ANIRVID: Screening for Perinatal Depression Using Point of Care Device, Metabolomics and Conventional Techniques.
试验速览
- 阶段
- 不适用
- 状态
- Other
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- To monitor depression in pregnant women using point-of-care device.
研究概览
简要总结
Perinatal depression is highly prevalent and is an important public health problem as it affects both the mother and the newborn baby. Early detection of perinatal depression is hence necessary for the benefit of both mother and child in the society. The main goal of this multi-center study is to develop a rapid, hand-held, mobile-health point-of-care diagnostic device, for monitoring key biomarkers related to depression in pregnant women (both during pregnancy and postnatal periods) at low-cost than current existing systems. We will achieve biomarker validation (leading to biomarker discovery) in this study with the use of metabolomics. In addition to the development and validation of this indigenously developed device on the concerned patient population, the proposed study will facilitate early diagnosis, prognosis and modification in the management of depression for the benefit of pregnant women and mothers in the society.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant Women inclusion criteria: 18 to 40 years of age Non-pregnant women inclusion criteria (for baseline samples): 18 to 40 years of age.
排除标准
- •Pregnant women exclusion criteria: those who are already on psychotropic medication.
- •Non-pregnant women exclusion criteria (for baseline samples): those who are already on psychotropic medication and those who have a baby of less than 2 years old.
结局指标
主要结局
To monitor depression in pregnant women using point-of-care device.
时间窗: Samples from the pregant women are collected twice before the delivery (one between 24-28 weeks and one during 36-38 weeks of gestational period) and four times after deliver, i.e., 1st day, 7th day, 14th day and 3 months after delivery. | The baseline sample collection from the non-pregnant women participants will be taken only once.
Achieve biomarker validation / discovery with the use of metabolomics.
时间窗: Samples from the pregant women are collected twice before the delivery (one between 24-28 weeks and one during 36-38 weeks of gestational period) and four times after deliver, i.e., 1st day, 7th day, 14th day and 3 months after delivery. | The baseline sample collection from the non-pregnant women participants will be taken only once.
次要结局
- Facilitate the early diagnosis and management of depression in pregnant women and mothers.