Clinical trial NCT04266314: Maternal Marijuana Use and Fetal and Infant Outcome
Official title: Maternal Marijuana Use and Fetal and Infant Outcome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cannabis Use Disorder
Pregnancy Related
Keywords: Cannabis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-02-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronically marijuana using women enrolled at the Center for Addiction and Pregnancy.

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.


Eligibility 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

Primary outcomes:
measure: Change in Prevalence of maternal cannabis use disorder
timeFrame: The first day of study enrollment and again at infant delivery
measure: Fetal functioning as assessed by fetal heart rate
timeFrame: One day during 36th weeks of gestation
measure: Fetal functioning as assessed by fetal movement
timeFrame: One day during 36th weeks of gestation
measure: Change in infant neurobehavioral functioning as assessed by the NICU Network Neurobehavioral Scale
timeFrame: One day during week 1 and week 4 of infant life
measure: Change in Maternal reflective functioning as assessed by the Parental Reflective Functioning Questionnaire
timeFrame: At 36 weeks of gestation, postpartum week 1, postpartum week 4
measure: Infant weight at birth
timeFrame: At the time of delivery
measure: Infant length at birth
timeFrame: At the time of delivery
measure: Infant head circumference at birth
timeFrame: At the time of delivery
measure: Infant Apgar Score at 1 minute
timeFrame: At 1 minute after delivery
measure: Infant Apgar Score at 5 minutes
timeFrame: At 5 minutes after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lauren Jansson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pajulo M, Tolvanen M, Karlsson L, Halme-Chowdhury E, Ost C, Luyten P, Mayes L, Karlsson H. THE PRENATAL PARENTAL REFLECTIVE FUNCTIONING QUESTIONNAIRE: EXPLORING FACTOR STRUCTURE AND CONSTRUCT VALIDITY OF A NEW MEASURE IN THE FINN BRAIN BIRTH COHORT PILOT STUDY. Infant Ment Health J. 2015 Jul-Aug;36(4):399-414. doi: 10.1002/imhj.21523. Epub 2015 Jun 19.
citation: Lester BM, Andreozzi-Fontaine L, Tronick E, Bigsby R. Assessment and evaluation of the high risk neonate: the NICU Network Neurobehavioral Scale. J Vis Exp. 2014 Aug 25;(90):3368. doi: 10.3791/3368.