Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSenthil Sadhasivam
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Serious maternal medical illness as deemed by study physician or investigator.
Known or suspected major fetal/neonatal congenital abnormalities.
Trial design
Treatments tested in this trial
- Subutex / Buprenorphine
- Fetal & Neonatal MRI
- DNA/Genetic/Pharmacokenetic Blood Draws
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Senthil Sadhasivam
Lead sponsor
University of Pittsburgh
Sponsor institution
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov