Neural Tube DefectsNCT05454085
Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects
A study testing Bisphenol-A in people with Neural Tube Defects and Bisphenol-A, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Our aim in this study is in patients with a diagnosis of neural tube defect; is the measurement of BPA levels in maternal blood and amniotic fluid. 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, Bisphenol-A
- What is being tested?
- Bisphenol-A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 15 Apr 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients who had a single pregnancy, had a pre-diagnosis of neural tube defect or had amniocentesis between 15 and 22 weeks of age with other indications
- patients had an uncomplicated pregnancy before the procedure
- patients had no vaginal infection
Who cannot join
- Multiple pregnancies,
- pregnant women who developed complications due to amniocentesis
- pregnant women with known infective or autoimmune diseases before pregnancy
- those whose spouses or themselves worked in the plastics industry
- patients who could not obtain enough amniotic fluid despite meeting the study criteria during the study
Trial locations and contacts
1 site in 1 country.
About this study
Our aim in this study is in patients with a diagnosis of neural tube defect; is the measurement of BPA levels in maternal blood and amniotic fluid.
Read the detailed description
This prospective observational study was conducted with 92 patients aged 18 - 45 years who had amniocentesis at 15 - 22 weeks of gestation at Bursa Yüksek İhtisas Training and Research Hospital between April 15, 2021 and April 15, 2022. Patients were divided into two groups according to amniocentesis indications. Group 1: patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients), Group 2: patients with pre-diagnosis of NTD (47 patients). During the amniocentesis procedure, the first 5cc amniotic fluid and maternal serum samples were collected from the patients. The obtained samples were stored at -80°C until the end of the study. After all samples were collected, BPA values were measured by ELISA method.
- Conditions
- Neural Tube Defects, Bisphenol-A
- Being tested
- Bisphenol-A
- Keywords
- Bisfenol A, amniocentesis, neural tube defect
- 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.
Bisphenol-ADietary supplement
measurement of BPA levels in maternal blood and amniotic fluid
| Study group | Role | What they receive |
|---|---|---|
| pregnancies with neural tube defects | Other | patients with pre-diagnosis of neural tube defects (47 patients). Receives: Dietary Supplement: Bisphenol-A |
| pregnancies without neural tube defects | Other | patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients) Receives: Dietary Supplement: Bisphenol-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPA levels
measurement of BPA levels in maternal blood and amniotic fluid
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start15 Apr 2021
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Education and Research Hospital
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454085
- Sponsor's protocol ID
- 2021/02-12
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aytac Bektas N, Yenigul NN, Pakay K, Dincgez B, Yuce Bilgin E, Ustundag Y, Ustunyurt E. Does Bisphenol-A play a role in the development of neural tube defects? J Perinatol. 2024 Jul;44(7):1029-1034. doi: 10.1038/s41372-024-01925-3. Epub 2024 Mar 18.
PubMed 38499756
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects
- ClinicalTrials.gov ID
- NCT05454085
- Acronym / sponsor ID
- 2021/02-12
- Conditions
- Neural Tube Defects, Bisphenol-A
- Keywords
- Bisfenol A, amniocentesis, neural tube defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Education and Research Hospital
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 12 Jul 2022 (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.
Our aim in this study is in patients with a diagnosis of neural tube defect; is the measurement of BPA levels in maternal blood and amniotic fluid.
Detailed description
This prospective observational study was conducted with 92 patients aged 18 - 45 years who had amniocentesis at 15 - 22 weeks of gestation at Bursa Yüksek İhtisas Training and Research Hospital between April 15, 2021 and April 15, 2022. Patients were divided into two groups according to amniocentesis indications. Group 1: patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients), Group 2: patients with pre-diagnosis of NTD (47 patients). During the amniocentesis procedure, the first 5cc amniotic fluid and maternal serum samples were collected from the patients. The obtained samples were stored at -80°C until the end of the study. After all samples were collected, BPA values were measured by ELISA method.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnancies with neural tube defects | Other | Dietary Supplement: Bisphenol-Apatients with pre-diagnosis of neural tube defects (47 patients). |
| pregnancies without neural tube defects | Other | Dietary Supplement: Bisphenol-Apatients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who had a single pregnancy, had a pre-diagnosis of neural tube defect or had amniocentesis between 15 and 22 weeks of age with other indications
- patients had an uncomplicated pregnancy before the procedure
- patients had no vaginal infection
Key exclusion criteria (5 listed)
- Multiple pregnancies,
- pregnant women who developed complications due to amniocentesis
- pregnant women with known infective or autoimmune diseases before pregnancy
- those whose spouses or themselves worked in the plastics industry
- patients who could not obtain enough amniotic fluid despite meeting the study criteria during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisphenol-Ameasurement of BPA levels in maternal blood and amniotic fluid | Dietary supplement | pregnancies with neural tube defects, pregnancies without neural tube defects |
Primary outcome
BPA levels
Time frame: 1 year
measurement of BPA levels in maternal blood and amniotic fluid
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 12 Jul 2022.
- Derived from this study: PubMed 38499756Aytac Bektas N, Yenigul NN, Pakay K, Dincgez B, Yuce Bilgin E, Ustundag Y, Ustunyurt E. Does Bisphenol-A play a role in the development of neural tube defects? J Perinatol. 2024 Jul;44(7):1029-1034. doi: 10.1038/s41372-024-01925-3. Epub 2024 Mar 18.
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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?
A study testing Bisphenol-A in people with Neural Tube Defects and Bisphenol-A, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital 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 3 inclusion and 5 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 12 Jul 2022. 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?
BPA levels (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454085, which also lists 1 linked publication.
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 12 Jul 2022.