High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention

PHASE3CompletedINTERVENTIONAL
Enrollment

2,464

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

July 31, 2016

Study Completion Date

September 30, 2016

Conditions
Pregnancy ComplicationsPreeclampsia
Interventions
DRUG

Folic Acid 4 mg

Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid

DRUG

Placebo

Placebo x 4 tablets will be taken daily by oral administration.

Trial Locations (72)

2750

Nepean, Penrith

3021

Sunshine, St Albans

3052

Royal Women's Hospital, Parkville

4305

Ipswich, Ipswich

4814

Townsville, Douglas

5006

Adelaide, North Adelaide

S2000DKR

Hospital Escuela Eva Perón, Rosario

Unknown

Hospital Provincial, Rosario

Hospital Roque Saenz Penia, Rosario

Maternidad Martin, Rosario

Sanatorio de la Mujer, Rosario

Cemic, Buenos Aires

Hospital Cullen, Santa Fe

Hosptial Iturraspe, Santa Fe

Jubilee, Kingston

Spanishtown, Kingston

University of West Indies, Kingston

T2N2T9

Calgary Foothills Medical Center, Calgary

T5H 3V9

Edmonton Lois Hole Hospital for Women, Edmonton

V5Z 4H4

Vancouver BC Women's Hospital and Health Center, Vancouver

V6Z 2K5

St-Paul's Hospital, Vancouver

E3B 5N5

Fredericton Dr. Everett Chalmers Regional Hospital, Fredericton

E1C 6Z8

Moncton Hospital, Moncton

E2L 4L2

Saint John Regional Hospital, Saint John

R2H 2A6

Winnipeg St. Boniface General Hospital, Winnipeg

R3E 3P4

Winnipeg University of Manitoba, Winnipeg

A1B 3V6

St-John's Women's Health Centre, St. John's

L8S 4K1

Hamilton McMaster University, Hamilton

K7L 2V7

Kingston, Kingston

N6A 5W9

London, London

K1H 8L6

Ottawa Hospital, Ottawa

K1Y 4E9

Civic Hospital, Ottawa

P6B 0A8

Sault Ste- Marie Sault Area Hospital, Sault Ste. Marie

M4N 3M5

Sunnybrook Health Sciences, Toronto

G1V 4G2

Quebec City (CHUL) Centre Hospitalier Universitaire, Montreal

H2X 3J4

Saint-Luc CHUM - Montreal, Montreal

H3A 1A1

McGill University Royal Victoria Hospital, Montreal

H3T 1C5

Sainte-Justine, Montreal

H3T 1M5

St-Mary's Hospital, Montreal

S4P 0W5

Regina Qu'Appelle Health Region, Regina

PE29 6NT

Hinchingbrooke, Huntingdon

WA51QC

Warrington and Halton Hospitals NHS Foundation Trust, Warrington

DL3 6HX

Darlington Memorial Hospital, Darlington

DH1 5TW

University Hospital of North Durham, Durham

CA27HY

Cumberland Infirmary, Carlisle

CA288JG

West Cumberland Hospital, Whitehaven

BL9 7TD

Fairfield, Bury

OL12 0NB

Rochdale, Rochdale

LN2 4AX

Lincolnshire, Lincoln

PR8 6PN

Ormskirk, Southport

HA1 3UJ

Northwick Park Hospital, Harrow

TW7 6AF

West Middlesex University Hospital, Isleworth

NE13 9BA

49 Marine Avenue & CCGs, Whitley Bay

NE63 9JJ

Wansbeck General Hospital, Ashington

SW17 0QT

St George's Hospital, London

NE9 6SX

Gateshead Queen Elizabeth Hospital, Gateshead

NE34 0PL

South Tyneside District Hospital, South Shields

WV100QP

The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton

BB2 3HH

Blackburn, Blackburn

BB10 2PQ

Burnley, Burnley

M8 5RB

North Manchester, Crumpsall

SE1 9RT

Guy's & St Thomas' Hospital, London

TS4 3BW

South Tees Hospital, Middlesbrough

NE1 4LP

Newcastle upon Tyne Hospitals, Newcastle upon Tyne

NE29 8NH

North Tyneside General Hospital, North Shields

NR4 7UY

Norfolk & Norwich, Norwich

NG5 1PB

Nottingham City Hospital, Nottingham

NG7 2UH

Nottingham Queens Medical Centre, Nottingham

OL1 2JH

Oldham, Oldham

TS19 9AH

North Tees Hospital, Stockton

SR4 7TP

Sunderland Royal Hospital, Sunderland

UB8 3NN

Hillingdon Hospital, Uxbridge

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

Ottawa Hospital Research Institute

OTHER