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临床试验/NCT05267678
NCT05267678招募中不适用

A Cohort Study Investigating Nutritional Deficiency Among Pregnant Women With History of Recurrent Miscarriage

Westlake University1 个研究点 分布在 1 个国家目标入组 499 人开始时间: 2023年1月28日最近更新:
适应症

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

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

研究者

发起方
Westlake University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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