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

July 11, 2022 updated by: Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16110
        • Nefise Nazlı YENIGUL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: pregnancies with neural tube defects
patients with pre-diagnosis of neural tube defects (47 patients).
Dietary supplement: Bisphenol-A
measurement of BPA levels in maternal blood and amniotic fluid
Other: pregnancies without neural tube defects
patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients)
Dietary supplement: Bisphenol-A
measurement of BPA levels in maternal blood and amniotic fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BPA levels
Time Frame: 1 year
measurement of BPA levels in maternal blood and amniotic fluid
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Collaborators

Bursa Yüksek İhtisas Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/02-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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