Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care (PIINC) Study

心理社会干预、孕产妇炎症和出生结果：集中与常规产前护理 (PIINC) 研究

• 批准号: 10377450
• 负责人: Ann E.B. Borders
• 金额: $ 59.83万
• 依托单位: NORTHSHORE UNIVERSITY HEALTHSYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-13 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10377450
• 关键词: Address; Affect; African American; Anti-Inflammatory Agents; Anxiety; Basic Science; Behavioral; Biological; Biological Markers; Biopsy; Birth; Birth Rate; Blood; Blood Circulation; Caucasians; Characteristics; Chronic; Collection; Data; Developed Countries; Education; Enrollment; Ethnic Origin; Etiology; Frequencies; Gene Expression; Gene Expression Profile; Glucocorticoids; Goals; Growth; Health behavior; Healthcare; Histologic; Histology; IL6 gene; IL8 gene; Immune; Infant Mortality; Inflammation; Inflammatory; Infrastructure; Interleukin-10; Interleukin-13; Intervention; Knowledge; Lesion; Life Style; Link; Logistics; Low Income Population; Low income; Maternal-Fetal Exchange; Mediating; Mediation; Medical Care Costs; Minority Women; Modeling; Mothers; Outcome; Parents; Pathologic; Pathway interactions; Patients; Perinatal; Pilot Projects; Placenta; Pregnancy; Pregnancy Outcome; Premature Birth; Prenatal care; Process; Psychosocial Factor; Public Health; RNA; Race; Randomized; Randomized Controlled Trials; Research; Resources; Risk; Sampling; Scientific Advances and Accomplishments; Signal Transduction; Smoking; Social support; South Carolina; Specimen; Suggestion; Surveys; TNF gene; Transcript; United States; Woman; adverse birth outcomes; adverse outcome; adverse pregnancy outcome; base; behavior measurement; care systems; cohort; design; fetal; gestational weight gain; group intervention; health assessment; hypothalamic-pituitary-adrenal axis; improved; inflammatory milieu; intervention program; lifestyle factors; maternal serum; maternal stress; nutrition; perceived stress; perinatal outcomes; psychologic; psychosocial; racial disparity; randomized trial; routine care; screening program; social disadvantage; social disparities; socioeconomics; theories; trial design; uptake

1 Preterm birth (PTB) rates are substantially higher in the United States than in other industrialized nations, 2 and are disproportionately greater among-low income and minority women. These disparities have proven 3 difficult to ameliorate despite intensive efforts. However, recent studies indicate that a group-based model of 4 prenatal care (GPNC), CenteringPregnancy, significantly reduces PTB in low-income, minority women. 5 CenteringPregnancy is a multifaceted group intervention that integrates three aspects of prenatal care: health 6 assessment, education, and social support. However, little is known about the mechanisms by which GPNC 7 reduces PTB, since the biologic pathways leading to PTB are still incompletely understood. One well- 8 supported theory posits excessive inflammatory activity in maternal circulation and the maternal-fetal interface 9 as an etiology for PTB. Our group and others have linked adverse socioeconomic conditions and maternal 10 psychosocial functioning with circulating inflammatory biomarkers, chronic placental inflammation, and adverse 11 pregnancy outcomes. GPNC may reduce PTB by reducing systemic and placental inflammatory activity 12 through improved psychosocial functioning of women in socially disadvantaged conditions. In a pilot study, we 13 found evidence suggesting that GPNC ameliorates socioeconomic differences in placenta inflammatory lesions 14 and gene expression profiles.Though promising, replication of these results in a larger cohort is needed in 15 order to identify psychological, behavioral and biological mechanisms through which GPNC affects 16 inflammatory activity at the maternal-fetal interface,utilize placental gene expression to evaluate alternate 17 biologic pathways and to clarify the implications of these changes for reduction of PTB disparities. 18 Here, we propose to address these questions by leveraging an existing trial in Greenville, South Carolina 19 (1R01HD082311) that will enroll 3160 women from a predominantly low-income population. The parent study 20 employs a randomized controlled trial design to compare GPNC with traditional prenatal care, and is 21 adequately powered to detect differences in PTB by intervention and race. The parent study will collect and 22 analyze survey measures of behavioral and psychosocial outcomes, but it does not have the resources to 23 collect biomarkers or evaluate biologic mechanisms of action. The goal of this proposal is to add biospecimen 24 collection to the existing trial in order to understand whether GPNC, by improving psychosocial and behavioral 25 functioning, influences the inflammatory milieu during gestation. Specimens will be collected from 1150 women 26 and full analysis performed on a random subset of 900, with the aims of (1) quantifying differences in systemic 27 inflammatory biomarkers, placental histologic inflammation, and placental gene expression between women 28 participating in GPNC and those receivng routine prenatal care and (2) determining whether these differences 29 are mediated by improvements in psychosocial functioning and/or lifestyle characteristics. Ultimately, we aim to 30 understand the biological mechanisms through which GPNC reduces the frequency of PTB.

1美国的早产率（PTB）比其他工业化国家高得多， 2，低收入和少数民族妇女的比例更大。这些差距已经证明 3尽管付出了巨大的努力，但仍难以改善。然而，最近的研究表明，一个基于群体的模型， 4产前护理（GPNC），CenteringPregnancy，显著降低低收入，少数民族妇女的PTB。 5 CenteringPregnancy是一个多方面的团体干预，它整合了产前护理的三个方面： 6评估、教育和社会支持。然而，人们对GPNC的机制知之甚少， 7减少了PTB，因为导致PTB的生物学途径仍然不完全清楚。一口井- 8支持的理论假定母体循环和母胎界面中的过度炎症活动 9作为PTB的病因。我们的团队和其他人将不利的社会经济条件与孕产妇死亡联系起来。 10与循环炎症生物标志物、慢性胎盘炎症和不良反应有关的心理社会功能 11妊娠结局GPNC可能通过降低全身和胎盘炎症活性来减少PTB 12通过改善处于社会不利地位的妇女的社会心理功能。在试点研究中，我们 13发现证据表明GPNC改善胎盘炎性病变的社会经济差异 虽然这些结果很有希望，但需要在更大的群体中复制这些结果， 15为了确定GPNC影响的心理，行为和生物机制 16母体-胎儿界面的炎症活动，利用胎盘基因表达来评估替代的 17种生物学途径，并阐明这些变化对减少PTB差异的影响。 18在此，我们建议利用南卡罗来纳州格林维尔的一项现有试验来解决这些问题 19（1 R 01 HD 082311）将招募3160名主要来自低收入人群的女性。母研究 20采用随机对照试验设计比较GPNC与传统产前护理， 21例患者有足够的把握度检测干预和人种的PTB差异。母研究将收集和 22分析行为和心理社会结果的调查措施，但它没有资源， 23收集生物标志物或评估生物作用机制。本提案的目的是增加生物样本 24收集到现有的试验，以了解是否GPNC，通过改善心理和行为 25功能，影响妊娠期间的炎症环境。将从1150名妇女中收集标本 26和对900个随机子集进行的全面分析，目的是（1）量化系统性 27种炎症生物标志物、胎盘组织学炎症和女性之间的胎盘基因表达 28名参与GPNC和那些接受常规产前护理的人，（2）确定这些差异是否 29例通过改善心理社会功能和/或生活方式特征介导。最终，我们的目标是 了解GPNC降低PTB频率的生物学机制。