Actively Recruiting

Phase Not Applicable
Age: 16Years - 50Years
FEMALE
NCT06941974

Partnering With Antenatal Navigators to Transform Health in Pregnancy

Led by Northwestern University · Updated on 2026-04-06

600

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Partnering With Antenatal Navigators to Transform Health in Pregnancy

Who Can Participate

Age: 16Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Singleton pregnancy less than 20 weeks gestation
  • First pregnancy with no prior pregnancy of 20 weeks or more
  • Low income (public insurance or living in an area where over 10% of households earn below 125% of the federal poverty level)
  • Ability to speak and read English or Spanish
  • Established patient at a Northwestern Medical Group practice
  • Age 16 years or older
Not Eligible

You will not qualify if you...

  • Plans to transfer care to another institution
  • Previous participation in the PATH program
  • Currently enrolled in another study with competing goals or interventions

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Trial Site Locations

Total: 1 location

1

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

L

Lynn M Yee, MD, MPH

CONTACT

B

Brittney R Williams, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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