Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Buprenorphine/ Methadone exposure.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, Pregnancy Related. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Buprenorphine/ Methadone exposure
Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.
Primary outcome measures
- Incidence of maternal opioid relapse [Time frame: Measured from enrollment to 3-months post delivery]
- Incidence of NOWS [Time frame: Measured at delivery]
Secondary outcome measures (2)
- Severity of Maternal Opioid Relapse [Time frame: Measured from enrollment to 3-months post delivery]
- Severity of NOWs [Time frame: Measured at delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UPMC Magee-Womens Hospital — Pittsburgh
Identifiers
NCT: NCT05942313 · STUDY23010043 · 1R43DA058430-01