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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Ilana Hull
Study ID
NCT05942313
Status
Recruiting
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Conditions

  • Opioid Use Disorder
  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Buprenorphine/ Methadone exposure — DRUG
    Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.

Study Details

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.

Key Dates

Start date
Aug 28, 2023
Status verified
Jul 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Pregnant women with Opioid Use Disorder (OUD)
    This study will enroll 100 pregnant women with OUD at UPMC with its high volumes

Primary Outcome Measure

Incidence of maternal opioid relapse [ Time Frame: Measured from enrollment to 3-months post delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Magee-Womens HospitalPittsburghPennsylvania15213
Ilana Hull, MD
[email protected]
Carly Riedmann, MPH
[email protected]
412-623-4147

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By research site
UPMC Magee-Womens Hospital· Pittsburgh, PA

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