Predicting and preventing adverse outcomes of opioid use disorder in pregnant women
Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05942313 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with serious maternal medical illnesses, HIV/AIDS, or known major fetal congenital abnormalities may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.