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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-04-15

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.

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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.

Conditions

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Neural Tube Defects Bisphenol-A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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pregnancies with neural tube defects

patients with pre-diagnosis of neural tube defects (47 patients).

Group Type OTHER

Bisphenol-A

Intervention Type DIETARY_SUPPLEMENT

measurement of BPA levels in maternal blood and amniotic fluid

pregnancies without neural tube defects

patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients)

Group Type OTHER

Bisphenol-A

Intervention Type DIETARY_SUPPLEMENT

measurement of BPA levels in maternal blood and amniotic fluid

Interventions

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Bisphenol-A

measurement of BPA levels in maternal blood and amniotic fluid

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes