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BMJ. 2018 Sep 12;362:k3478. doi: 10.1136/bmj.k3478.

Effect of high dose folic acid supplementation in pregnancy on pre-eclampsia (FACT): double blind, phase III, randomised controlled, international, multicentre trial.

Author information

1
OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
2
School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada.
3
Department of Obstetrics, Gynecology & Newborn Care, University of Ottawa, Ottawa, Ontario, Canada.
4
Institute of Cellular Medicine, The Medical School, Newcastle University, Newcastle upon Tyne, UK.
5
Obstetric Medicine, Robinson Research Institute, University of Adelaide, South Australia, Australia.
6
Women's and Children's Hospital, Adelaide, South Australia, Australia.
7
Department of Obstetrics and Gynaecology, Faculty of Medical Sciences, The University of the West Indies, Mona, Kingston, Jamaica.
8
Centro Rosarino de Estudios Perinatales (CREP), Rosario, Santa Fé, Argentina.
9
Queen's Perinatal Research Unit, Kingston General Hospital, Department of Obstetrics and Gynecology, Queens University, Kingston, Ontario, Canada.
10
Mother & Child Axis, Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.
11
Centre de Recherche, Universite de Sherbrooke, Sherbrooke, Quebec, Canada.
12
Department of Obstetrics and Gynecology, Faculty of Medicine and Health Sciences, Centre de recherche du CHUS, University of Sherbrooke, Sherbrooke, Quebec, Canada.
13
Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
14
Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
15
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
16
Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.
17
Department of Obstetrics and Gynecology, University of Alberta, Edmonton, Alberta, Canada.
18
Department of Physiology, University of Alberta, Edmonton, Alberta, Canada.
19
Maternal-Fetal Medicine Division, Department of Obstetrics and Gynecology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.
20
Departments of Medicine, School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada.
21
Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.
22
Department of Obstetrics, University Medical Center, Utrecht, Utrecht, Netherlands.
23
Department of Obstetrics, Academic Medical Center, Amsterdam, Netherlands.
24
OMNI Research Group, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada mwalker@ohri.ca.

Abstract

OBJECTIVE:

To determine the efficacy of high dose folic acid supplementation for prevention of pre-eclampsia in women with at least one risk factor: pre-existing hypertension, prepregnancy diabetes (type 1 or 2), twin pregnancy, pre-eclampsia in a previous pregnancy, or body mass index ≥35.

DESIGN:

Randomised, phase III, double blinded international, multicentre clinical trial.

SETTING:

70 obstetrical centres in five countries (Argentina, Australia, Canada, Jamaica, and UK).

PARTICIPANTS:

2464 pregnant women with at least one high risk factor for pre-eclampsia were randomised between 2011 and 2015 (1144 to the folic acid group and 1157 to the placebo group); 2301 were included in the intention to treat analyses.

INTERVENTION:

Eligible women were randomised to receive either daily high dose folic acid (four 1.0 mg oral tablets) or placebo from eight weeks of gestation to the end of week 16 of gestation until delivery. Clinicians, participants, adjudicators, and study staff were masked to study treatment allocation.

MAIN OUTCOME MEASURE:

The primary outcome was pre-eclampsia, defined as hypertension presenting after 20 weeks' gestation with major proteinuria or HELLP syndrome (haemolysis, elevated liver enzymes, low platelets).

RESULTS:

Pre-eclampsia occurred in 169/1144 (14.8%) women in the folic acid group and 156/1157 (13.5%) in the placebo group (relative risk 1.10, 95% confidence interval 0.90 to 1.34; P=0.37). There was no evidence of differences between the groups for any other adverse maternal or neonatal outcomes.

CONCLUSION:

Supplementation with 4.0 mg/day folic acid beyond the first trimester does not prevent pre-eclampsia in women at high risk for this condition.

TRIAL REGISTRATION:

Current Controlled Trials ISRCTN23781770 and ClinicalTrials.gov NCT01355159.

PMID:
30209050
PMCID:
PMC6133042
DOI:
10.1136/bmj.k3478
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisations for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

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