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

Neural Tube Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05454085
• Other study ID #: 2021/02-12
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: July 2022
• Source: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism

Intervention

Dietary Supplement:
• Bisphenol-A
measurement of BPA levels in maternal blood and amniotic fluid

Locations

Country	Name	City	State
Turkey	Nefise Nazli YENIGUL	Bursa

Sponsors (2)

Lead Sponsor	Collaborator
Sanliurfa Mehmet Akif Inan Education and Research Hospital	Bursa Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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