- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355159
High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention (FACT)
Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia-Folic Acid Clinical Trial (FACT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preeclampsia is a complication of pregnancy which affects at least 5% of all pregnancies worldwide and has serious health consequences to these women and their babies. Preeclampsia is hypertension (high blood pressure) in pregnancy with proteinuria. Proteinuria is when protein is found in the urine, and it is a sign that the kidneys are not functioning properly. The only effective treatment for preeclampsia is delivery of the baby. Because delivery may be required before the anticipated date of delivery; preeclampsia is also one of the leading causes of preterm delivery and accounts for 25% of very low birth weight infants. Recent research has also shown that women who have had preeclampsia during pregnancy are more likely to be at risk for future cardiovascular events later in life.
Recently some studies have shown that supplementation with multivitamins containing folic acid is associated with a reduced risk of developing preeclampsia. These findings also suggested that for the prevention of preeclampsia, a high dose of folic acid (much higher than the amount of folate received from food intake or what is usually taken during pregnancy) may be needed.
A randomized controlled trial was conducted in 70 obstetrical centres in 5 countries (Argentina, Australia, Canada, Jamaica, and the UK) to evaluate the effect of high dose folic acid started in early pregnancy on the risk of developing preeclampsia in high-risk women. A sample size of 2464 allowed for 80% power and a 10% loss to follow-up/study withdrawal. Participants received either placebo or four 1.0 mg oral tablets of folic acid.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina
- Cemic
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Santa Fe, Argentina
- Hospital Cullen
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Santa Fe, Argentina
- Hosptial Iturraspe
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DKR
- Hospital Escuela Eva Perón
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Rosario, Santa Fe, Argentina
- Hospital Provincial
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Rosario, Santa Fe, Argentina
- Hospital Roque Saenz Penia
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Rosario, Santa Fe, Argentina
- Maternidad Martin
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Rosario, Santa Fe, Argentina
- Sanatorio de la Mujer
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New South Wales
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Penrith, New South Wales, Australia, 2750
- Nepean
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Queensland
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Douglas, Queensland, Australia, 4814
- Townsville
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Ipswich, Queensland, Australia, 4305
- Ipswich
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South Australia
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North Adelaide, South Australia, Australia, 5006
- Adelaide
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Women's Hospital
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St Albans, Victoria, Australia, 3021
- Sunshine
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Alberta
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Calgary, Alberta, Canada, T2N2T9
- Calgary Foothills Medical Center
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Edmonton, Alberta, Canada, T5H 3V9
- Edmonton Lois Hole Hospital for Women
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2K5
- St-Paul's Hospital
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Vancouver, British Columbia, Canada, V5Z 4H4
- Vancouver BC Women's Hospital and Health Center
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New Brunswick
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Fredericton, New Brunswick, Canada, E3B 5N5
- Fredericton Dr. Everett Chalmers Regional Hospital
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Moncton, New Brunswick, Canada, E1C 6Z8
- Moncton Hospital
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Winnipeg, New Brunswick, Canada, R2H 2A6
- Winnipeg St. Boniface General Hospital
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Winnipeg, New Brunswick, Canada, R3E 3P4
- Winnipeg University of Manitoba
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Canada, A1B 3V6
- St-John's Women's Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Hamilton McMaster University
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Kingston, Ontario, Canada, K7L 2V7
- Kingston
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London, Ontario, Canada, N6A 5W9
- London
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital
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Ottawa, Ontario, Canada, K1Y 4E9
- Civic Hospital
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Sault Ste. Marie, Ontario, Canada, P6B 0A8
- Sault Ste- Marie Sault Area Hospital
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Toronto, Ontario, Canada, M4N 3M5
- SunnyBrook Health Sciences
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Quebec
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Montreal, Quebec, Canada, G1V 4G2
- Quebec City (CHUL) Centre Hospitalier Universitaire
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Montreal, Quebec, Canada, H3T 1C5
- Sainte-Justine
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Montreal, Quebec, Canada, H3T 1M5
- St-Mary's Hospital
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Montreal, Quebec, Canada, H2X 3J4
- Saint-Luc CHUM - Montreal
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Montreal, Quebec, Canada, H3A 1A1
- McGill University Royal Victoria Hospital
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Saskatchewan
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Regina, Saskatchewan, Canada, S4P 0W5
- Regina Qu'Appelle Health Region
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Kingston, Jamaica
- Jubilee
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Kingston, Jamaica
- Spanishtown
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Kingston 7, Jamaica
- University of West Indies
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Blackburn, United Kingdom, BB2 3HH
- Blackburn
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Burnley, United Kingdom, BB10 2PQ
- Burnley
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Crumpsall, United Kingdom, M8 5RB
- North Manchester
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London, United Kingdom, SE1 9RT
- Guy's & St Thomas' Hospital
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Middlesbrough, United Kingdom, TS4 3BW
- South Tees Hospital
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Newcastle upon Tyne, United Kingdom, NE1 4LP
- Newcastle upon Tyne Hospitals
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North Shields, United Kingdom, NE29 8NH
- North Tyneside General Hospital
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Norwich, United Kingdom, NR4 7UY
- Norfolk & Norwich
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Nottingham, United Kingdom, NG5 1PB
- Nottingham City Hospital
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Nottingham, United Kingdom, NG7 2UH
- Nottingham Queens Medical Centre
