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NCT03833245

Optimizing Pregnancy and Treatment Interventions for Moms 2.0

Completed NA Results posted Last updated 3 February 2025
What this trial tests

NA trial testing Patient Navigation in Pregnancy, High Risk in 102 participants. Completed in 1 October 2022.

Timeline
11 March 2019
Primary endpoint
1 October 2022
1 October 2022

Quick facts

Lead sponsorUniversity of Utah
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment102
Start date11 March 2019
Primary completion1 October 2022
Estimated completion1 October 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Utah

Who can join

18 and older, female only, with Pregnancy, High Risk or Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention Primary · 6 months

Percentage of days of days of attending outpatient and inpatient Substance Use Disorder treatment.

GroupValue95% CI
Control-1.5± 50.2
Patient Navigation-8.8± 46.7
Adherence to Medication-Assisted Treatment (MAT) Medication Use Section Primary · 6 months

Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section defined by percentage days of attendance.

GroupValue95% CI
Control30.7± 43.8
Patient Navigation40.4± 53.6
Adequacy of Prenatal Care Secondary · 1 week

Capturing prenatal care will be accessed through the adequacy of prenatal care utilization index (APNCU). This index will be used to determine the sufficiency of prenatal care participants received.

GroupValue95% CI
Control10
Patient Navigation12
Control13
Patient Navigation15
Control11
Patient Navigation11
Control9
Patient Navigation11

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mindfulness and Savoring: A Commentary on Savoring Strategies and Their Implications for Addiction Treatment.
    Bryan MA, Mallik D, Cochran G, Lundahl B. · · 2022 · cited 14× · PMID 35349380 · DOI 10.1080/10826084.2022.2046090
  2. A pilot multisite study of patient navigation for pregnant women with opioid use disorder.
    Cochran G, Smid MC, Krans EE, Bryan MA, et al · · 2019 · cited 13× · PMID 31731006 · DOI 10.1016/j.cct.2019.105888
  3. Pregnancy and the Opioid Crisis: Heightened Effects of COVID-19.
    White A, Lundahl B, Bryan MA, Okifuji A, et al · · 2022 · cited 9× · PMID 34282083 · DOI 10.1097/adm.0000000000000822
  4. Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial.
    Cochran G, Smid MC, Krans EE, Yu Z, et al · · 2024 · cited 8× · PMID 37859587 · DOI 10.1111/add.16364
  5. Prospective acceptability of digital phenotyping among pregnant and parenting people with opioid use disorder: A multisite qualitative study.
    Charron E, White A, Carlston K, Abdullah W, et al · · 2023 · cited 7× · PMID 37139320 · DOI 10.3389/fpsyt.2023.1137071
  6. Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy.
    Minozzi S, Ambrosi L, Saulle R, Uhm SS, et al · · 2024 · cited 6× · PMID 38682758 · DOI 10.1002/14651858.cd015042.pub2
  7. Nonfatal Overdoses Among Pregnant Individuals With Opioid Use Disorder.
    Charles JE, Baylis J, Smid MC, Cochran G. · · 2023 · cited 3× · PMID 37103536 · DOI 10.1097/aog.0000000000005129

Verify or expand the search:

Other trials of Patient Navigation

Trials testing the same drug.

Other recruiting trials for Pregnancy, High Risk

Currently open trials in the same condition.

Other University of Utah trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03833245.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing