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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05454085

Enrollment

Registered

2022-07-12

Start date

2021-04-15

Completion date

2022-04-15

Last updated

2022-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bisphenol-A, Neural Tube Defects

Keywords

Bisfenol A, amniocentesis, neural tube defect

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTBisphenol-A

measurement of BPA levels in maternal blood and amniotic fluid

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
BPA levels	1 year	measurement of BPA levels in maternal blood and amniotic fluid

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026