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Oldham, United Kingdom, OL1 2JH
- Oldham
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Stockton, United Kingdom, TS19 9AH
- North Tees Hospital
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Sunderland, United Kingdom, SR4 7TP
- Sunderland Royal Hospital
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Uxbridge, United Kingdom, UB8 3NN
- Hillingdon Hospital
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Cambridgeshire
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Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
- Hinchingbrooke
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Cheshire
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Warrington, Cheshire, United Kingdom, WA51QC
- Warrington and Halton Hospitals NHS Foundation Trust
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County Durham
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Darlington, County Durham, United Kingdom, DL3 6HX
- Darlington Memorial Hospital
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Durham, County Durham, United Kingdom, DH1 5TW
- University Hospital of North Durham
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Cumbria
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Carlisle, Cumbria, United Kingdom, CA27HY
- Cumberland Infirmary
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Whitehaven, Cumbria, United Kingdom, CA288JG
- West Cumberland Hospital
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Lancashire
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Bury, Lancashire, United Kingdom, BL9 7TD
- Fairfield
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Rochdale, Lancashire, United Kingdom, OL12 0NB
- Rochdale
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Lincolnshire
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Lincoln, Lincolnshire, United Kingdom, LN2 4AX
- Lincolnshire
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Merseyside
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Southport, Merseyside, United Kingdom, PR8 6PN
- Ormskirk
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Middlesex
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Harrow, Middlesex, United Kingdom, HA1 3UJ
- Northwick Park Hospital
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Isleworth, Middlesex, United Kingdom, TW7 6AF
- West Middlesex University Hospital
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Newcastle Upon Tyne
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Whitley Bay, Newcastle Upon Tyne, United Kingdom, NE13 9BA
- 49 Marine Avenue & CCGs
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Northumberland
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Ashington, Northumberland, United Kingdom, NE63 9JJ
- Wansbeck General Hospital
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Tooting
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London, Tooting, United Kingdom, SW17 0QT
- St George's Hospital
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Tyne And Wear
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Gateshead, Tyne And Wear, United Kingdom, NE9 6SX
- Gateshead Queen Elizabeth Hospital
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South Shields, Tyne And Wear, United Kingdom, NE34 0PL
- South Tyneside District Hospital
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West Midlands
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Wolverhampton, West Midlands, United Kingdom, WV100QP
- The Royal Wolverhampton NHS Trust, New Cross Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Capability of subject to comprehend and comply with study requirements
- ≥ 18 years of age at time of consent
- Subject is taking ≤1.1 mg of folic acid daily at the time of randomization
- Live fetus (documented positive fetal heart prior to randomization)
- Gestational age between 8+0 and 16+6 weeks of pregnancy (Gestational age (GA) of subjects will be calculated based on the first day of the last menstrual period (LMP) or ultrasound performed before 12+6. If early ultrasound and LMP dates differ by ≤ 7 days, base GA estimate on LMP date; if > 7 days, use early < 12+6 ultrasound)
- Subject plans to give birth in a participating hospital site
Pregnant subjects must fulfill at least one of the following identified risk factors for pre-eclampsia (PE):
- Pre-existing hypertension (documented evidence of diastolic blood pressure ≥ 90 mmHg on two separate occasions or at least 4 hours apart prior to randomization, or use of antihypertensive medication during this pregnancy specifically for the treatment of hypertension prior to randomization)
- Pre-pregnancy diabetes (documented evidence of Type I or type II DM)
- Twin pregnancy
- Documented evidence of history of PE in a previous pregnancy
- BMI > 35 kg/m2 within 3 months prior to this pregnancy and up to randomization of this pregnancy (documented evidence of height and weight to calculate BMI is required)
Exclusion Criteria:
- Known history or presence of any clinically significant disease or condition which would be a contraindication to folic acid supplementation of up to 5 mg daily for the duration of pregnancy
- Known major fetal anomaly or fetal demise
History of medical complications, including:
- renal disease with altered renal function,
- epilepsy,
- cancer, or
- use of folic acid antagonists such as valproic acid
- Individual who is currently enrolled or has participated in another clinical trial or who received an investigational drug within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre)
Known presence of:
- Alcohol abuse (≥ 2 drinks per day) or alcohol dependence
- Illicit drug/substance use and/or dependence
- Known hypersensitivity to folic acid
- Multiple Pregnancy (triplets or more)
- Participation in this study in a previous pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Folic Acid 4 mg
Folic Acid 1.0 mg 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
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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
Other Names:
|
Placebo Comparator: Placebo
Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo
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Placebo x 4 tablets will be taken daily by oral administration.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preeclampsia
Time Frame: Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery)
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PE is defined as diastolic blood pressure ≥90 mmHg on two occasions ≥4 hours apart and proteinuria developed in women greater than 20+0 weeks of gestation. Proteinuria is defined as: urinary protein ≥300mg in 24 hour urine collection OR in the absence of 24 hour collection, ≥2+ dipstick proteinuria, OR random protein-creatinine ratio ≥30mg protein/mmol. OR HELLP (Haemolysis, Elevated, Liver Enzymes, Low Platelets) syndrome defined as: Haemolysis (characteristic peripheral blood smear), Serum LDH ≥ 600U/L, Serum AST ≥ 70U/L, and Platelet count <100 x109/L OR Superimposed pre-eclampsia, defined as history of pre-existing hypertension (diagnosed pre-pregnancy or before 20+0 weeks' gestation) with new proteinuria. |
Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Death
Time Frame: Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery)
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According to the World Health Organization, "A maternal death is defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.
