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NCT04251208 · ClinicalTrials.gov registry record
MOms in REcovery (MORE) Study: Defining Optimal Care
A clinical trial, sponsored by Trustees of Dartmouth College.
- Completed
- Registry status
- 444
- Enrollment target
NCT04251208: Completed study, sponsored by Trustees of Dartmouth College.
NCT04251208 is a clinical trial that has completed, run by Trustees of Dartmouth College. The registered enrollment target is 444 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04251208 has completed, sponsored by Trustees of Dartmouth College.
- COMPLETED
- Registry status
- 444 participants
- Enrollment target
Study Summary
Northern New England has among the highest rates of opioid dependence in the U.S, with prevalence highest and growing among those of between the ages of 18-35 years. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with opioid use disorder. In northern New England (Maine, New Hampshire, \& Vermont), 5-8% of newborns have mothers with an opioid use disorder (OUD), greatly increasing the risk of poor outcomes, including preterm birth and long hospitalization for neonatal withdrawal and other newborn complications. For pregnant women with OUD, medication assisted treatment (MAT) significantly reduces these risks. However, it is sometimes difficult for pregnant women to find MAT providers. As a result, many maternity care providers have begun to prescribe MAT in their own practices. Other practices have maintained the longstanding evidence-based standard of care, referral of patients with OUD to specialty MAT treatment program. Most pregnant women with OUD have other psychosocial needs, ranging from lack of housing and untreated mental health conditions, to need for parenting education and support. There is variability among practices in terms of types of other services provided to patients, whether the practice has integrated MAT or relies on referral. Although pregnancy is a time when women are highly motivated to start MAT, many women are also likely to discontinue MAT postpartum due to loss of insurance coverage, difficulty transitioning to another provider, loss of motivation for treatment, or competing demands on time and resources as a new parent. The challenge for patients, providers, and other stakeholders is to understand the relative advantage of the two MAT models (receiving MAT as part of maternity care or at a specialty program) for improving key outcomes for baby \& mother. A second challenge is to understand the relative contributions of onsite services such as ment
Primary Outcome
Each clinical record describes the care of the patient over the course of her pregnancy. Urine opioid toxicology results will be reviewed in laboratory reports from each of three time periods. Data collection will include the presence/absence of nonprescribed opioids or metabolites during that time period and measure tracks the change in illicit opioid use across three time periods. Time periods include: third trimester (between 28-36 weeks of pregnancy); delivery episode (between 36-41 weeks of
Interventions
- OTHER Observational Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2024-01-31 |
What the finished NCT04251208 record still lists
NCT04251208 is an observational study that tracks outcomes without assigning an intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Observational Study is the first listed.
NCT04251208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04251208 about?
NCT04251208 is a clinical study titled "MOms in REcovery (MORE) Study: Defining Optimal Care". Northern New England has among the highest rates of opioid dependence in the U.S, with prevalence highest and growing among those of between the ages of 18-35 years. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant wo...
What is the current status of trial NCT04251208?
This trial is currently completed. The enrollment target is 444 participants. The study started on 2019-07-30. Estimated completion is 2024-01-31.
What interventions are being tested in trial NCT04251208?
The interventions under investigation include: Observational Study (OTHER).
Who is sponsoring clinical trial NCT04251208?
This trial is sponsored by Trustees of Dartmouth College, which has 31 total clinical trials registered on ClinicalTrials.gov.
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