N/A
N=102
Optimizing Pregnancy and Treatment Interventions for Moms 2.0
Pregnancy, High Risk · Opioid-Related Disorders · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT03833245 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention — -1.5; -8.8 Percentage of days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Navigation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Utah
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention |
-1.5; -8.8 | — |
| PRIMARY Adherence to Medication-Assisted Treatment (MAT) Medication Use Section |
30.7; 40.4 | — |
| SECONDARY Adequacy of Prenatal Care |
10; 12; 13; 15; 11; 11 | — |
Summary
The US opioid epidemic continues to result in serious health consequences for pregnant and postpartum women. In the US from 2007 to 2012, an average of 21,000 pregnant women each year reported past month opioid misuse. This study aims to provide rapid and targeted primary prevention activities aimed at assisting pregnant women with opioid use disorder (OUD) to become linked to and retained in treatment in order to reduce harms to them (including overdose) and their offspring.
Eligibility Criteria
Inclusion Criteria
- Adult (≥18 years)
- English speaking
- Pregnant women (pregnancy status verified by gestational age >6 weeks from last menstrual period confirmed by ultrasound)
- OUD verified by examination of medical records for an OUD diagnosis, urine toxicology, and the Diagnostic and Statistical Manual of Mental Disorders (DSM) Checklist (modified from the DSM-IV to confirm current diagnosis for substance use disorders)
- Plan to carry their babies to delivery verified by patient self report
Participant Exclusion Criteria
- Experienced a psychotic or a manic episode in the last 30 days documented in their medical record
- Beyond the 25th week of gestation
- Cannot provide collateral contact information of 2 persons,
- Cannot provide a reliable phone number,
- Plan to move from the area within 2 months of their delivery will or 6 months after not be included in the study
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
- Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study
Data sourced from ClinicalTrials.gov (NCT03833245). 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.