Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIlana Hull
About this trial
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
Qualifiers
Pregnant women with OUD and their infant
Currently on BUP/METH for OUD
Enrolled in prenatal opioid maintenance program
Age >18 years
Disqualifiers
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
Trial design
Treatments tested in this trial
- Buprenorphine/ Methadone exposure
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Ilana Hull
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
OpalGenix, Inc
Collaborator
Source ClinicalTrials.gov