty participating Canadian centers, of which eighteen are actively recruiting, and seven participating Australian centers, of which two are actively recruiting. Recruitment in Argentina, UK, Netherlands, Brazil, West Indies, and United States is expected to begin by the second or third quarter of 2013. This trial is registered with NCT01355159.