Cannabis Use DisorderNCT04266314
Maternal Marijuana Use and Fetal and Infant Outcome
An observational study of Cannabis Use Disorder and Pregnancy Related, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Cannabis Use Disorder, Pregnancy Related
- What is being tested?
- Maternal-fetal monitoring and NICU Network Neurobehavioral Scale
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Chronically marijuana using women enrolled at the Center for Addiction and Pregnancy.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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
- Being tested
- Maternal-fetal monitoring, NICU Network Neurobehavioral Scale
- Keywords
- Cannabis
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal-fetal monitoringDevice
Maternal-fetal monitoring evaluates fetal and maternal heart rate, maternal respirations, fetal movement, and maternal skin conductance (a way to monitor emotional response)
NICU Network Neurobehavioral ScaleOther
Evaluates neurobehavioral organization, neurological reflexes, motor development, and signs of stress and withdrawal of substance-exposed infants.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: 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.
Measured: 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.
Measured: At 36 weeks of gestation, postpartum week 1, postpartum week 4
Infant weight at birth
Birth weight in kilograms
Measured: At the time of delivery
Infant length at birth
Infant length in centimeters
Measured: At the time of delivery
Infant head circumference at birth
Infant head circumference in centimeters
Measured: 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.
Measured: 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.
Measured: At 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start10 Apr 2019
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Why it stopped: unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Lauren Jansson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266314
- Sponsor's protocol ID
- IRB00190055
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26096692Lester 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.
PubMed 25177897
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Marijuana Use and Fetal and Infant Outcome
- ClinicalTrials.gov ID
- NCT04266314
- Acronym / sponsor ID
- IRB00190055
- Conditions
- Cannabis Use Disorder, Pregnancy Related
- Keywords
- Cannabis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: unable to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Chronically marijuana using women enrolled at the Center for Addiction and Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal-fetal monitoringMaternal-fetal monitoring evaluates fetal and maternal heart rate, maternal respirations, fetal movement, and maternal skin conductance (a way to monitor emotional response) | Device | – |
| NICU Network Neurobehavioral ScaleEvaluates neurobehavioral organization, neurological reflexes, motor development, and signs of stress and withdrawal of substance-exposed infants. | Other | – |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 26096692Pajulo 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.
- Background: PubMed 25177897Lester 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Jansson, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis Use Disorder and Pregnancy Related, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prevalence of maternal cannabis use disorder (time frame: The first day of study enrollment and again at infant delivery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266314, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.