N/A
N=269
The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03725332 ↗Enrolled (actual)
269
Serious AEs
24.8%
Results posted
May 2025
Primary outcome: Primary: Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment — 24.1; 33.3 % infants requiring medication for NAS
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telemedicine (Behavioral); Group Care (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wendy F Hansen
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment |
24.1; 33.3 | — |
| SECONDARY Number of Inappropriate Maternal Drug Screens at Delivery |
12; 29 | — |
| SECONDARY Prenatal Engagement With Percent of Program Education Sessions Attended |
12; 36; 26; 62; 41; 77 | — |
| SECONDARY Prenatal Engagement With MAT Provider |
12.0; 8.40 | — |
| SECONDARY Prenatal Engagement in Prenatal Care |
4; 11; 16; 35; 59; 129 | — |
| SECONDARY Participants With Cigarette Dependency Over Time |
14; 42; 7; 20; 15; 28 | — |
| SECONDARY Participants With Maternal Anxiety Over Time |
7; 23; 16; 50; 43; 78 | — |
| SECONDARY Participants With Maternal Depression Over Time |
24; 60; 8; 19; 46; 88 | — |
| SECONDARY Participant Quality of Life |
18; 29; 26; 55; 2; 6 | — |
| SECONDARY Severity of Opioid Use Disorder |
41; 65; 8; 25; 7; 15 | — |
| SECONDARY Incidence of Hospitalization for Opioid Related Issues During the Study Period |
2; 4 | — |
| SECONDARY Change in Physical Condition of Infant Post-delivery by Apgar Score |
7.89; 7.94; 8.61; 8.76 | — |
| SECONDARY Incidence of Pediatric Emergency Room (ER) Visits |
10; 11 | — |
| SECONDARY Adherence to a Vaccine Schedule |
27; 45; 22; 39 | — |
| SECONDARY Engagement With Pediatric Care |
30; 49; 26; 42 | — |
| SECONDARY Infant Gross Motor Development |
50.40; 48.71 | — |
| SECONDARY Infant Gross Motor Development |
50.40; 48.71 | — |
| SECONDARY Incidence of Relapse |
10; 29; 37; 188 | — |
| SECONDARY Incidence of Opioid Overdose |
0; 4 | — |
Summary
Perinatal opioid use disorder (OUD) is a major health concern in the U.S. with significant impact on mothers, infants, and communities. Investigators at the University of Kentucky/UK HealthCare (UK) have developed a comprehensive clinical care model for perinatal OUD (known as UK-PATHways) that has demonstrated success in maternal and neonatal outcomes. The overreaching goals of the proposed project are to: 1) expand the reach of this successful clinical program to rural communities thereby improving access to integrated MAT prenatal care, 2) to reduce the impact of perinatal OUD in underserved rural areas of our state, and 3) to compare the relative effectiveness methods of delivery active elements of the UK-PATHways program for rural implementation (local group-support vs. telemedicine).
Eligibility Criteria
Inclusion Criteria
- Pregnant women at 6 to 32 weeks' gestational age
- History of Opioid Use Disorder
- Receiving Medication Assisted Therapy (buprenorphine products or methadone)
- Obtaining prenatal care at one of eleven study sites located throughout Central and Eastern Kentucky
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT03725332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.