CTRI/2024/06/069174招募中不适用
Impact of Air Pollution on Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- NA
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- 1. Pregnancy Outcomes: Placental Abnormities, Intrauterine Growth restriction etc.
研究概览
简要总结
| This prospective cohort study endeavors to examine the association between maternal exposure to air pollution during the gestational period and the emergence of adverse pregnancy and birth outcomes. The study site will be B.J. Medical College & Civil hospital, Ahmedabad. Based on inclusion and exclusion criteria pregnant women in the advanced stage of their third trimester, coinciding with their delivery date will be enrolled. Informed consent will be obtained from them and baseline data will be collected. Simultaneously air pollution data of various selected locations will be procured from the Central Pollution Control Board. The participating women will be divided into two groups: controlled group and exposed group based on their area of residence. The area of residence will be categorized on the basis of acceptance limit of pollutant as per National Ambient Air Quality Standards. The samples of maternal blood/cord blood will be collected before/after delivery and small placental tissue will be collected after delivery. Inflammatory, and molecular marker as well as pollutant assessment will be carried out in the biological samples for understanding the physiological reactions to pollutant exposure and its related adverse outcomes. |
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pregnant women from specific selected locations.
- •2.Patients willing to provide Informed consent.
排除标准
- •1.Pregnant via assisted reproductive technology.
- •2.Pregnant women before pregnancy if diagnosed with any of the following pre-existing conditions diabetes, hypertension, or thyroid disorder etc.
- •3.Pregnant women with pre-existing tobacco, drug, alcohol, or smoking habits will be excluded.
- •4.Pregnant women opting for cord blood banking.
结局指标
主要结局
1. Pregnancy Outcomes: Placental Abnormities, Intrauterine Growth restriction etc.
时间窗: At the baseline.
2. Birth Outcomes: Preterm Birth, Still Birth, Low Birth Weight, and Small for gestational Age, Birth defects, Weight of baby, Head Circumference, Apgar Score etc.
时间窗: At the baseline.
次要结局
- Inflammatory and Molecular Markers as well as Heavy Metal Analysis.(At the baseline.)
研究者
Dr Bhoomika Patel
National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat
研究点 (1)
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