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OpenTrials
Completed

NCT Number: NCT05454085

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bisphenol-A

Dietary Supplement

measurement of BPA levels in maternal blood and amniotic fluid

Primary outcomes

  1. BPA levels

    Time frame: 1 year

    measurement of BPA levels in maternal blood and amniotic fluid

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Collaborators

  • Bursa Yuksek Ihtisas Education and Research Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2022
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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