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

NCT06135883 | Completed

• 1 other identifier: KBU-EMEKLIOĞLU-001
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Neural Tube Defects; Folic Acid

Keywords

neural tube defects; folic acid; awareness; perinatology; pregnancy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Sisli, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neural Tube Defects

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: February 20, 2023
• Primary Completion: August 20, 2023
• Study Completion: August 20, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

TU (1)