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Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

Who can join

Ages 18 and older · Women · Healthy volunteers welcome

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.

About the study

The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).

What is being tested

• Subutex / Buprenorphine (drug)
• Fetal & Neonatal MRI (diagnostic test)
• DNA/Genetic/Pharmacokenetic Blood Draws (diagnostic test)

Sponsor: Senthil Sadhasivam · Participants: 600 · Started: Sep 15, 2018

Contact the study team

• Senthil Sadhasivam, MD, MPH · Phone: 4126474484
• Carly Riedmann, MPH · Phone: 4126234147

Official record on ClinicalTrials.gov — NCT03923374

Locations in the U.S.

Conditions

• Opioid Overdose

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.