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临床试验/NCT03429257
NCT03429257已完成不适用

Association Among Maternal Environmental Enteric Dysfunction, Aflatoxin Exposure, and Birth Outcomes: A Prospective Cohort Study in Mukono, Uganda

Tufts University1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
258
试验地点
1
主要终点
Infant Gestational Age at Birth

研究概览

简要总结

This prospective cohort study focuses on the relationship between maternal environmental enteric dysfunction (EED) and maternal aflatoxin B1 exposure and birth outcomes, particularly infant anthropometry and gestational age, in Mukono, Uganda.

详细描述

The problem of stunting, which has long-term health and economic consequences both at the individual and population level, persists in low and middle income countries (LMICs). It has been recognized that an estimated 20% of stunting begins in-utero. Although poor maternal nutrition during pregnancy is often blamed, it has been hypothesized that maternal EED status and maternal aflatoxin exposure during pregnancy may also play a role. However, to date, there have been no studies which have attempted to show the association between EED in pregnant women and negative birth outcomes. Furthermore, few studies have examined the association between maternal aflatoxin exposure during pregnancy and negative birth outcomes.

In this prospective cohort study, pregnant women were enrolled at their first prenatal visit and birth outcome data was assessed within 48 hours of delivery. EED was measured via lactulose: mannitol (L:M) ratios and serum concentrations of antibodies to the bacterial components flagellin and lipopolysaccharide (LPS). Aflatoxin exposure was assessed by measuring the serum concentration of AFB1-lysine adduct from a blood sample taken at enrollment. Data on covariates were obtained from two surveys, one at enrollment and one three weeks prior to participant's estimated date of delivery.

The specific aims of this study were as follows:

  1. To evaluate the relationship between markers of EED in pregnancy and negative birth outcomes, including low birth weight, stunting at birth, small head circumference, and premature delivery.
  2. To evaluate the relationship aflatoxin B1 exposure in pregnancy and negative birth outcomes, including low birth weight, stunting at birth, small head circumference, and premature delivery.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Carrying a singleton pregnancy
  • 18-45 years old
  • Residing within 10 kilometers of Mukono Town

排除标准

  • Younger than 18 years old or older than 45 years old
  • HIV-positive (verified via routine rapid HIV test conducted at first prenatal visit)
  • Severely malnourished (defined as BMI <16.0 kg/m^2)
  • Severely anemic (defined as Hb <7 g/dl)
  • Planning to move away from Mukono District prior to delivery

结局指标

主要结局

Infant Gestational Age at Birth

时间窗: Measured within 48 hours of delivery

Preterm birth \<37 weeks gestation

Infant Birth Weight

时间窗: Measured within 48 hours of delivery

Low birth weight \< 2500 grams

Infant Head Circumference

时间窗: Measured within 48 hours of delivery

Infant Birth Length

时间窗: Measured within 48 hours of delivery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shibani Ghosh

Adjunct Assistant Professor

Tufts University

研究点 (1)

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