RecruitingNot Applicable

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

United States600 participantsStarted 2018-09-15

Plain-language summary

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).

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of opioid misuse severity using assessments

Timeframe: 5 years

Pharmacological treatment for neonatal abstinence syndrome

Timeframe: 5 years

Trial details

NCT IDNCT03923374

SponsorSenthil Sadhasivam

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-30

Contact for this trial

Senthil Sadhasivam, MD, MPH

4126474484 sadhasivams@upmc.edu

View on ClinicalTrials.gov More Opioid-use Disorder trials