NCT06941974: PATH

Partnering With Antenatal Navigators to Transform Health in Pregnancy

Recruiting now NA Last updated 6 April 2026

What this trial tests

NA trial testing Patient Navigation Program in Maternal Morbidity in 600 participants. Currently enrolling.

Timeline

6 October 2025

Primary endpoint
1 December 2029

1 June 2030

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	600
Start date	6 October 2025
Primary completion	1 December 2029
Estimated completion	1 June 2030
Sites	1 location across United States

Drugs / interventions tested

• Patient Navigation Program

Conditions studied

• Maternal Morbidity — all drugs for Maternal Morbidity →
• Antenatal Health — all drugs for Antenatal Health →
• Neonatal Morbidity — all drugs for Neonatal Morbidity →
• Retention in Care — all drugs for Retention in Care →

Sponsor

Northwestern University

Who can join

Adults 16 to 50, female only, with Maternal Morbidity or Antenatal Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.