Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study
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 str...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2013-01-01
|
| Series: | Journal of Pregnancy |
| Online Access: | http://dx.doi.org/10.1155/2013/294312 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832550184327839744 |
|---|---|
| author | Shi Wu Wen Josee Champagne Ruth Rennicks White Doug Coyle William Fraser Graeme Smith Dean Fergusson Mark C. Walker |
| author_facet | Shi Wu Wen Josee Champagne Ruth Rennicks White Doug Coyle William Fraser Graeme Smith Dean Fergusson Mark C. Walker |
| author_sort | Shi Wu Wen |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-03c2f12faedb48aca93ddaed30f080c2 |
| institution | Kabale University |
| issn | 2090-2727 2090-2735 |
| language | English |
| publishDate | 2013-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Pregnancy |
| spelling | doaj-art-03c2f12faedb48aca93ddaed30f080c22025-02-03T06:07:29ZengWileyJournal of Pregnancy2090-27272090-27352013-01-01201310.1155/2013/294312294312Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial StudyShi Wu Wen0Josee Champagne1Ruth Rennicks White2Doug Coyle3William Fraser4Graeme Smith5Dean Fergusson6Mark C. Walker7OMNI Research Group, Department of Obstetrics and Gynecology, Faculty of Medicine, Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8L6, CanadaOMNI Research Group, Department of Obstetrics and Gynecology, Faculty of Medicine, Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8L6, CanadaOMNI Research Group, Department of Obstetrics and Gynecology, Faculty of Medicine, Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8L6, CanadaDepartment of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON, CanadaDepartment of Obstetrics and Gynecology, Ste. Justine Hospital, 3175 Cote Ste. Catherine, Montreal, QC, H3T 1C5, CanadaQueen’s Perinatal Research Unit, Department of Obstetrics and Gynecology, Queen’s University, 76 Stuart Street, Connell 4, Kingston, ON, K7L 2V7, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, K1H 8L6, CanadaOMNI Research Group, Department of Obstetrics and Gynecology, Faculty of Medicine, Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8L6, CanadaPreeclampsia (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.http://dx.doi.org/10.1155/2013/294312 |
| spellingShingle | Shi Wu Wen Josee Champagne Ruth Rennicks White Doug Coyle William Fraser Graeme Smith Dean Fergusson Mark C. Walker Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study Journal of Pregnancy |
| title | Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study |
| title_full | Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study |
| title_fullStr | Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study |
| title_full_unstemmed | Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study |
| title_short | Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study |
| title_sort | effect of folic acid supplementation in pregnancy on preeclampsia the folic acid clinical trial study |
| url | http://dx.doi.org/10.1155/2013/294312 |
| work_keys_str_mv | AT shiwuwen effectoffolicacidsupplementationinpregnancyonpreeclampsiathefolicacidclinicaltrialstudy AT joseechampagne effectoffolicacidsupplementationinpregnancyonpreeclampsiathefolicacidclinicaltrialstudy AT ruthrennickswhite effectoffolicacidsupplementationinpregnancyonpreeclampsiathefolicacidclinicaltrialstudy AT dougcoyle effectoffolicacidsupplementationinpregnancyonpreeclampsiathefolicacidclinicaltrialstudy AT williamfraser effectoffolicacidsupplementationinpregnancyonpreeclampsiathefolicacidclinicaltrialstudy AT graemesmith effectoffolicacidsupplementationinpregnancyonpreeclampsiathefolicacidclinicaltrialstudy AT deanfergusson effectoffolicacidsupplementationinpregnancyonpreeclampsiathefolicacidclinicaltrialstudy AT markcwalker effectoffolicacidsupplementationinpregnancyonpreeclampsiathefolicacidclinicaltrialstudy |