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
About this trial
This is an interventional prevention trial for Neural Tube Defects focused on measuring Bisfenol A, amniocentesis, neural tube defect
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
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
NCT ID
NCT05454085
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
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
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