NCT03923374 Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
| NCT ID | NCT03923374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Senthil Sadhasivam |
| Condition | Opioid-use Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2018-09-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2018-09-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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.
Contact & Investigator
Senthil Sadhasivam, MD, MPH
PRINCIPAL INVESTIGATOR
University of Pittsburgh, UPMC
Frequently Asked Questions
Who can join the NCT03923374 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Opioid-use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03923374 currently recruiting?
Yes, NCT03923374 is actively recruiting participants. Contact the research team at sadhasivams@upmc.edu for enrollment information.
Where is the NCT03923374 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT03923374 clinical trial?
NCT03923374 is sponsored by Senthil Sadhasivam. The principal investigator is Senthil Sadhasivam, MD, MPH at University of Pittsburgh, UPMC. The trial plans to enroll 600 participants.