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

Not Applicable

Completed

• Conditions: Bisphenol-A; Neural Tube Defects
• Interventions: Dietary Supplement: Bisphenol-A

• Registration Number: NCT05454085
• Lead Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

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.

Study Timeline

• Study Start: 2021-04-15
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Status Verified: 2022-07
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-11
• Last Update Submitted: 2022-07-11
• Study First Posted: 2022-07-12
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregnancies with neural tube defects	Bisphenol-A	patients with pre-diagnosis of neural tube defects (47 patients).
pregnancies without neural tube defects	Bisphenol-A	patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients)

Primary Outcome Measures

Name	Time	Method
BPA levels	1 year	measurement of BPA levels in maternal blood and amniotic fluid

Trial Locations

Locations (1)

Nefise Nazlı YENIGUL; 🇹🇷 Bursa, Turkey