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Fetal Neurobehavior in Poly-drug Dependent Women

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ClinicalTrials.gov Identifier: NCT00653692
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : February 21, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lauren M. Jansson, National Institute on Drug Abuse (NIDA)

Study Description
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Brief Summary:
This project examines fetal neurobehavior and maternal physiology in poly-drug dependent women. This study also evaluates infant neonatal abstinence syndrome, infant neurobehavior and vagal tone in the post-partum period.

Condition or disease
Poly Drug Exposed Pregnancies

Detailed Description:
Little is known about the link between maternal physiology, fetal neurobehavior and neonatal abstinence syndrome in multiply drug-dependent women. Previous research by this group of investigators has found that the severity of neonatal abstinence syndrome in methadone exposed infants is related to maternal vagal tone changes in response to methadone during pregnancy. While previous research has focused on drug abstinent, methadone maintained women, most drug dependent pregnant women are poly-substance abusers who also use prescription psychiatric medications, alcohol and nicotine. This protocol seeks to further our understanding of the effects of multiple drugs on the fetus, including the co-variate effects of maternal psychological status. Infant neurobehavior and vagal tone will also be evaluated. This research will extend our knowledge of fetal neurobehavioral development and neonatal abstinence syndrome in a realistic population of poly-drug dependent women, potentially altering the way in which these women are evaluated and their infants monitored and treated for neonatal abstinence syndrome.
Study Design
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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Methadone, Buprenorphine and Fetal Neurobehavior
Study Start Date : May 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : August 2010
Groups and Cohorts
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Group/Cohort
Observational
Poly drug dependent women


Outcome Measures
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Primary Outcome Measures :
  1. fetal heart rate [ Time Frame: 120 minutes ]
  2. fetal movement [ Time Frame: 120 minutes ]

Secondary Outcome Measures :
  1. neonatal abstinence syndrome [ Time Frame: 4 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Poly drug dependent pregnant women
Criteria

Inclusion Criteria:

  • Age 18-41
  • Single intrauterine fetus
  • Free of significant maternal or fetal significant health complications

Exclusion Criteria:

  • Development of significant maternal or fetal health complications
  • Significant maternal psychopathology that would preclude informed consent
  • Unwilling or unable to receive methadone at prescribed times
Contacts and Locations
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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): NCT00653692


Locations
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United States, Maryland
The Center for Addiction and Pregnancy
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Lauren M Jansson, MD Johns Hopkins University
More Information
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Publications of Results:

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Responsible Party: Lauren M. Jansson, Associate Professor of Pediatrics Johns Hopkins University School of Medicine, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00653692    
Other Study ID Numbers: 9811
R01DA019934 ( U.S. NIH Grant/Contract )
DPMCDA
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013
Keywords provided by Lauren M. Jansson, National Institute on Drug Abuse (NIDA):
Substance abuse
fetal development
vagal tone