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

November 13, 2023 updated by: Cagdas Nurettin Emeklioglu, Karabuk University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- Sisli
  - Istanbul, Sisli, Turkey, 34384
    - Prof. Dr. Cemil Tascioglu City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High awareness level for high-risk pregnant women Time Frame: 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.	up to 12 weeks
Low awareness level for society, regardless of the risk situation Time Frame: up to 12 weeks	Low folic acid knowledge and awareness in the sample groups, regardless of risk status	up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karabuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Actual)

August 20, 2023

Study Completion (Actual)

August 20, 2023

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)