Maternal Marijuana Use and Fetal and Infant Outcome

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.

Study Overview

• Status: Withdrawn
• Conditions: Pregnancy Related; Cannabis Use Disorder
• Intervention / Treatment: Device: Maternal-fetal monitoring; Other: NICU Network Neurobehavioral Scale

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Chronically marijuana using women enrolled at the Center for Addiction and Pregnancy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lauren Jansson, MD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2019
• Primary Completion (ACTUAL): February 15, 2021
• Study Completion (ACTUAL): February 15, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (ACTUAL): February 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Cannabis
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Marijuana Use
• Other Study ID Numbers: IRB00190055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No