Actively Recruiting
Partnering With Antenatal Navigators to Transform Health in Pregnancy
Led by Northwestern University · Updated on 2026-04-06
600
Participants Needed
1
Research Sites
26 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
Researchers are evaluating whether an antenatal patient navigation program called PATH can improve health outcomes for low-income pregnant women and their babies. This randomized controlled trial focuses on first-time pregnant women with low income, aiming to reduce adverse maternal and neonatal outcomes by addressing barriers to care and enhancing healthcare access and engagement. The study also explores patient, clinician, navigator, and healthcare system experiences to support future implementation of this program. The study compares two groups: one receiving the PATH patient navigation program and the other receiving usual antenatal care. PATH navigators provide individualized support from early pregnancy (before 20 weeks of gestation) through two weeks postpartum. Services include education, appointment coordination, communication with clinical teams, transportation assistance, mental health support, and addressing non-medical needs. Participants are followed through five study visits from enrollment to nine months postpartum. Participants will complete surveys, interviews, and medical record reviews at set intervals during pregnancy and postpartum to assess health outcomes and experiences. Researchers measure a composite of maternal adverse outcomes and neonatal adverse outcomes, healthcare utilization, patient-reported health status, quality of life, stress, self-efficacy, and satisfaction with care. The study monitors outcomes from enrollment through delivery and up to nine months after birth, aiming to understand the effectiveness and feasibility of PATH navigation for low-income pregnant women.
CONDITIONS
Brief Title
Partnering With Antenatal Navigators to Transform Health in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy less than 20 weeks gestation
- First pregnancy with no previous pregnancies at or beyond 20 weeks, excluding terminations
- Low income defined by public insurance or living in a low-income neighborhood
- Ability to speak and read English or Spanish
- Established patient at a Northwestern Medical Group practice
- Age 16 years or older and up to 50 years old
You will not qualify if you...
- Planning to transfer care to a different healthcare institution
- Previously enrolled in the PATH program
- Currently enrolled in another study with competing goals or interventions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 20 weeks of gestation before enrollment
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - From enrollment (less than 20 weeks gestation) through delivery hospitalization, on average 28 weeks
Participants randomized to the navigation group receive individualized antenatal patient navigation services tailored to support health and access to care throughout pregnancy. Participants in the usual care group receive standard antenatal care without navigation.
3 visits during pregnancy: before 20 weeks, 28-32 weeks, and at delivery hospitalization
Duration - From delivery hospitalization through 9 months postpartum
Participants continue in study follow-up including surveys, interviews, and medical record reviews to assess health outcomes and experiences up to 9 months after delivery.
2 visits postpartum: 6-12 weeks and 9 months postpartum
Trial Site Locations
Total: 1 location
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
L
Lynn M Yee, MD, MPH
B
Brittney R Williams, MPH
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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