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临床试验/NCT01647841
NCT01647841已完成不适用

Maternal Determinants of HIV-exposed and HIV-unexposed Fetal Growth, Birth Outcomes and Early Infant Growth

Cornell University1 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
218
试验地点
1
主要终点
Maternal cachexia score

研究概览

简要总结

The purpose of this study is to understand how differences in the nutritional status and concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant women living in a semi-rural and rural region of northern Tanzania affect fetal growth, pregnancy outcomes and early infant health and development. The study hypothesis is that HIV+ women will have worse nutritional status and a greater degree of cachexia which will negatively impact fetal growth, pregnancy outcomes and early infancy health and development.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Informed consent provided by mothers, and parental consent on behalf of their infants
  • Confirmed HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
  • Estimated gestational age between 12th and 34th weeks
  • Stated intention to remain in the clinic catchment area ≥6 months post-partum
  • Singleton birth

排除标准

  • 未提供

结局指标

主要结局

Maternal cachexia score

时间窗: Up to 1 month post-partum

次要结局

  • Maternal anthropometric measures(Up to 1 month post-partum)
  • Fetal growth(Up to 1 month post-partum)
  • Pregnancy outcomes(Up to 1 month post-partum)
  • Early infant anthropometrics(Up to 1 month post-partum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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