Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of maternal opioid relapse
研究概览
简要总结
This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.
详细描述
Background: 7% of pregnant women in the U.S. use opioids and 21% of these women report misuse, making opioid use disorder (OUD) a major public health concern during pregnancy. The number of infants born with prenatal opioid exposure, neonatal opioid withdrawal syndrome (NOWS) and costly prolonged hospitalization has increased exponentially. The opioid epidemic is further worsened by the ongoing COVID-19 pandemic. Despite medication treatment for OUD with buprenorphine (BUP) or methadone (METH), these pregnant women continue to be at high risk for early relapse, polysubstance use, and depression. These infants are at risk for not only immediate NOWS and also poor long-term neurodevelopmental and behavioral outcomes. Genetic factors influence 30-60% of opioid adverse events (AEs). In pregnant women on medication management for OUD, and infants receiving opioids for NOWS treatment there is variability in dose required to prevent withdrawal symptoms and craving, likely related to physiological alterations, upregulation of metabolic and biological pathways, determined in part by opioid pharmacogenomics. Investigators have shown that in children and adults, opioid related poor clinical outcomes are related to opioid receptor genetic variations and resulting variations in their metabolism. Maternal depression and anxiety increase the risks for OUD, maternal relapse, NOWS and negatively impact pregnant women and their children. Thus, there is an urgent and unmet clinical need for a reliable tool to proactively predict maternal relapse, NOWS, and improve the safety of pregnant women with OUD and their children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Pregnant women with OUD and their infant
- •Currently on BUP/METH for OUD
- •Enrolled in prenatal opioid maintenance program
- •Age >18 years
- •Singleton pregnancy
- •Planned delivery at UPMC's Magee Womans Hospital
- •Positive opioid urine screen results
排除标准
- •Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
- •HIV or AIDS
- •Known major fetal congenital abnormalities
研究组 & 干预措施
Pregnant women with Opioid Use Disorder (OUD)
This study will enroll 100 pregnant women with OUD at UPMC with its high volumes
干预措施: Buprenorphine/ Methadone exposure (Drug)
结局指标
主要结局
Incidence of maternal opioid relapse
时间窗: Measured from enrollment to 3-months post delivery
Measured via binary response, yes/no
Incidence of NOWS
时间窗: Measured at delivery
Clinical definition of NOWS: Substance withdrawal encompasses a continuum of variable clinical expression from neonate to neonate; the diagnosis is not limited only to neonates who require pharmacotherapy. Incidence of NOWS measured by binary response, yes/no
次要结局
- Severity of Maternal Opioid Relapse(Measured from enrollment to 3-months post delivery)
- Severity of NOWs(Measured at delivery)
研究者
Ilana Hull
Assistant Professor of Medicine
University of Pittsburgh
