Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- BPA levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
BPA levels
时间窗: 1 year
measurement of BPA levels in maternal blood and amniotic fluid
次要结局
未报告次要终点
研究者
Nefise Nazlı YENIGUL
Ph.D. Associet Professor Department of Obstetrics and Gynecology
Sanliurfa Mehmet Akif Inan Education and Research Hospital