RecruitingNot Applicable

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

United States100 participantsStarted 2023-08-28

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of maternal opioid relapse

Timeframe: Measured from enrollment to 3-months post delivery

Incidence of NOWS

Timeframe: Measured at delivery

Trial details

NCT IDNCT05942313

SponsorIlana Hull

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-01

Contact for this trial

Amy Monroe, MPH, MBA

412-623-6382 monroeal@upmc.edu

View on ClinicalTrials.gov More Opioid Use Disorder trials