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NCT06135883 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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