Maternal Marijuana Use and Fetal and Infant Outcome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Infant Apgar Score at 1 minute
研究概览
简要总结
Marijuana and cannabis-containing products are growing in popularity and availability in the United States, and use during pregnancy has increased dramatically. The overarching aim of this proposal is to provide pilot data for a submission which will explore the impact of chronic maternal marijuana use (primary or secondary) on fetal functioning, maternal reflective functioning and infant birth and neurodevelopmental outcomes. Chronically marijuana using pregnant women in treatment at the Center for Addiction and Pregnancy will be enrolled and asked to provide information about participants' marijuana and other licit and illicit substance use and feelings about parenting and participants' infant and undergo fetal monitoring at 36 weeks gestation. The neonates will undergo neurobehavioral examination during the first and fourth weeks of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy less than 36 weeks of gestation
- •Marijuana as a primary or secondary drug of choice
排除标准
- •Significant fetal anomaly
- •Multiple gestation
- •Delivery prior to 36 weeks gestation
结局指标
主要结局
Infant Apgar Score at 1 minute
时间窗: At 1 minute after delivery
Apgar Score after birth at one minute; scores range from 1-10 with higher scores signifying more optimal infant well being at birth.
Infant Apgar Score at 5 minutes
时间窗: At 5 minutes after delivery
Apgar Score after birth at five minutes; scores range from 1-10 with higher scores signifying more optimal infant well being at birth.
Change in infant neurobehavioral functioning as assessed by the NICU Network Neurobehavioral Scale
时间窗: One day during week 1 and week 4 of infant life
Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale scores.
Change in Prevalence of maternal cannabis use disorder
时间窗: The first day of study enrollment and again at infant delivery
Rates of Cannabis use disorder among pregnant women reporting primary or secondary (i.e. first or second drug of choice) cannabis use during pregnancy.
Infant head circumference at birth
时间窗: At the time of delivery
Infant head circumference in centimeters
Fetal functioning as assessed by fetal movement
时间窗: One day during 36th weeks of gestation
Fetal movement: number and length in msecs of bouts of fetal movement as determined by fetal actograph testing
Infant weight at birth
时间窗: At the time of delivery
Birth weight in kilograms
Fetal functioning as assessed by fetal heart rate
时间窗: One day during 36th weeks of gestation
Fetal heart rate in beats per minute will be measured.
Change in Maternal reflective functioning as assessed by the Parental Reflective Functioning Questionnaire
时间窗: At 36 weeks of gestation, postpartum week 1, postpartum week 4
Responses that evaluate the mother's ability to reflect on and interpret her own behavior and that of her child in terms of mental states and intentions; this will be assessed using the Parental Reflective Functioning Questionnaire.
Infant length at birth
时间窗: At the time of delivery
Infant length in centimeters
次要结局
未报告次要终点