Predicting and preventing adverse outcomes of opioid use disorder in pregnant women
Official title: Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
Run by University of Pittsburgh · NCT05942313 · Data updated 2026-11-12
This study is trying to see how genetic factors affect the health of pregnant women with opioid use disorder and their babies while they are being treated with medication.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | August 28, 2023 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT05942313 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women over 18 years old with opioid use disorder who are currently on medication management and plan to deliver at UPMC Magee-Womens Hospital.
✕Probably not a fit
Patients with serious maternal medical illnesses, HIV/AIDS, or known major fetal congenital abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to enroll 100 pregnant women with opioid use disorder (OUD) who are currently receiving treatment with buprenorphine or methadone. Over a 12-month period, the study will collect longitudinal data to assess the impact of genetic factors on maternal and infant outcomes related to opioid use during pregnancy. The research will focus on understanding the relationship between genetic variations and the effectiveness of medication management, as well as the associated risks of neonatal opioid withdrawal syndrome and long-term developmental issues. The study will be conducted at UPMC Magee-Womens Hospital in Pittsburgh, Pennsylvania.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for pregnant women with OUD, ultimately enhancing maternal and infant health outcomes.
How similar studies have gone: While the study addresses a significant public health issue, the specific approach of integrating genetic factors into the management of OUD in pregnancy is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Ilana Hull, MD — Univrsity of Pittsburgh / UPMC Magee Womens Hospital
- Study coordinator: Amy Monroe, MPH, MBA
- Email: monroeal@upmc.edu
- Phone: 412-623-6382
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.