search
Back to results

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

Primary Purpose

Neural Tube Defects, Bisphenol-A

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bisphenol-A
Sponsored by
Sanliurfa Mehmet Akif Inan Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neural Tube Defects focused on measuring Bisfenol A, amniocentesis, neural tube defect

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Nefise Nazlı YENIGUL

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

pregnancies with neural tube defects

pregnancies without neural tube defects

Arm Description

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

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

Outcomes

Primary Outcome Measures

BPA levels
measurement of BPA levels in maternal blood and amniotic fluid

Secondary Outcome Measures

Full Information

First Posted
July 7, 2022
Last Updated
July 11, 2022
Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Collaborators
Bursa Yuksek Ihtisas Education and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05454085
Brief Title
Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects
Official Title
Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Collaborators
Bursa Yuksek Ihtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neural Tube Defects, Bisphenol-A
Keywords
Bisfenol A, amniocentesis, neural tube defect

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pregnancies with neural tube defects
Arm Type
Other
Arm Description
patients with pre-diagnosis of neural tube defects (47 patients).
Arm Title
pregnancies without neural tube defects
Arm Type
Other
Arm Description
patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients)
Intervention Type
Dietary Supplement
Intervention Name(s)
Bisphenol-A
Intervention Description
measurement of BPA levels in maternal blood and amniotic fluid
Primary Outcome Measure Information:
Title
BPA levels
Description
measurement of BPA levels in maternal blood and amniotic fluid
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Nefise Nazlı YENIGUL
City
Bursa
ZIP/Postal Code
16110
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs