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

NCT05454085 | Completed

• 1 other identifier: 2021/02-12
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Neural Tube Defects; Bisphenol-A

Keywords

Bisfenol A; amniocentesis; neural tube defect

Outcome Measures

Primary Outcomes (1)

• BPA levels

  measurement of BPA levels in maternal blood and amniotic fluid

  1 year

Study Arms (2)

pregnancies with neural tube defects

OTHER

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

Dietary Supplement: Bisphenol-A

pregnancies without neural tube defects

OTHER

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

Dietary Supplement: Bisphenol-A

Interventions

Bisphenol-A DIETARY_SUPPLEMENT

measurement of BPA levels in maternal blood and amniotic fluid

pregnancies with neural tube defects; pregnancies without neural tube defects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead
• Bursa Yuksek Ihtisas Education and Research Hospital: collaborator

Study Sites (1)

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neural Tube Defects

Interventions

Bisphenols

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Associet Professor Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: April 15, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

TU (1)