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Fetal Neurobehavior in Poly-drug Dependent Women

Methadone, Buprenorphine and Fetal Neurobehavior

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00653692
Enrollment
29
Registered
2008-04-07
Start date
2007-05-31
Completion date
2010-08-31
Last updated
2013-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poly Drug Exposed Pregnancies

Keywords

Substance abuse, fetal development, vagal tone

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.

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.

Interventions

None listed

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
fetal heart rate120 minutes
fetal movement120 minutes

Secondary

MeasureTime frame
neonatal abstinence syndrome4 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026