Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Launched by SENTHIL SADHASIVAM · Apr 18, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to understand how both medical history and genetics affect pregnant women who are using buprenorphine to treat opioid use disorder. The goal is to identify which mothers might struggle with their treatment and which babies could be at higher risk for experiencing withdrawal symptoms after birth, a condition known as neonatal abstinence syndrome (NAS).
To participate in this study, women must be at least 18 years old, currently taking buprenorphine, and enrolled in a prenatal program at IU Health University Hospital. They also need to be pregnant with one baby and plan to deliver at Methodist, University, or Riley Hospital. Participants can expect to provide information about their health and possibly undergo some tests to help researchers gather important data. This study is actively recruiting participants, and understanding more about these factors could lead to better care for both mothers and their babies in the future.
Gender
FEMALE
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.
About Senthil Sadhasivam
Senthil Sadhasivam is a dedicated clinical trial sponsor with a focus on advancing medical research through innovative and rigorous study designs. Committed to improving patient outcomes, Sadhasivam leverages extensive expertise in clinical methodologies and regulatory compliance to facilitate the development of new therapies. By fostering collaborations with healthcare professionals and research institutions, he aims to contribute to the understanding of complex medical conditions and enhance treatment options available to patients. With a strong emphasis on ethical practices and patient safety, Senthil Sadhasivam is positioned as a reliable partner in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Pittsburgh, Pennsylvania, United States
Patients applied
Trial Officials
Senthil Sadhasivam, MD, MPH
Principal Investigator
University of Pittsburgh, UPMC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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