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Personalized care for prenatal stress reduction and preterm birth prevention

$651,209R01FY2025MDNIH

Univ Of North Carolina Chapel Hill, Chapel Hill NC

Investigators

Linked publications, trials & patents

Abstract

ABSTRACT This project addresses the critical barrier of solutions for preterm birth (PTB) by deploying a novel, personalized, comprehensive 3-tier PTB prevention program (UNC PTBCARE+) to reduce perinatal stress. Significant PTB disparities exist; pregnant individuals from racially diverse backgrounds have a 49% higher likelihood of delivering preterm, often at earlier gestational ages, and report higher levels of stress and higher allostatic loads compared to other populations. Our long-term goal is to refine and widely deploy an evidence-based intervention, UNC PTBCARE+, to mitigate stress during pregnancy and reduce PTB. Our 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 social support (Tier 2a level support, for those who screen positive), financial support (Tier 2b level support, for those who screen positive), or both (Tier 3 level support) is associated with stress reduction (assessed by validated surveys and by biomarkers), and PTB <35 weeks. Further, we will examine which interventions are most helpful and if results vary by population. 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 underrepresented populations by addressing stress linked to contextual social factors, and that biologic analyses will provide key objective insight into the mechanisms underlying stress-related PTB and the intervention’s impact. 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, experiences of racial discrimination), (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 at UNC. 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. By delivering actionable, personalized approaches, this study addresses the critical issue of PTB. It holds substantial promise for generating scalable, low-risk solutions to mitigate PTB and its disproportionate impact across populations.

View original record on NIH RePORTER →