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Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery)
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Spontaneous Abortion
Time Frame: Participants will be followed from randomization until 20+0 weeks of gestation
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Spontaneous abortion or miscarriage defined as death of a fetus <500g or <20 weeks of gestation
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Participants will be followed from randomization until 20+0 weeks of gestation
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Placenta Abruption
Time Frame: Participants will be followed from 20+0 weeks of gestation until delivery
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Placental abruption (abruptio placentae) is the premature detachment of a normally positioned placenta from the wall of the uterus.
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Participants will be followed from 20+0 weeks of gestation until delivery
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Premature Rupture of Membranes
Time Frame: Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor
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Rupture of the membranes (rupture of the amniotic sac) before the onset of labor.
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Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor
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Preterm Birth
Time Frame: Participants will be followed from 20+0 weeks to 36+6 weeks of gestation
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Birth that occur earlier than 37+0 weeks of gestational age.
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Participants will be followed from 20+0 weeks to 36+6 weeks of gestation
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HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count)
Time Frame: Participants will be followed from 20+0 weeks of gestation until delivery
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Haemolysis (characteristic peripheral blood smear), Serum LDH >=600U/L, Serum AST >=70U/L, Platelet count <100 x109/L
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Participants will be followed from 20+0 weeks of gestation until delivery
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Severe Preeclampsia
Time Frame: Participants will be followed from 20+0 weeks of gestation until delivery.
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Severe PE: Defined as PE with convulsion or HELLP or delivery <34 weeks.
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Participants will be followed from 20+0 weeks of gestation until delivery.
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Antenatal Inpatient Length of Stay
Time Frame: Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery
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Length of inpatient stay before admission for delivery in days
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Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery
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Stillbirth
Time Frame: Participants will be followed from 20+0 weeks of gestation up to delivery.
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Fetal death defined as death of fetus of at least 500 grams birth weight or, if birth weight is unavailable, a gestational age of at least 20+0 weeks of gestation.
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Participants will be followed from 20+0 weeks of gestation up to delivery.
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Intrauterine Growth Restriction (<3rd Percentile)
Time Frame: Participants will be followed from 20+0 weeks of gestation until delivery
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Intrauterine growth restriction is defined as a birth weight less than the 3rd percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard.
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Participants will be followed from 20+0 weeks of gestation until delivery
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Intrauterine Growth Restriction (<10th Percentile)
Time Frame: Participants will be followed from 20+0 weeks of gestation until delivery
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Intrauterine growth restriction is defined as a birth weight less than the 10th percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard.
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Participants will be followed from 20+0 weeks of gestation until delivery
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Neonatal Death
Time Frame: Participants will be followed from birth until 28 days of life
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Neonatal death defined as death of a baby that occurred during first 28 days of life.
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Participants will be followed from birth until 28 days of life
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Perinatal Mortality
Time Frame: Participants will be followed from 20+0 weeks of gestation until 28 days of life.
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The perinatal mortality is defined as the number of deaths (fetal deaths and neonatal deaths) of babies ≥ 500 grams birth weight or, if birth weight is unavailable, a gestational age ≥ 20+0 weeks, up to 28 completed days after birth.
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Participants will be followed from 20+0 weeks of gestation until 28 days of life.
