ClinConnect ClinConnect Logo
Search / Trial NCT03923374

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

Pregnant With Opioid Use Disorder Opioid Use Disorder ( Oud) Subutex Buprenorphine Pregnant Taking Buprenorphine/Subutex

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.

Locations

Indianapolis, Indiana, United States

Pittsburgh, Pennsylvania, United States

Patients applied

0 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

Similar Trials