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Folic Acid and Maternal Health Study

Folic Acid and Maternal Health Study (Gestational Diabetes and Importance of Folic Acid)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001243404
Acronym
FAMH
Enrollment
1000
Registered
2025-11-07
Start date
2025-11-17
Completion date
2027-07-31
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this project, our research seeks to understand how very high levels of folic acid during pregnancy might contribute to an increased risk of developing gestational diabetes. In previous research, we have found that very high folate levels in early pregnancy may affect the placental hormones of the mother. We think this may increase the risk of developing gestational diabetes. We need to identify and understand how these factors contribute to gestational diabetes.

Interventions

In Australia, pregnant people are increasingly exposed to high doses of folic acid via supplements and fortified foods. Evidence suggests that some are getting higher than the daily tolerable limit and this may contribute to increasing incidence of gestational diabetes. This observational study will record the total amounts and duration of folic acid consumed in pregnancy via supplements at 14 and 32 weeks' gestation and calculated dietary intake from a food frequency questionnaire (Australian E

In Australia, pregnant people are increasingly exposed to high doses of folic acid via supplements and fortified foods. Evidence suggests that some are getting higher than the daily tolerable limit and this may contribute to increasing incidence of gestational diabetes. This observational study will record the total amounts and duration of folic acid consumed in pregnancy via supplements at 14 and 32 weeks' gestation and calculated dietary intake from a food frequency questionnaire (Australian Eating Survey) administered in early pregnancy. Pregnancy and birth outcomes, including gestational diabetes, will be recorded and assessed in relatiuonship to folic acid intake and quantified blood levels. Participants will be required to complete a series of 9 short questionnaires, anticipating 45-50mins to complete, approx. 5 min per questionnaire. 8 questionnaires will be sent at enrolment of study at 10-14 weeks gestation and 1 follow-up questionnaire sent at 32 weeks. There is no requirement for study visits. All questionnaires can be completed online, at the participants convenience, through a secure email link. There will be 2 timepoints for participants to provide extra blood and urine samples. A fasting blood and urine sample between 10-14 weeks and a second blood sample at 28 weeks coinciding with their routine pregnancy blood tests. All other data relating to current pregnancy and outcomes will be accessed through medical records. The overall duration of observation will be from 10-14 weeks gestation until 4 weeks post birth.

Sponsors

Flinders University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 43 Years
Healthy volunteers
No

Inclusion criteria

Women with singleton pregnancy birthing at Flinders Medical Centre Less than 16 weeks gestation

Exclusion criteria

diagnosis of diabetes pre pregnancy twin or other multiple pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026