A ‘Standard of Care PLUS’ Model for Preterm Birth Prevention: Integrating Nutrient and Gene Variant Analysis with Targeted Interventions

Abstract Purpose: High rates of adverse maternal and neonatal outcomes, such as preterm birth (PTB), hypertensive disorders of pregnancy (HDP), gestational diabetes mellitus (GDM), small for gestational age (SGA), and large for gestational age (LGA) persist in the US, highlighting the need for prevention and effective interventions beyond the current standard of care (SOC) particularly in diverse, socio-economically challenged populations. Objective: A prospective observational study evaluated a targeted diet and lifestyle intervention incorporating select nutrient and gene variant analysis and personalized trimester-based nutrition counseling and supplementation in collaboration with in-person standard of care (PLUS) compared to standard of care alone (SOC) in reducing adverse outcomes. The impact of mode of PLUS delivery was also evaluated: individual-virtual vs in-person group. Results: This study compared a Nevada PLUS cohort (N=15): high-risk participants, all covered by Medicaid, who received the PLUS intervention virtually and an Oregon PLUS cohort (N=387): moderate-risk participants with 50% Medicaid coverage who received the PLUS intervention through in-person group sessions, against each other and against regional SOC outcomes. The Nevada PLUS data showed non-significant reductions across all measured adverse outcomes because of small sample size. The Oregon PLUS showed highly significant risk reductions in all outcomes (p-value < .001). When comparing the outcomes of the Nevada (virtual) and Oregon (in-person) PLUS cohorts directly, no statistically significant differences were found based on how the PLUS model was delivered. Given no significant difference by delivery mode, the two PLUS cohorts were combined (pooled N=402). This pooled group revealed highly significant risk reductions in all outcomes (p -value < .001): PTB (RR = .229), HDP (RR .114), GDM (RR .057), SGA (RR .246), and LGA (RR .347) compared to regional SOC outcomes. Conclusion: These findings suggest that implementing select nutrient and gene variant analysis with targeted nutritional and lifestyle interventions in collaboration with in-person standard of care is associated with significant reductions in the incidence of key adverse maternal and neonatal outcomes in diverse pregnant populations, and that an individual-virtual mode of PLUS delivery appears as effective as an in-person group mode.