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

NCT05942313 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Buprenorphine/ Methadone exposure

Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • OpalGenix, Inc

    collaborator INDUSTRY

  • Ilana Hull

    lead OTHER

Principal Investigators

  • Ilana Hull, MD · Univrsity of Pittsburgh / UPMC Magee Womens Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-28
Primary Completion
2026-12-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05942313 on ClinicalTrials.gov