Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- 1. Differences in vaginal and gut microbiome and urinary metabolites profile between obese and nonobese pregnant AA women
研究概览
简要总结
- Determine if the stool or vaginal microbiome and urinary metabolite profiles in a pregnant obese population of African American women differ from their pregnant non-obese counterparts
- Determine if the stool or vaginal microbiome and urinary metabolite profiles vary by class of obesity and magnitude of excess weight gain in this population of pregnant African-American women.
- Assess the ability of the stool, vaginal microbiome, or metabolites, or the combination of all biomarkers as predictors of preterm birth (PTB) and onset of labor.
- Determine if any dietary or clinical variables are correlated with changes in the microbiome or urinary metabolites or modify their association with PTB
详细描述
This is an exploratory pilot study to determine the omic footprint in pregnant AA women and then compare difference between obese and non-obese pregnant AA women and comparisons by class of obesity. Variations in the omic findings (vaginal and gut microbiome and urinary metabolites) will be assessed by dietary findings and by variations in gestational weight gain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
No masking. A convenience sample of pregnant AA women will be recruited based on race/ethnicity and body mass index.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 20 or older English Speaking Access to internet- The dietary assessment for this study is The Automated Self-Administered 24-hour Recall (ASA24-2014), a web-based instrument developed by researchers at the National Cancer Institute (NCI).
排除标准
- •History of preterm birth and taking progesterone. Progesterone may influence the microbiota and metabolites so therefore these women will not be eligible for the study. However, if the women fit other inclusion criteria and have a history of preterm birth but are not on progesterone they will be eligible for enrollment
- •History of antibiotic use in the last month (includes pre-biotics and probiotics). These medications will change the baseline microbiota.
- •History of chronic disease on medications
研究组 & 干预措施
Pregnant Obese African American Women
Exploratory
干预措施: Exploratory (Other)
结局指标
主要结局
1. Differences in vaginal and gut microbiome and urinary metabolites profile between obese and nonobese pregnant AA women
时间窗: 27-28 weeks to 39 weeks of pregnancy
The vaginal and gut microbiome and urine metabolites in obese women AA women will be compared with non-obese pregnant AA women. This comparison will be investigated by diet and gestational weight gain
次要结局
- Differences in vaginal and gut microbiome and urinary metabolites profile between by class of obesity in pregnant AA women(27-28 weeks to 39 weeks of pregnancy)
研究者
Mary Ann Faucher
Associate Professor
Baylor University