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
|Condition or disease||Intervention/treatment|
|Cannabis Use Disorder Pregnancy Related||Device: Maternal-fetal monitoring Other: NICU Network Neurobehavioral Scale|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|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|
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Infant weight at birth [ Time Frame: At the time of delivery ]Birth weight in kilograms
- Infant length at birth [ Time Frame: At the time of delivery ]Infant length in centimeters
- Infant head circumference at birth [ Time Frame: At the time of delivery ]Infant head circumference in centimeters
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266314
|Contact: Krystle McConnell, MPHfirstname.lastname@example.org|
|Contact: Lauren Jansson, MDemail@example.com|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Krystle McConnell, MPH 410-550-8779 firstname.lastname@example.org|
|Contact: Lauren Jansson, MD 410-550-8779 email@example.com|
|Sub-Investigator: Martha Velez, MD|
|Principal Investigator: Lauren Jansson, MD|
|Sub-Investigator: Krystle McConnell, MPH|
|Sub-Investigator: Nancy Spencer, RN|
|Principal Investigator:||Lauren Jansson, MD||Johns Hopkins University|