Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)

Ottawa Hospital Research Institute (Other)
Overall Status
Unknown status ID

Study Details

Study Description

Brief Summary

FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high dose folic acid supplementation on social impairments associated with Autism Spectrum Disorders (ASDs), and deficiencies in a range of executive function and emotional and behavioural problems in young children, and the risk of death.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: SRS 2, CBCL, BRIEF-P

Detailed Description

The Folic Acid Clinical Trial (FACT) was developed to conclusively determine the effect of high dose folic acid supplementation in pregnancy on the prevention of preeclampsia in a randomized controlled trial (RCT) design.

The primary objective of the FACT 4 Child study is to examine the effect of maternal folic acid supplementation in pregnancy on the risk of social impairments, as well as executive function, emotional and behavioural problems associated with Autism Spectrum Disorders (ASD) and other developmental disorders, and death in offspring aged 4-6 y of mothers recruited to the CIHR funded FACT.

The effect of folic acid supplementation throughout pregnancy may potentially have an impact on both the mother and her offspring, which highlights the importance and relevance of this study to the management of women with preeclampsia. Results of this study will allow care providers to have the evidence of potential effects of high dose folic acid that can then be discussed; allowing women to make an informed choice about their management and care.

Study Design

Study Type:
Anticipated Enrollment :
2578 participants
Observational Model:
Time Perspective:
Official Title:
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Actual Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Mother and child(ren)

FACT 4 Child is the post-delivery follow-up of the offspring born to FACT mothers once these children are between the age of 4 - 6 years.

Diagnostic Test: SRS 2, CBCL, BRIEF-P
This study does not involve an intervention.

Outcome Measures

Primary Outcome Measures

  1. Neurocognitive disability [From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.]

    The primary outcome is a competing composite endpoint of neurocognitive disability and death. Neurocognitive disability is a composite outcome related to social impairments, executive function, emotional and behavioural problems which have been associated with Autism Spectrum Disorder (ASD). It will be defined by an abnormal score on any of three standardized and validated assessment tools: SRS-2 BRIEF-P, or CBCL which will be administered to the parents of children aged 4-6 years. Deaths reported between 6 weeks to 4-6 years of age will be recorded as a competing event and treated as part of the primary endpoint.

Secondary Outcome Measures

  1. Severe Morbidity [From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.]

    Secondary outcomes to be assessed in FACT 4 Child include severe morbidity of FACT offspring, captured by the Mother-Child Health Survey at the age of 4 - 6 years, including incidence of: Severe morbidity defined by any illnesses during the previous years that has necessitated hospitalization or medication/treatment for >2 months

Eligibility Criteria


Ages Eligible for Study:
4 Years to 6 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  1. Capability of participant to comprehend and comply with study requirements

  2. Mother participated in FACT

Exclusion Criteria:
  1. Confirmed spontaneous termination (miscarriage) or elective termination or stillborn

