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

Sponsor
Karabuk University (Other)
Overall Status
Completed
CT.gov ID
NCT06135883
Collaborator
(none)
267
Enrollment
1
Location
5.9
Actual Duration (Months)
44.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    267 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluating Folic Acid Awareness and Usage in High-Risk Pregnant Women for Neural Tube Defects
    Actual Study Start Date :
    Feb 20, 2023
    Actual Primary Completion Date :
    Aug 20, 2023
    Actual Study Completion Date :
    Aug 20, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. High awareness level for high-risk pregnant women [up to 12 weeks]

      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.

    2. Low awareness level for society, regardless of the risk situation [up to 12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prof. Dr. Cemil Tascioglu City Hospital Istanbul Sisli Turkey 34384

    Sponsors and Collaborators

    • Karabuk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cagdas Nurettin Emeklioglu, MD, Karabuk University
    ClinicalTrials.gov Identifier:
    NCT06135883
    Other Study ID Numbers:
    • KBU-EMEKLIOĞLU-001
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cagdas Nurettin Emeklioglu, MD, Karabuk University
    neural tube defects
    folic acid
    awareness
    perinatology
    pregnancy
    Additional relevant MeSH terms:
    Neural Tube Defects
    Spinal Dysraphism

    Study Results

    No Results Posted as of Nov 18, 2023