Recruiting

Antenatal Navigation

Sponsor:

Northwestern University

Code:

NCT06941974

Conditions

Maternal Morbidity

Antenatal Health

Neonatal Morbidity

Retention in Care

Prenatal Care

Eligibility Criteria

Sex: Female

Age: 16 - 50

Healthy Volunteers: Not accepted

Interventions

Patient Navigation Program

Study Details

Brief summary:

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

Maternal Morbidity

Antenatal Health

Neonatal Morbidity

Retention in Care

Prenatal Care

Study ID

NCT06941974

Start date

Oct 6, 2025

Status verified date

Apr, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Navigation Group

Pregnant participants who are randomized to receive PATH patient navigation will be assigned to a patient navigator. The patient navigator will meet with the patient in early pregnancy for introductions, education, and assessing factors that influence health and access to care. The patient navigator will offer support and resources (e.g., appointment coordination and scheduling, communication with clinical team, transportation, community referrals, support for mental health, support for other non-medical needs, etc.). The navigator will provide support and continue linkage to resources through 2 weeks postpartum.

no intervention: Non-navigation Group

No navigation will be provided; pregnant participants will receive usual care.

Interventions

Patient Navigation Program

PATH navigation is an antenatal patient navigator program designed to reduce barriers to care, enhance access, improve self-efficacy and knowledge, and improve multiple perinatal health outcomes. PATH navigation is a flexible, multi-pronged, patient-centered program with the capacity to evolve with patient needs and preferences. Early in pregnancy, navigators will establish themselves as a non-medical resource and will introduce PATH as a program designed to help inform, support, and connect patients during pregnancy. Navigators will review screen and address supportive and adverse non-medical needs, facilitate communication, perform logistical support, provide advocacy and bridge communication with clinical teams, and perform health education. Navigation services will be tailored to individual medical, psychosocial, or logistical complexity.

Primary outcome measure

  • Maternal adverse outcome composite (Aim 1 primary outcome) [ Time Frame: Enrollment through delivery hospitalization, an average of 28 weeks ]
  • Neonatal adverse outcome composite (Aim 2 primary outcome) [ Time Frame: At birth/delivery ]

Central Contacts and Locations

Central contacts

Lynn M Yee, MD, MPH

312-472-0119lynn.yee@northwestern.edu

Brittney R Williams, MPH

brittney.williams@northwestern.edu

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Brittney R Williams, MPH

312-503-3476brittney.williams@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-04-06.