Neural Tube DefectsNCT06135883
Assessing Folic Acid in High-Risk Pregnancy for Neural Tube Defects
An observational study of Neural Tube Defects and Folic Acid, run by Karabuk University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neural Tube Defects, Folic Acid
- How many people
- 267 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2023to 20 Aug 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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
Who cannot join
- under 18 years old
- Above 45 years old
- Multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, Sisli, 34384
About this study
Official title: 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.
- Conditions
- Neural Tube Defects, Folic Acid
- Keywords
- neural tube defects, folic acid, awareness, perinatology, pregnancy
- Medical subject headings
- Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Feb 2023
- Primary completion20 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 267 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagdas Nurettin Emeklioglu, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135883
- Sponsor's protocol ID
- KBU-EMEKLIOĞLU-001
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Folic Acid Awareness and Usage in High-Risk Pregnant Women for Neural Tube Defects
- ClinicalTrials.gov ID
- NCT06135883
- Acronym / sponsor ID
- KBU-EMEKLIOĞLU-001
- Conditions
- Neural Tube Defects, Folic Acid
- Keywords
- neural tube defects, folic acid, awareness, perinatology, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- under 18 years old
- Above 45 years old
- Multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neural Tube Defects and Folic Acid, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High awareness level for high-risk pregnant women (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.