Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
Ilana Hull
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.
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 depressio…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- 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
Interventions
- DrugBuprenorphine/ Methadone exposure
Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.
Location
- UPMC Magee-Womens HospitalPittsburgh, Pennsylvania