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CompletedNCT06135883Updated Nov 18, 2023

Assessing Folic Acid in High-Risk Pregnancy for Neural Tube Defects

An observational study in Neural Tube Defects and Folic Acid, sponsored by Karabuk University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Karabuk University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
267
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Aim of this study is to investigate and statistically reveal the prevalence and awareness of folic acid usage in pregnant women who have at least one of the risk factors for neural tube defects, to express the level of knowledge of the determined population on this subject and to present ideas to increase awareness in the society.

02

Conditions studied

  • Neural Tube Defects
  • Folic Acid

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Keywords

  • neural tube defects
  • folic acid
  • awareness
  • perinatology
  • pregnancy
03

In context

Neural Tube Defects

52 studies on the registry are indexed under Neural Tube Defects; 11 are open to participants now.

This study's enrollment of 267 is above the median of 123 across 24 observational studies indexed under Neural Tube Defects.

Browse Neural Tube Defects studies →

Lead sponsor

Karabuk University is the lead sponsor of 131 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Singleton pregnant women over the age of 18 and under the age of 45 who have at least one of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth history with aneuploidy, history of GDM or known DM).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • over 18 years
  • Under 45 years of age
  • Having at least one of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth defect with aneuploidy, history of GDM or known DM) for Case Group.
  • Singleton pregnant women

Exclusion criteria

Exclusion Criteria:

  • under 18 years old
  • Above 45 years old
  • Multiple pregnancies
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
267 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Case

    Singleton pregnant women over the age of 18 and under the age of 45 who have at least one of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth history with aneuploidy, history of GDM or known DM).

  • Control

    Singleton pregnant women over 18 years of age and under 45 years of age who do not have any risk factors for neural tube defects

06

What researchers measure

Primary outcomes

  1. High awareness level for high-risk pregnant women

    Pregnant women with at least one risk factor for neural tube defects have statistically higher folic acid use and awareness than control group pregnant women.

    Time frame: up to 12 weeks

  2. Low awareness level for society, regardless of the risk situation

    Low folic acid knowledge and awareness in the sample groups, regardless of risk status

    Time frame: up to 12 weeks

07

Study locations

1 site
  • Prof. Dr. Cemil Tascioglu City Hospital
    Istanbul, Sisli 34384, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2023 to primary completion in Aug 2023, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2023
First posted
Nov 18, 2023
StartActual
Feb 20, 2023
Primary completionActual
Aug 20, 2023
CompletionActual
Aug 20, 2023
Last update
Nov 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06135883
Lead sponsor
Karabuk University
Responsible party
Cagdas Nurettin Emeklioglu (MD, Karabuk University) — Principal investigator
First posted
Nov 18, 2023
Start date
Feb 20, 2023
Primary completion
Aug 20, 2023
Completion
Aug 20, 2023
Last update
Nov 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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