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Maternal Marijuana Use and Fetal and Infant Outcome

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ClinicalTrials.gov Identifier: NCT04266314
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cannabis Use Disorder Pregnancy Related Device: Maternal-fetal monitoring Other: NICU Network Neurobehavioral Scale

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Maternal Marijuana Use and Fetal and Infant Outcome
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : April 10, 2021
Estimated Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Change in Prevalence of maternal cannabis use disorder [ Time Frame: 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.

  2. Fetal functioning as assessed by fetal heart rate [ Time Frame: One day during 36th weeks of gestation ]
    Fetal heart rate in beats per minute will be measured.

  3. Fetal functioning as assessed by fetal movement [ Time Frame: 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

  4. Change in infant neurobehavioral functioning as assessed by the NICU Network Neurobehavioral Scale [ Time Frame: One day during week 1 and week 4 of infant life ]
    Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale scores.

  5. Change in Maternal reflective functioning as assessed by the Parental Reflective Functioning Questionnaire [ Time Frame: 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.

  6. Infant weight at birth [ Time Frame: At the time of delivery ]
    Birth weight in kilograms

  7. Infant length at birth [ Time Frame: At the time of delivery ]
    Infant length in centimeters

  8. Infant head circumference at birth [ Time Frame: At the time of delivery ]
    Infant head circumference in centimeters

  9. Infant Apgar Score at 1 minute [ Time Frame: 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.

  10. Infant Apgar Score at 5 minutes [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronically marijuana using women enrolled at the Center for Addiction and Pregnancy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266314


Contacts
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Contact: Krystle McConnell, MPH 410-550-8779 kgreen39@jhmi.edu
Contact: Lauren Jansson, MD 410-550-5438 ljansson@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Krystle McConnell, MPH    410-550-8779    kgreen39@jhmi.edu   
Contact: Lauren Jansson, MD    410-550-8779    ljansson@jhmi.edu   
Sub-Investigator: Martha Velez, MD         
Principal Investigator: Lauren Jansson, MD         
Sub-Investigator: Krystle McConnell, MPH         
Sub-Investigator: Nancy Spencer, RN         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Lauren Jansson, MD Johns Hopkins University

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04266314    
Other Study ID Numbers: IRB00190055
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Cannabis
Additional relevant MeSH terms:
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Marijuana Abuse
Marijuana Use
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders