Cannabis Use Disorder, Pregnancy Related
Conditions
Keywords
Cannabis
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.
Interventions
DEVICEMaternal-fetal monitoring
Maternal-fetal monitoring evaluates fetal and maternal heart rate, maternal respirations, fetal movement, and maternal skin conductance (a way to monitor emotional response)
OTHERNICU Network Neurobehavioral Scale
Evaluates neurobehavioral organization, neurological reflexes, motor development, and signs of stress and withdrawal of substance-exposed infants.
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
Maternal Inclusion Criteria: * Singleton pregnancy less than 36 weeks of gestation * Marijuana as a primary or secondary drug of choice Maternal
Exclusion criteria
* Significant fetal anomaly * Multiple gestation * Delivery prior to 36 weeks gestation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant weight at birth | At the time of delivery | Birth weight in kilograms |
| 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. |
| 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. |
| 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 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 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 |
| Infant head circumference at birth | At the time of delivery | Infant head circumference in centimeters |
| 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. |
Countries
United States
Outcome results
None listed