Fetal Neurobehavior in Poly-drug Dependent Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lauren M. Jansson, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00653692
First received: April 3, 2008
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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
Poly Drug Exposed Pregnancies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Methadone, Buprenorphine and Fetal Neurobehavior

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • fetal heart rate [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
  • fetal movement [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • neonatal abstinence syndrome [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: May 2007
Study Completion Date: August 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational
Poly drug dependent women

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.

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653692

Locations
United States, Maryland
The Center for Addiction and Pregnancy
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Lauren M Jansson, MD Johns Hopkins University
  More Information

Publications:
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     History of Changes
Other Study ID Numbers: 9811, R01DA019934, DPMCDA
Study First Received: April 3, 2008
Last Updated: February 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Substance abuse
fetal development
vagal tone

ClinicalTrials.gov processed this record on July 29, 2014