IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk.

Abstract

Preterm birth is a major cause of neonatal morbidity and mortality rate. Non-Hispanic black patients disproportionately experience preterm birth and nonadherence to evidence-based preventive measures. Interventions tailored to non-Hispanic black birthing individuals (NHBBIs) that address barriers to preterm birth preventions are urgently needed. Together with a community-engaged multidisciplinary stakeholder group, we developed an intervention to improve adherence to preterm birth preventions among black pregnant patients with prior preterm birth. The intervention included the following: (1) preterm birth prevention education, (2) an employment navigation toolkit, and (3) encouragement text messages. We piloted the intervention by recruiting self-identified non-Hispanic black patients at or before 20 weeks of gestation with a prior preterm birth and randomizing them to the intervention or an active control. The primary outcomes were feasibility and acceptability. Our secondary outcomes were preliminary efficacy based on birth outcomes, patient experience, and pregnancy-specific anxiety (PSA). Descriptive statistics, analysis of verbatim survey responses, Wilcoxon signed rank, and Fisher's exact were used to describe and compare quantitative and qualitative data. We identified 53 individuals who met the inclusion criteria, 35 were reachable remotely and 30 were enrolled and randomized. More than 80% (n=26) were retained throughout the study, and 100% of participants identified at least one intervention component as helpful. In this small pilot, there were no detectable differences in adherence to preterm birth preventive recommendations. No difference in preterm births, other pregnancy, or patient experience outcomes was detected between the intervention and active control participants. The intervention is feasible and acceptable. Larger, appropriately powered studies are needed to assess whether the intervention will decrease PSA and reduce preterm birth. This trial was registered with ClinicalTrials.gov (NCT04933812).