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Clinical Trials/NCT05942313
NCT05942313RecruitingNot Applicable

Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy

Ilana Hull1 site in 1 country100 target enrollmentStarted: August 28, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Incidence of maternal opioid relapse

Study Overview

Brief Summary

This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.

Detailed Description

Background: 7% of pregnant women in the U.S. use opioids and 21% of these women report misuse, making opioid use disorder (OUD) a major public health concern during pregnancy. The number of infants born with prenatal opioid exposure, neonatal opioid withdrawal syndrome (NOWS) and costly prolonged hospitalization has increased exponentially. The opioid epidemic is further worsened by the ongoing COVID-19 pandemic. Despite medication treatment for OUD with buprenorphine (BUP) or methadone (METH), these pregnant women continue to be at high risk for early relapse, polysubstance use, and depression. These infants are at risk for not only immediate NOWS and also poor long-term neurodevelopmental and behavioral outcomes. Genetic factors influence 30-60% of opioid adverse events (AEs). In pregnant women on medication management for OUD, and infants receiving opioids for NOWS treatment there is variability in dose required to prevent withdrawal symptoms and craving, likely related to physiological alterations, upregulation of metabolic and biological pathways, determined in part by opioid pharmacogenomics. Investigators have shown that in children and adults, opioid related poor clinical outcomes are related to opioid receptor genetic variations and resulting variations in their metabolism. Maternal depression and anxiety increase the risks for OUD, maternal relapse, NOWS and negatively impact pregnant women and their children. Thus, there is an urgent and unmet clinical need for a reliable tool to proactively predict maternal relapse, NOWS, and improve the safety of pregnant women with OUD and their children.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Pregnant women with OUD and their infant
  • •Currently on BUP/METH for OUD
  • •Enrolled in prenatal opioid maintenance program
  • •Age >18 years
  • •Singleton pregnancy
  • •Planned delivery at UPMC's Magee Womans Hospital
  • •Positive opioid urine screen results

Exclusion Criteria

  • •Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
  • •HIV or AIDS
  • •Known major fetal congenital abnormalities

Arms & Interventions

Pregnant women with Opioid Use Disorder (OUD)

This study will enroll 100 pregnant women with OUD at UPMC with its high volumes

Intervention: Buprenorphine/ Methadone exposure (Drug)

Outcomes

Primary Outcomes

Incidence of maternal opioid relapse

Time Frame: Measured from enrollment to 3-months post delivery

Measured via binary response, yes/no

Incidence of NOWS

Time Frame: Measured at delivery

Clinical definition of NOWS: Substance withdrawal encompasses a continuum of variable clinical expression from neonate to neonate; the diagnosis is not limited only to neonates who require pharmacotherapy. Incidence of NOWS measured by binary response, yes/no

Secondary Outcomes

  • Severity of Maternal Opioid Relapse(Measured from enrollment to 3-months post delivery)
  • Severity of NOWs(Measured at delivery)

Investigators

Sponsor
Ilana Hull
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ilana Hull

Assistant Professor of Medicine

University of Pittsburgh

Study Sites (1)

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