Partnering With Antenatal Navigators to Transform Health in Pregnancy

Recruiting now · Not applicable

Conditions studied: Maternal Morbidity, Antenatal Health, Neonatal Morbidity, Retention in Care, Prenatal Care

In brief

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.

Key facts

Study ID

NCT06941974

Run by

Northwestern University

People needed

600

Starts

2025-10-06

Expected to finish

2030-06-01

Last updated by the study team

2026-04-06

Who can join

Age: 16 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Singleton gestation <20 weeks of gestation
• Nulliparous: no prior pregnancies ≥20 weeks excluding terminations
• Low income (public insurance or residence in a neighborhood in which >10% of household incomes are <125% of federal poverty line
• Ability to speak and read English or Spanish
• Established patient at one of practices associated with Northwestern Medical Group
• Age 16 years or older
• Exclusion:
• Intent to transfer care to an outside institution
• Prior enrollment in PATH
• Concurrent enrollment in a study with competing aims/intervention

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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