Influence of Modifiable Factors on the Vaginal Microbiota and Preterm Birth

描述(申请人提供)：早产(PTB)是导致婴儿死亡的主要原因，每年造成数十亿美元的可避免的医疗成本。早产的原因尚不清楚，但被认为是由复杂的人口、生物和行为因素造成的。最近，阴道微生物区系失调--阴道微生物区系紊乱--已被证明与肺结核有关。研究还表明，阴道微生物区系的组成、失调的频率和持续时间可能会受到人口统计学、生物学和行为因素的影响，这些因素是已知的早产预测因素。这项拟议的研究将研究已知与肺结核相关的社会和生物行为因素对阴道微生物区系组成以及阴道微生物失调的频率和持续时间的影响。这项研究的总体目标是阐明社会和生物行为因素、阴道微生物区系和出生妊娠之间的关系。具体目标包括表征社会和生物行为因素对分娩怀孕的影响(目标 1)和阴道微生物区系(目标3)，描述微生物区系对分娩妊娠的影响(目标2)，并量化阴道微生物区系在社会和生物行为因素与分娩妊娠之间的关系中的作用(目标4)。在这项前瞻性队列研究中，400名妇女将被跟踪调查，从怀孕20周到分娩。通过招募来自巴尔的摩市肺结核发病率高于平均水平的社区的孕妇，我们预计至少有16%的队列将经历早产。每周自我采集的中层阴道拭子将使用有效的方案获得。饮食信息、阴道和产前健康行为数据将通过专门为这项研究设计的基于网络的应用程序来收集。结构方程模型和混合效应模型将被用来检验假设。AIMS 1、3和4的样本将包括全部队列，而AIMS 2-4将使用提供早产和年龄匹配对照的病例的子样本。患有肺结核的女性和年龄匹配的对照组的阴道拭子和PH值将使用R16培养独立技术进行分析。这些发现将提供关于可改变的社会和生物行为因素对妊娠期肺结核患者阴道微生物失调的组成、频率和持续时间的影响的基本知识。

DESCRIPTION (provided by applicant): Preterm birth (PTB) is the leading cause of infant mortality and incurs billions of dollars per year in avoidable health costs. The causes of preterm birth are not well understood but are thought to originate from complex demographic, biological and behavioral factors. More recently vaginal dysbiosis - disruptions in the vaginal microbiota - have been shown to be associated with PTB. Studies have also shown that the composition and the frequency and duration of dysbiosis in the vaginal microbiota may be affected by the same demographic, biological and behavioral factors that are known predictors of preterm birth. This proposed study will examine the contribution that social and bio-behavioral factors known to be associated with PTB have on the composition of the vaginal microbiota as well as the frequency and duration of vaginal dysbiosis. The overall goal of this study is to elucidate the relationship between social and bio-behavioral factors, the vaginal microbiota and birth gestation. Specific aims include characterizing the effect of social and bio-behavioral factors on birth gestation (Aim 1) and on the vaginal microbiota (Aim 3), characterizing the effect of the microbiota on birth gestation (Aim 2) and quantifying the role of the vaginal microbiota in the relationship between social and bio-behavioral factors and birth gestation (Aim 4). In this prospective cohort study, 400 women will be followed from 20 weeks gestation through to birth. By recruiting pregnant women from neighborhoods in Baltimore City with higher than average PTB rates we expect that at least 16% of the cohort will experience premature birth. Weekly self-collected mid-level vaginal swabs will be obtained using a validated protocol. Diet information, vaginal and prenatal health behavior data will be collected via a web- based application specifically designed for this study. Structural equation modeling and mixed effects models will be used to test the hypotheses. The sample for Aims 1, 3, and 4 will include the full cohort while Aims 2-4 will use a subsample of cases that deliver preterm and age-matched controls. Vaginal swabs and pH for the women that experience PTB and the age-matched control will be analyzed using r16S culture-independent techniques. Findings will provide essential knowledge about the influence that modifiable social and bio- behavioral factors have on the composition and frequency and duration of vaginal dysbiosis during pregnancy the PTB.