Partnering With Antenatal Navigators to Transform Health in Pregnancy

NCT06941974 | Recruiting

• 2 other identifiers: STU00218597R01MD020130
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Outcome Measures

Primary Outcomes (2)

• Maternal adverse outcome composite (Aim 1 primary outcome)

  Frequency of maternal composite, which includes hypertensive disorders of pregnancy, preterm birth, postpartum hemorrhage, severe maternal morbidity, or maternal mortality. Components of the primary outcome will also be examined as a score and individually as secondary outcomes (see below).

  Enrollment through delivery hospitalization, an average of 28 weeks

• Neonatal adverse outcome composite (Aim 2 primary outcome)

  Frequency of the neonatal composite, which includes neonatal intensive care unit (NICU) admission, low birthweight, small-for-gestational-age (SGA), large-for-gestational-age (LGA) status, and/or perinatal death. Components of the composite outcome will also be examined as a score and individually as secondary outcomes (see below).

  At birth/delivery

Secondary Outcomes (27)

• Hypertensive disorder of pregnancy (component of primary outcome)

  Enrollment through delivery hospitalization, an average of 28 weeks

• Preterm birth (component of primary outcome)

  Enrollment through delivery hospitalization, an average of 28 weeks

• Postpartum hemorrhage (component of primary outcome)

  At birth/delivery

• Severe maternal morbidity (component of primary outcome)

  Enrollment through delivery hospitalization, an average of 28 weeks

• Maternal mortality (component of primary outcome)

  Enrollment through delivery hospitalization, an average of 28 weeks

Other Outcomes (5)

• Participant experiences with patient navigation and antenatal care process mapping

  Enrollment through delivery hospitalization, an average of 28 weeks

• Satisfaction with navigation (interpersonal aspects)

  During pregnancy and through 9 months postpartum

• Satisfaction with navigation (logistical aspects)

  During pregnancy and through 9 months postpartum

Study Arms (2)

Navigation Group

EXPERIMENTAL

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.

Behavioral: Patient Navigation Program

Non-navigation Group

NO INTERVENTION

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

Interventions

Patient Navigation Program BEHAVIORAL

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.

Navigation Group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

You may not qualify if:

• Intent to transfer care to an outside institution
• Prior enrollment in PATH
• Concurrent enrollment in a study with competing aims/intervention

Sponsors & Collaborators

• Northwestern University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Lynn M Yee, MD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn M Yee, MD, MPH

CONTACT

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

Brittney R Williams, MPH

CONTACT

brittney.williams@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: There will be two cohorts: One cohort will be provided intensive, individualized, one-on-one navigation services from early pregnancy (before 20 weeks of gestation) through 2 weeks postpartum. The second cohort will receive usual care. Both cohorts will be followed through 9 months postpartum.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 24, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)