Maternal Marijuana Use and Fetal and Infant Outcome
- Conditions
- Cannabis Use DisorderPregnancy Related
- Registration Number
- NCT04266314
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- Singleton pregnancy less than 36 weeks of gestation
- Marijuana as a primary or secondary drug of choice
Maternal
- Significant fetal anomaly
- Multiple gestation
- Delivery prior to 36 weeks gestation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in infant neurobehavioral functioning as assessed by the NICU Network Neurobehavioral Scale 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 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 At the time of delivery Infant head circumference in centimeters
Infant weight at birth At the time of delivery Birth weight in kilograms
Fetal functioning as assessed by fetal heart rate One day during 36th weeks of gestation Fetal heart rate in beats per minute will be measured.
Infant Apgar Score at 1 minute 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 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.
Fetal functioning as assessed by fetal movement 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
Change in Maternal reflective functioning as assessed by the Parental Reflective Functioning Questionnaire 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 At the time of delivery Infant length in centimeters
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States