Maternal Marijuana Use and Fetal and Infant Outcome

NCT ID: NCT04266314

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-10
• Study Completion Date: 2021-02-15

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.

Conditions

Cannabis Use Disorder; Pregnancy Related

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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)

Intervention Type: DEVICE

NICU Network Neurobehavioral Scale

Evaluates neurobehavioral organization, neurological reflexes, motor development, and signs of stress and withdrawal of substance-exposed infants.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Singleton pregnancy less than 36 weeks of gestation
• Marijuana as a primary or secondary drug of choice

Exclusion Criteria

• Significant fetal anomaly
• Multiple gestation
• Delivery prior to 36 weeks gestation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Jansson, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26096692 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25177897 (View on PubMed)

Other Identifiers

IRB00190055

Identifier Type: -

Identifier Source: org_study_id