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Retinopathy of Prematurity
Time Frame: Infants born to the participant will be followed for the duration of hospital stay, or up to 6 weeks
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Retinopathy of prematurity a retinopathy typically occurring in premature infants treated with high concentrations of oxygen, characterized by vascular dilatation, proliferation, tortuosity, edema, retinal detachment, and fibrous tissue behind the lens confirmed by retinal examination according to an International Committee for the Classification of Retinopathy of Prematurity.
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Infants born to the participant will be followed for the duration of hospital stay, or up to 6 weeks
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Early Onset Sepsis
Time Frame: Infants born to the participants will be followed first 48 hours of life.
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Within first 48hr of life, confirmed by positive blood or cerebrospinal fluid cultures
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Infants born to the participants will be followed first 48 hours of life.
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Necrotising Enterocolitis
Time Frame: Infants borm to the participants will be followed for the duration of hospital stay, or up to 6 weeks.
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Necrotizing enterocolitis (NEC) according to modified Bell's criteria stage 2 or higher (grossly bloody stool, plus absent bowel sounds with or without abdominal tenderness and radiographic findings such as intestinal dilation, ileus, pneumatosis intestinalis), excluding isolated spontaneous intestinal perforations.
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Infants borm to the participants will be followed for the duration of hospital stay, or up to 6 weeks.
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Intraventricular Hemorrhage (IVH)
Time Frame: Time Frame: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks
|
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Time Frame: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks
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Ventilation
Time Frame: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks.
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Ventilatory support after initial resuscitation, with/without intubation.
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Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks.
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Need for Oxygen at 28 Days
Time Frame: Infants to the participants will be followed for 28 days after birth.
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Infants to the participants will be followed for 28 days after birth.
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Composite Severe Adverse Fetal/Neonatal Outcome
Time Frame: Outcomes included in the composite outcome were measured for each of their respective time frames, up to 6-weeks after birth
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Composite outcome included any of retinopathy of prematurity, periventricular leukomacia, early onset sepsis, necrotizing enterocolitis, intraventricular haemorrhage, ventilation.
Need for O2at 28 days, NICU admission
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Outcomes included in the composite outcome were measured for each of their respective time frames, up to 6-weeks after birth
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Length of Stay in 'High Level' Neonatal Care Unit
Time Frame: Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.
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Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.
|
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Neonatal Death
Time Frame: Infants to the participants will be followed for 28 days after birth.
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Neonatal death defined as death of the infant occurred before 28 days of life
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Infants to the participants will be followed for 28 days after birth.
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Periventricular Leukomalacia
Time Frame: Infants to the participants were followed for 28 days after birth.
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One of the two outcomes used to measure neonatal morbidity.
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Infants to the participants were followed for 28 days after birth.
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Neonatal Intensive Care Unit (NICU) Admission
Time Frame: Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.
|
This outcome measured whether or not the infant was admitted into the NICU.
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Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shi Wu Wen, PhD, Ottawa Hospital Research Institute
- Principal Investigator: Mark C Walker, MD, Ottawa Hospital Research Institute
Publications and helpful links
General Publications
- Rose EG, Murphy MSQ, Erwin E, Muldoon KA, Harvey ALJ, Rennicks White R, MacFarlane AJ, Wen SW, Walker MC. Gestational Folate and Folic Acid Intake among Women in Canada at Higher Risk of Pre-Eclampsia. J Nutr. 2021 Jul 1;151(7):1976-1982. doi: 10.1093/jn/nxab063.
- Corsi DJ, Gaudet LM, El-Chaar D, White RR, Rybak N, Harvey A, Muldoon K, Wen SW, Walker M. Effect of high-dose folic acid supplementation on the prevention of preeclampsia in twin pregnancy. J Matern Fetal Neonatal Med. 2022 Feb;35(3):503-508. doi: 10.1080/14767058.2020.1725882. Epub 2020 Feb 18.
- Wen SW, White RR, Rybak N, Gaudet LM, Robson S, Hague W, Simms-Stewart D, Carroli G, Smith G, Fraser WD, Wells G, Davidge ST, Kingdom J, Coyle D, Fergusson D, Corsi DJ, Champagne J, Sabri E, Ramsay T, Mol BWJ, Oudijk MA, Walker MC; FACT Collaborating Group. Effect of high dose folic acid supplementation in pregnancy on pre-eclampsia (FACT): double blind, phase III, randomised controlled, international, multicentre trial. BMJ. 2018 Sep 12;362:k3478. doi: 10.1136/bmj.k3478.
- Wen SW, Champagne J, Rennicks White R, Coyle D, Fraser W, Smith G, Fergusson D, Walker MC. Effect of folic acid supplementation in pregnancy on preeclampsia: the folic acid clinical trial study. J Pregnancy. 2013;2013:294312. doi: 10.1155/2013/294312. Epub 2013 Nov 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-107
- ISRCTN23781770 (Other Identifier: controlled-trials.com)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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