Maternal Marijuana Use and Fetal and Infant Outcome

Pregnancy Related Clinical Trial

Official title:

Maternal Marijuana Use and Fetal and Infant Outcome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04266314
• Other study ID #: IRB00190055
• Status: Withdrawn
• Start date: April 10, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: February 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse
• Marijuana Use
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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). doi: 10.3791/3368. — View Citation

Pajulo M, Tolvanen M, Karlsson L, Halme-Chowdhury E, Öst 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Infant weight at birth	Birth weight in kilograms	At the time of delivery
Primary	Infant length at birth	Infant length in centimeters	At the time of delivery
Primary	Infant head circumference at birth	Infant head circumference in centimeters	At the time of delivery
Primary	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
Primary	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