Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
Study Details
Study Description
Brief Summary
This study will be a 21-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 240 pregnant women with OUD at UPMC 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pregnant women with Opioid Use Disorder (OUD) This study will enroll 240 pregnant women with OUD at UPMC with its high volumes |
Drug: Buprenorphine/ Methadone exposure
Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of maternal opioid relapse [Measured from enrollment to 3-months post delivery]
Measured via binary response, yes/no
- Incidence of NOWS [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 Outcome Measures
- Severity of Maternal Opioid Relapse [Measured from enrollment to 3-months post delivery]
Severity of maternal opioid relapse measured by requirement of medical treatment (binary response, yes/no)
- Severity of NOWs [Measured at delivery]
Severity of NOWs measured by the need for >3 days of hospital stay (binary response, yes/no)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnant women with OUD and their infant
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Currently on BUP/METH for OUD
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Enrolled in prenatal opioid maintenance program
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Age >18 years
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Singleton pregnancy
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Planned delivery at UPMC's Magee Womans Hospital
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Positive opioid urine screen results
Exclusion Criteria:
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Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
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HIV or AIDS
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Known major fetal congenital abnormalities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC Magee-Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Elizabeth Krans, MD
- National Institute on Drug Abuse (NIDA)
- OpalGenix, Inc
Investigators
- Principal Investigator: Elizabeth Krans, MD, MSc, Univrsity of Pittsburgh / UPMC Magee Womens Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY23010043
- 1R43DA058430-01