Fetal Neurobehavior in Poly-drug Dependent Women

Completed

• Conditions: Poly Drug Exposed Pregnancies

• Registration Number: NCT00653692
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-07
• Primary Completion: 2010-02
• Study Completion: 2010-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fetal heart rate	120 minutes
fetal movement	120 minutes

Secondary Outcome Measures

Name	Time	Method
neonatal abstinence syndrome	4 days

Trial Locations

Locations (1)

The Center for Addiction and Pregnancy; 🇺🇸 Baltimore, Maryland, United States