PATH Study: Patient Navigation for Pregnant Women

This study, called PATH (Partnering with Antenatal Navigators to Transform Health in Pregnancy), is testing a program where you would work with an antenatal patient navigator. This program aims to help reduce barriers to care, improve your access to healthcare, and enhance your knowledge about pregnancy. The study wants to see if this program can improve the health of both mothers and babies, as well as pregnant women's experiences with healthcare. You might be able to join if you are a woman between 16 and 50 years old, less than 20 weeks pregnant with one baby, have never had a pregnancy last 20 weeks or more (excluding terminations), have a low income, and can speak and read English or Spanish. The study will measure success by looking at maternal (mother's) and neonatal (newborn's) adverse outcomes. The current recruitment status is unclear.

Study design
This is an interventional study that plans to enroll 600 participants. It is a randomized controlled trial, meaning participants will be randomly assigned to either receive the patient navigation program or usual care.
What's involved
Navigators will support pregnant women from before 20 weeks of gestation through 2 weeks postpartum. The study will measure maternal outcomes from enrollment through delivery hospitalization (an average of 28 weeks) and neonatal outcomes at birth/delivery.
Compensation
Not stated in the trial record.
Follow-up
Maternal adverse outcomes are measured through delivery hospitalization (an average of 28 weeks). Neonatal adverse outcomes are measured at birth/delivery.

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NCT06941974

Partnering With Antenatal Navigators to Transform Health in Pregnancy

Recruiting
NAAges 16–50InterventionalSupportive care
Northwestern University
~600 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:Patient Navigation Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maternal adverse outcome composite (Aim 1 primary outcome)
Measured over Enrollment through delivery hospitalization, an average of 28 weeks
+1 more outcome measured
Maternal Morbidity
Antenatal Health
Neonatal Morbidity
Retention in Care
Prenatal Care
1 sites across 1 states
Illinois1
  • Lynn M Yee, MD, MPH · PRINCIPAL_INVESTIGATOR · Northwestern University

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Eligibility criteria

Inclusion

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
Intent to transfer care to an outside institution
Prior enrollment in PATH
Concurrent enrollment in a study with competing aims/intervention
  • Maternal adverse outcome composite (Aim 1 primary outcome)Enrollment through delivery hospitalization, an average of 28 weeks

    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).

  • Neonatal adverse outcome composite (Aim 2 primary outcome)At birth/delivery

    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).