RecruitingNCT03923374

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

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


Sponsor

Senthil Sadhasivam

Enrollment

600 participants

Start Date

Sep 15, 2018

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial, titled "Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes" (study ID: NCT03923374), is following pregnant women who are being treated for opioid use disorder (OUD) with buprenorphine to track long-term health outcomes for both mothers and their babies. Opioid use disorder during pregnancy is a major public health concern, and buprenorphine is the standard treatment to help manage it safely. This study aims to understand how mother and infant outcomes unfold over time, which can help improve care for this vulnerable population. The study is open to women aged 18 and older who are currently pregnant with a single baby, are taking buprenorphine as part of an antenatal OUD treatment program, and plan to deliver at Methodist, University, or Riley Hospital. Women with serious medical complications or fetuses with known major birth defects are not eligible. You may be eligible if you: - Are a woman aged 18 or older - Are currently pregnant (single pregnancy) - Are enrolled in a prenatal opioid maintenance program and taking buprenorphine - Plan to deliver at Methodist, University, or Riley Hospital You may NOT be eligible if you: - Have a serious maternal medical illness as deemed by the study physician - Have a fetus or newborn with known or suspected major congenital abnormalities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSubutex / Buprenorphine

Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.

DIAGNOSTIC_TESTFetal & Neonatal MRI

Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.

DIAGNOSTIC_TESTDNA/Genetic/Pharmacokenetic Blood Draws

Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.


Locations(1)

UPMC Children's Hospital

Pittsburgh, Pennsylvania, United States

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NCT03923374


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