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Fetal Neurobehavior in Poly-drug Dependent Women

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Johns Hopkins University

Status

Completed

Conditions

Poly Drug Exposed Pregnancies

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00653692
9811
R01DA019934 (U.S. NIH Grant/Contract)
DPMCDA

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

Female

Ages

18 to 41 years old

Volunteers

No Healthy Volunteers

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

Trial design

29 participants in 1 patient group

Observational
Description:
Poly drug dependent women

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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