Personalized care for prenatal stress reduction and preterm birth prevention

项目摘要 该项目通过部署一个部署解决方案来解决早产（PTB）的关键障碍。 一种新颖的，个性化的，全面的三级PTB预防计划（PTBCARE+），以减少 围产期压力有显着的PTB差异;黑人怀孕患者分娩的可能性高出49% 早产，在较早的胎龄有较高的PTB风险，报告较高的感知压力， 与其他种族的患者相比，EPTBCARE+解决压力和相关机制 PTB的基础。我们的长期目标是完善和广泛部署循证干预措施， 减轻怀孕期间的压力，减少PTB。目的是在一项随机对照试验中检验， 将招募1，509名孕妇，无论我们的PTBCARE+计划是否提供特定的压力， 减少工具包和PTB护理协调员（第1层，所有患者随机分配至PTBCARE+），增强 心理社会支持（2a级支持，随机化时筛选为阳性的患者子集），经济 支持（第2b层支持，随机化时筛选为阳性的患者子集）或两者（第3层 支持）与压力减轻有关（通过有效的调查主观评估， 生物标志物），和PTB <35周。此外，我们将研究哪些干预措施最有帮助，并将 评估结果是否因种族而异。我们的中心假设是，在我们的个性化， 全面的PTB护理计划（PTBCARE+）与减轻压力，压力相关 基因表达、非稳态负荷和PTB率<35周。我们进一步假设， 由于种族主义相关的压力，将使非白人患者受益最多，生物学分析将提供关键的 客观了解压力相关PTB的机制和干预的影响。这 这一假设是基于我们的初步数据，表明：（a）处于PTB高风险的孕妇， 压力和生活压力源的高比率（例如，经济不安全、极端种族主义），（B）生物应激标记物 包括基因转录水平因孕中期血液中PTB状态而不同，（c）患者中的压力降低 在NC队列中接受专业PTB产前护理。在我们以前的工作和其他人的基础上，这个令人兴奋的 一项提案将确定PTBCARE+计划的哪些方面对压力相关的PTB最关键 还原我们通过以下目的来检验我们的假设：目的1-评价PAPTBCARE+的效果 PTB高危妊娠患者的感知压力和恢复力计划;目标2-量化程度 其中，PTBCARE+计划与妊娠期间改善的生物应激措施相关; 目的3-确定PTBCARE+计划对<35周的PTB的影响。这项研究提供 具体的，个性化的解决方案，以主要的公共卫生问题的PTB，并进行巨大的 有可能提供可推广的低风险策略，以减少PTB和PTB相关差异。

PROJECT ABSTRACT This project addresses the critical barrier of solutions for preterm birth (PTB) by deploying a deploying a novel, personalized, comprehensive 3-tier PTB prevention program (UNC PTBCARE+) to reduce perinatal stress. There are significant PTB disparities; Black pregnant patients are 49% more likely to deliver preterm, have a higher risk of PTB at earlier gestational ages, report higher perceived stress, and have higher allostatic loads compared to patients of other races. UNC PTBCARE+ addresses stress and related mechanistic underpinnings of PTB. Our long-term goal is to refine and widely deploy an evidence-based intervention to mitigate stress during pregnancy and reduce PTB. The objective is to test, in a randomized controlled trial that will enroll 1,509 pregnant patients, whether our UNC PTBCARE+ program that provides a specific stress reduction toolkit and a PTB Care Coordinator (Tier 1, all patients randomized to UNC PTBCARE+), Enhanced Psychosocial support (Tier 2a level support, subset of patients who screen positive at randomization), Financial support (Tier 2b level support, subset of patients who screen positive at randomization), or both (Tier 3 level support) is associated with stress reduction (assessed subjectively by validated surveys and objectively by biomarkers), and PTB <35 weeks. Further, we will examine which interventions are most helpful, and will evaluate whether results vary by race. Our central hypothesis is that enrollment in our personalized, comprehensive PTB care program (UNC PTBCARE+) is associated with reduced stress, stress-related gene expression, allostatic load, and rates of PTB <35 weeks. We further hypothesize that UNC PTBCARE+ will most benefit non-White patients due to racism-associated stress, and that biologic analyses will provide key objective insight into the mechanisms underlying stress-related PTB and the impact of the intervention. This hypothesis is based upon our preliminary data indicating: (a) pregnant patients at UNC at high risk for PTB have high rates of stress and life stressors (e.g., financial insecurity, extreme racism), (b) biologic stress markers including gene transcript levels differ by PTB status in mid-pregnancy blood, (c) reduced stress among patients receiving specialty PTB prenatal care in a NC cohort. Building upon our prior work and that of others, this exciting proposal will identify which aspects of the UNC PTBCARE+ program are most critical for stress-related PTB reduction. We test our hypothesis through the following aims: Aim 1- Evaluate the effects of the UNC PTBCARE+ program on perceived stress and resilience in pregnant patients at high risk for PTB; Aim 2- Quantify the extent to which the UNC PTBCARE+ program is associated with improved biologic stress measures during pregnancy; Aim 3- Determine the effects of the UNC PTBCARE+ program on PTB <35 weeks. This study provides tangible, personalized solutions to the major public health problem of PTB and carries enormous potential to provide generalizable, low-risk strategies to reduce PTB and PTB related disparities.