← Back to Clinical Trials
Recruiting NCT05942313

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

Trial Parameters

Condition Opioid Use Disorder
Sponsor Ilana Hull
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2023-08-28
Completion 2026-12-01
Interventions
Buprenorphine/ Methadone exposure

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.

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

Related Trials