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

Ottawa Hospital Research Institute

Status: Completed

Conditions: Behavioural Problem; Pre-Eclampsia; Death; Asthma; Autism Spectrum Disorder; Emotional Problem; Executive Dysfunction

Treatments: Diagnostic Test: SRS 2, CBCL, BRIEF-P

Study type: Observational

Funder types: Other

Identifiers

NCT03269110

CTO 816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 664 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: 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

Trial design

664 participants in 1 patient group

Mother and child(ren)

Description:

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.

Treatment:

Diagnostic Test: SRS 2, CBCL, BRIEF-P