Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of opioid misuse severity using assessments
研究概览
简要总结
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).
详细描述
One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Serious maternal medical illness as deemed by study physician or investigator.
- •Known or suspected major fetal/neonatal congenital abnormalities.
研究组 & 干预措施
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine
干预措施: Subutex / Buprenorphine (Drug)
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine
干预措施: Fetal & Neonatal MRI (Diagnostic Test)
Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine
干预措施: DNA/Genetic/Pharmacokenetic Blood Draws (Diagnostic Test)
Pregnant Mothers
Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder.
干预措施: Fetal & Neonatal MRI (Diagnostic Test)
Pregnant Mothers
Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder.
干预措施: DNA/Genetic/Pharmacokenetic Blood Draws (Diagnostic Test)
结局指标
主要结局
Incidence of opioid misuse severity using assessments
时间窗: 5 years
Incidence of opioid misuse severity and buprenorphine treatment response will be assessed by the treating physician using assessments such as Who Assist, TCU Motform, Adverse Childhood Experience Assessment, Ham-A and Ham-D.
Pharmacological treatment for neonatal abstinence syndrome
时间窗: 5 years
Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.
次要结局
- Incidence of adverse effects of buprenorphine using MRI(5 years)
- Concentration of long-term neurodevelopmental outcomes using assessments(5 years)
研究者
Senthil Sadhasivam
Professor
University of Pittsburgh