An observational study in Poly Drug Exposed Pregnancies, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2013-02-21.
Sponsored by Johns Hopkins University · Observational
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.
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.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Poly drug dependent pregnant women
Exclusion Criteria:
Poly drug dependent women
fetal heart rate
Time frame: 120 minutes
fetal movement
Time frame: 120 minutes
neonatal abstinence syndrome
Time frame: 4 days
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University