NCT06941974 Partnering With Antenatal Navigators to Transform Health in Pregnancy
| NCT ID | NCT06941974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Maternal Morbidity |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-10-06 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Lynn M Yee, MD, MPH
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT06941974 clinical trial?
This trial is open to female participants only, aged 16 Years or older, up to 50 Years, studying Maternal Morbidity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06941974 currently recruiting?
Yes, NCT06941974 is actively recruiting participants. Contact the research team at lynn.yee@northwestern.edu for enrollment information.
Where is the NCT06941974 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06941974 clinical trial?
NCT06941974 is sponsored by Northwestern University. The principal investigator is Lynn M Yee, MD, MPH at Northwestern University. The trial plans to enroll 600 participants.