Home › Opioid Overdose › NCT05942313
Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
RecruitingObservational study
Who can join
Ages 18 and older · Women
Full 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
About the study
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.
What is being tested
- Buprenorphine/ Methadone exposure (drug)
Sponsor: Ilana Hull · Participants: 100 · Started: Aug 28, 2023
Contact the study team
- Amy Monroe, MPH, MBA · Phone: 412-623-6382
- Carly Riedmann, MPH · Phone: 412-623-4147
Official record on ClinicalTrials.gov — NCT05942313
Locations in the U.S.
| Pennsylvania | UPMC Magee-Womens Hospital, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.