CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 102 enrolled
Drug / intervention
Patient Navigationbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03833245
NCT03833245N/ACompleted

Optimizing Pregnancy and Treatment Interventions for Moms 2.0

University of Utah·interventional·Posted Feb 6, 2019·Updated Feb 3, 2025

In Brief

A clinical study evaluating Patient Navigation for Pregnancy, High Risk and 2 related conditions. Completed, enrolled 102 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 6, 2019
Enrollment StartMar 11, 2019
Primary CompletionOct 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.4 years ago

Interventions

Patient Navigationbehavioral

The patient navigation (PN) intervention will initiate following participant recruitment. It is important to note that PN sessions do not strictly coincide with specific weeks of pregnancy since the women can be recruited up to ≤25 weeks of gestation. The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention. All contact will be reported by staff in a patient contact log developed for the study that will be used to quantify level of patient contact.