Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Alterations in fetal brain volume
研究概览
简要总结
The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are:
- Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment.
- To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment.
In this study participants will:
- Receive two placental-fetal MRIs, one during second trimester and one in third trimester.
- Answer surveys relating to their medical and social history.
- Have blood drawn during pregnancy and delivery.
- Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with opioid use disorder
- •Inclusion Criteria:
- •Age >18 years
- •Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
- •Singleton Pregnancy
- •Planned delivery at Indiana University or University of Pittsburgh study sites
排除标准
- •Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
- •Known or suspected major fetal/ neonatal congenital abnormalities
- •HIV or AIDS
- •Infants with prenatal opioid exposure:
- •Prenatal buprenorphine or methadone exposure
- •Born to mother enrolled in Opioid Use Disorder arm of study
- •Major congenital anomalies or genetic syndromes affecting neurodevelopment
- •Control Pregnant Women:
- •Women >18 Years of age
- •Healthy singleton pregnancy
- •Planned delivery at Indiana University or University of Pittsburgh study sites
- •Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
- •HIV or AIDS
- •Known or suspected major fetal congenital abnormalities
- •Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.
- •Control infants:
- •Born to control pregnant mother enrolled in study
- •Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.
研究组 & 干预措施
Pregnant Mothers with Opioid Use Disorder
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
干预措施: Fetal and Placental MRI (Diagnostic Test)
Pregnant Mothers with Opioid Use Disorder
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
干预措施: Questionnaires (Behavioral)
Pregnant Mothers with Opioid Use Disorder
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
干预措施: Blood and Placental Samples (Other)
Pregnant Mothers
100 pregnant mother who to not have a history of opioid use disorder
干预措施: Fetal and Placental MRI (Diagnostic Test)
Pregnant Mothers
100 pregnant mother who to not have a history of opioid use disorder
干预措施: Questionnaires (Behavioral)
Pregnant Mothers
100 pregnant mother who to not have a history of opioid use disorder
干预措施: Blood and Placental Samples (Other)
Pregnant Mothers
100 pregnant mother who to not have a history of opioid use disorder
干预措施: Child Developmental Assessment (Behavioral)
Pregnant Mothers with Opioid Use Disorder
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
干预措施: Buprenorphine or Methadone Treatment (Drug)
Pregnant Mothers with Opioid Use Disorder
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
干预措施: Child Developmental Assessment (Behavioral)
结局指标
主要结局
Alterations in fetal brain volume
时间窗: Between 20 weeks gestation and delivery
Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls
Differences in placenta signal
时间窗: Between 20 weeks gestation and delivery
Comparing differences in placenta signal using MRI between the POE group and controls
次要结局
- Placental dysfunction biomarkers related to POE(Between 20 weeks gestation and delivery)
- Ages and Stages Questionnaire Scores during infancy(After birth through one year of life)
- Placental epigenetic changes related to POE(Between 20 weeks gestation and delivery)
- Neurocognitive and behavioral development assessment (Bayley-4) at one year of age(After birth through one year of life)
- Neonatal Opioid Withdrawal Syndrome (NOWS) severity(After birth through one year of life)
- Length of Hospital Stay(After birth through one year of life)
研究者
Senthil Sadhasivam
Professor
University of Pittsburgh