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

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Status: Completed

Conditions: Neural Tube Defects; Bisphenol-A

Treatments: Dietary Supplement: Bisphenol-A

Study type: Interventional

Funder types: Other

Identifiers

NCT05454085

2021/02-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

pregnancies with neural tube defects

Other group

Description:

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

Treatment:

Dietary Supplement: Bisphenol-A

pregnancies without neural tube defects

Other group

Description:

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

Treatment:

Dietary Supplement: Bisphenol-A