Antenatal navigator support to improve pregnancy and newborn health
Partnering With Antenatal Navigators to Transform Health in Pregnancy
This trial will test whether giving low-income pregnant people a dedicated antenatal navigator from early pregnancy through two weeks after birth improves their health, their newborns' health, care experiences, and use of health services.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06941974 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares an antenatal patient navigation program to usual care among low-income, nulliparous people with a singleton pregnancy enrolled before 20 weeks' gestation. Navigators provide individualized, barrier-focused, longitudinal support from enrollment through two weeks postpartum to promote access, self-efficacy, and sustained engagement with care. The trial measures maternal morbidity, neonatal morbidity, patient-reported care experiences, and health care utilization. Participants must be English- or Spanish-speaking, age 16 or older, and established patients at Northwestern-affiliated practices in the Chicago area.
Who should consider this trial
Good fit: Ideal candidates are English- or Spanish-speaking, low-income people age 16 or older with a singleton, first pregnancy enrolled before 20 weeks who receive care at Northwestern-affiliated practices.
Not a fit: People who are multiparous, plan to transfer care outside the institution, are already enrolled in PATH or in conflicting studies, or who enroll after 20 weeks are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could reduce adverse maternal and neonatal outcomes and increase engagement with prenatal and postpartum care for low-income pregnant people.
How similar studies have performed: Prior research showed that postpartum patient navigation improved receipt of postpartum care and transition to primary care, but comprehensive antenatal navigation has not been tested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Lynn M Yee, MD, MPH — Northwestern University
- Study coordinator: Lynn M Yee, MD, MPH
- Email: lynn.yee@northwestern.edu
- Phone: 312-472-0119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.