Partnering With Antenatal Navigators to Transform Health in Pregnancy

The Partnering with Antenatal Navigators to Transform Health in Pregnancy (PATH) study aims to evaluate whether an antenatal patient navigation program improves maternal health, neonatal health, pregnant women's experiences, and health care utilization outcomes among low-income pregnant women and their neonates. Patient navigation is an individualized, barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services. In this randomized controlled trial, pregnant women who are randomized to receive antenatal patient navigation will be compared to pregnant women who are randomized to receive usual care. Navigators will support pregnant women from before 20 weeks of gestation through 2 weeks postpartum. The PATH intervention will be grounded in understanding and addressing factors that influence health and access to care in order to promote self-efficacy, enhance access, and sustain long-term engagement. The main objectives of the study are to: 1. Evaluate whether PATH, compared to usual care, improves maternal health outcomes. We hypothesize the PATH model of antenatal patient navigation for low-income women will reduce the incidence of a composite of adverse maternal outcomes, all of which are known to be increased among women with barriers to care. 2. Evaluate whether PATH, compared to usual care, improves perinatal health outcomes. We hypothesize PATH will reduce the incidence of a composite of adverse perinatal outcomes. We will also investigate neonatal/pediatric health care utilization. 3. Evaluate patient, clinician, navigator, and healthcare system experiences with PATH in preparation for widespread implementation and dissemination of the PATH obstetric navigation model. This aim will be accomplished through investigating patient-reported outcomes, completing qualitative and process mapping interviews with navigated participants, and completing qualitative and process mapping interviews with clinicians, navigators, and health administrators.

NCT Number	NCT06941974
Lead Sponsor	Northwestern University Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Minority Health and Health Disparities (NIMHD)
Conditions	Maternal Morbidity, Antenatal Health, Neonatal Morbidity, Retention in Care, Prenatal Care
Enrollment	600 participants
Start Date	2025-10-06
Primary Completion	2029-12-01 (estimated)
Study Completion	2030-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-06