Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects

Conditions
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Neural Tube Defects, Bisphenol-A

Intervention / Treatment
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* Dietary Supplement: Bisphenol-A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pregnancies with neural tube defects<br>patients with pre-diagnosis of neural tube defects (47 patients). | Dietary Supplement: Bisphenol-A<br>* measurement of BPA levels in maternal blood and amniotic fluid<br>|
| Other: pregnancies without neural tube defects<br>patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients) | Dietary Supplement: Bisphenol-A<br>* measurement of BPA levels in maternal blood and amniotic fluid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BPA levels | measurement of BPA levels in maternal blood and amniotic fluid | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bisfenol A, amniocentesis, neural tube defect