Understanding Opioid Use Disorder in Pregnant Women and Its Effects on Infants

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.