A Cohort Study Investigating Nutritional Deficiency Among Pregnant Women With History of Recurrent Miscarriage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 499
- 试验地点
- 1
- 主要终点
- Number of participants with miscarriage
研究概览
简要总结
This prospective cohort study primarily aims to examine the association between blood niacin levels and recurrent miscarriage.
详细描述
Recurrent miscarriage is affecting around 5% women at reproductive age. And the underlying causes remain undetermined in 50%-70% of cases. Although animal models and linkage analysis according to family studies have identified that niacin deficiency can lead to congenital malformations and recurrent miscarriage. Evidence based on population is lacking with regard to the effect of blood niacin levels on recurrent miscarriage. We intend to enroll 499 pregnant women confirmed by a positive blood human chorionic gonadotropin test and with history of unexplained recurrent miscarriage. By testing their blood niacin levels and following up to the end of first-trimester pregnancy, this study aims to examine the role of niacin levels in preventing miscarriages among women with history of recurrent miscarriage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-40years old, female
- •Positive blood human chorionic gonadotropin test
- •Naturally pregnant
- •History of recurrent miscarriage (2 or more consecutive spontaneous miscarriage within 28 weeks of gestation)
- •Willing to participate in this study with informed consent
排除标准
- •Women whose confirmed cause of recurrent miscarriage has nothing to do with nutritional deficiencies, including chromosomal abnormalities, abnormal uterine anatomy, immune system diseases, blood diseases, etc.
- •Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
- •Women with serious conditions, such as schizophrenia, tumors, heart failure
结局指标
主要结局
Number of participants with miscarriage
时间窗: 6-13(+6) weeks of gestation
pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
Gestation week at miscarriage
时间窗: 6-13(+6) weeks of gestation
pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
次要结局
未报告次要终点