  2. Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital

Contacts and Locations


Site City State Country Postal Code
1 Nepean Penrith New South Wales Australia 2750
2 Townsville Douglas Queensland Australia 4814
3 Ipswich Ipswich Queensland Australia 4305
4 Women's and Children's Hospital Adelaide South Australia Australia
5 Royal Women's Parkville Victoria Australia 3052
6 Sunshine St Albans Victoria Australia 3021
7 Calgary Foothills Medical Center Calgary Alberta Canada T2N2T9
8 Edmonton Lois Hole Hospital for Women Edmonton Alberta Canada T5H 3V9
9 St-Paul's Hospital Vancouver British Columbia Canada V6Z 2K5
10 Winnipeg University of Manitoba Winnipeg Manitoba Canada R3E 3P4
11 Fredericton Dr. Everett Chalmers Regional Hospital Fredericton New Brunswick Canada E3B 5N5
12 Moncton Hospital Moncton New Brunswick Canada E1C 6Z8
13 St-John's Women's Health Centre St John's Newfoundland and Labrador Canada A1B 3V6
14 Hamilton McMaster University Hamilton Ontario Canada L8S 4K1
15 Kingston Kingston Ontario Canada K7L 2V7
16 London London Ontario Canada N6A 5W9
17 The Ottawa Hospital, General Campus Ottawa Ontario Canada K1H 8L6
18 The Ottawa Hospital, Civic Campus Ottawa Ontario Canada K1Y 4E9
19 Sunnybrook Health Sciences Toronto Ontario Canada M4N 3M5
20 Quebec City (CHUL) Centre Hospitalier Universitaire Montreal Quebec Canada G1V 4G2
21 Sainte-Justine Montreal Quebec Canada H3T 1C5
22 St-Mary's Hospital Montreal Quebec Canada H3T 1M5
23 St-Luc Montreal Quebec Canada
24 Regina Qu'Appelle Health Region Regina Saskatchewan Canada S4P 0W5
25 University of West Indies Kingston 7 Jamaica
26 Jubilee Kingston Jamaica
27 Spanishtown Kingston Jamaica
28 Hinchingbrooke Huntingdon Cambridgeshire United Kingdom PE29 6NT
29 Leighton Crewe Cheshire United Kingdom CW1 4QJ
30 Darlington Memorial Hospital Darlington County Durham United Kingdom DL3 6HX
31 Fairfield Bury Lancashire United Kingdom BL9 7TD
32 Rochdale Rochdale Lancashire United Kingdom OL12 0NB
33 Lincolnshire Lincoln Lincolnshire United Kingdom LN2 4AX
34 West Middlesex University Hospital Isleworth Middlesex United Kingdom TW7 6AF
35 Wansbeck General Hospital Ashington Northumberland United Kingdom NE63 9JJ
36 St George's Hospital London Tooting United Kingdom SW17 0QT
37 Gateshead Queen Elizabeth Hospital Gateshead Tyne And Wear United Kingdom NE9 6SX
38 South Tyneside Distrcit Hospital South Shields Tyne And Wear United Kingdom NE34 0PL
39 Blackburn Blackburn United Kingdom BB2 3HH
40 Burnley Burnley United Kingdom BB10 2PQ
41 Cumberland Infirmary Carlisle Carlisle United Kingdom
42 North Manchester Crumpsall United Kingdom M8 5RB
43 North Durham Durham United Kingdom
44 Guy's and St. Thomas London United Kingdom
45 South Tees Hospital Middlesbrough United Kingdom TS4 3BW
46 Newcastle upon Tyne Hospitals Newcastle upon Tyne United Kingdom NE1 4LP
47 North Tyneside General Hospital North Shields United Kingdom NE29 8NH
48 Norfolk & Norwich Norwich United Kingdom
49 Nottingham City Hospital Nottingham United Kingdom NG5 1PB
50 Nottingham Queens Medical Centre Nottingham United Kingdom NG7 2UH
51 Oldham Oldham United Kingdom OL1 2JH
52 North Tees Hospital Stockton United Kingdom TS19 9AH
53 Sunderland Royal Hospital Sunderland United Kingdom SR4 7TP
54 Hillingdon Hospital Uxbridge United Kingdom UB8 3NN
55 Warrington Hospital Warrington United Kingdom
56 West Cumberland Hospital Whitehaven United Kingdom
57 49 Marine Avenue Whitley Bay United Kingdom
58 Royal Wolverhampton - New Cross Hospital Wolverhampton United Kingdom

Sponsors and Collaborators

  • Ottawa Hospital Research Institute


  • Principal Investigator: Mark Walker, MD, The Ottawa Hospital

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Ottawa Hospital Research Institute Identifier:
Other Study ID Numbers:
  • CTO 816
First Posted:
Aug 31, 2017
Last Update Posted:
Aug 6, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Ottawa Hospital Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2020