Maternal Marijuana Use and Fetal and Infant Outcome

Study Overview
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Brief Summary
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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.

Official Title
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Maternal Marijuana Use and Fetal and Infant Outcome

Conditions
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Cannabis Use Disorder, Pregnancy Related

Intervention / Treatment
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* Device: Maternal-fetal monitoring
* Other: NICU Network Neurobehavioral Scale


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Maternal-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)|
|Other: NICU Network Neurobehavioral Scale|Evaluates neurobehavioral organization, neurological reflexes, motor development, and signs of stress and withdrawal of substance-exposed infants.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Prevalence of maternal cannabis use disorder | Rates of Cannabis use disorder among pregnant women reporting primary or secondary (i.e. first or second drug of choice) cannabis use during pregnancy. | The first day of study enrollment and again at infant delivery | 
| Fetal functioning as assessed by fetal heart rate | Fetal heart rate in beats per minute will be measured. | One day during 36th weeks of gestation | 
| Fetal functioning as assessed by fetal movement | Fetal movement: number and length in msecs of bouts of fetal movement as determined by fetal actograph testing | One day during 36th weeks of gestation | 
| Change in infant neurobehavioral functioning as assessed by the NICU Network Neurobehavioral Scale | Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale scores. | One day during week 1 and week 4 of infant life | 
| Change in Maternal reflective functioning as assessed by the Parental Reflective Functioning Questionnaire | 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. | At 36 weeks of gestation, postpartum week 1, postpartum week 4 | 
| Infant weight at birth | Birth weight in kilograms | At the time of delivery | 
| Infant length at birth | Infant length in centimeters | At the time of delivery | 
| Infant head circumference at birth | Infant head circumference in centimeters | At the time of delivery | 
| Infant Apgar Score at 1 minute | Apgar Score after birth at one minute; scores range from 1-10 with higher scores signifying more optimal infant well being at birth. | At 1 minute after delivery | 
| Infant Apgar Score at 5 minutes | Apgar Score after birth at five minutes; scores range from 1-10 with higher scores signifying more optimal infant well being at birth. | At 5 minutes after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabis