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Completed

NCT Number: NCT00653692

Fetal Neurobehavior in Poly-drug Dependent Women

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.

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Key information

Conditions

Poly Drug Exposed Pregnancies Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–41 year

Sex eligibility

Female

Study type

Observational

Primary location

The Center for Addiction and Pregnancy

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. fetal heart rate

    Time frame: 120 minutes

  2. fetal movement

    Time frame: 120 minutes

Secondary outcomes

  1. neonatal abstinence syndrome

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Methadone, Buprenorphine and Fetal Neurobehavior

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 7, 2008
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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