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

Neural Tube Defects Clinical Trial

Official title:

Evaluating Folic Acid Awareness and Usage in High-Risk Pregnant Women for Neural Tube Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06135883
• Other study ID #: KBU-EMEKLIOGLU-001
• Status: Completed
• Start date: February 20, 2023
• Est. completion date: August 20, 2023

Study information

• Verified date: November 2023
• Source: Karabuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: August 20, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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:

• under 18 years old

• Above 45 years old

• Multiple pregnancies

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism

Locations

Country	Name	City	State
Turkey	Prof. Dr. Cemil Tascioglu City Hospital	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 12 weeks
Primary	Low awareness level for society, regardless of the risk situation	Low folic acid knowledge and awareness in the sample groups, regardless of risk status	up to 12 weeks