Understanding Opioid Use Disorder in Pregnant Women and Its Effects on Infants
Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
This study looks at how opioid use during pregnancy affects mothers and their babies, trying to see if certain factors can help identify women who might not respond well to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT03923374 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the integration of clinical and genetic factors to identify pregnant women with opioid use disorder (OUD) who may be at risk for poor treatment responses and to assess the potential impact on their infants. The study will involve MRI scans, blood draws, and various assessments during pregnancy and follow-up for up to two years after birth. It plans to enroll 200 mothers with OUD and 100 mothers without a history of opioid use to compare outcomes. The research will focus on the effects of in-utero buprenorphine (Subutex) on both mothers and their infants.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old who are currently taking buprenorphine for opioid use disorder and are enrolled in a prenatal opioid maintenance program.
Not a fit: Patients with serious maternal medical illnesses or known major fetal/neonatal congenital abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for pregnant women with opioid use disorder and better health outcomes for their infants.
How similar studies have performed: Other studies have shown success in understanding the effects of opioid use during pregnancy, but this specific approach integrating genetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater 18 years * Currently taking Buprenorphine for Opioid Use Disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at IU Health University Hospital. * Pregnant with single baby * Planned delivery at Methodist, University or Riley Hospital Exclusion Criteria: * Serious maternal medical illness as deemed by study physician or investigator. * Known or suspected major fetal/neonatal congenital abnormalities.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Children's Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Senthil Sadhasivam, MD, MPH — University of Pittsburgh, UPMC
- Study coordinator: Senthil Sadhasivam, MD, MPH
- Email: sadhasivams@upmc.edu
- Phone: 4126474484
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.