Clinical trial NCT00653692: Fetal Neurobehavior in Poly-drug Dependent Women
Official title: Methadone, Buprenorphine and Fetal Neurobehavior
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poly Drug Exposed Pregnancies
Keywords: Substance abuse
fetal development
vagal tone
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-04-07
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Poly drug dependent pregnant women

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.

Eligibility criteria: 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

Primary outcomes:
measure: fetal heart rate
timeFrame: 120 minutes
measure: fetal movement
timeFrame: 120 minutes
Secondary outcomes:
measure: neonatal abstinence syndrome
timeFrame: 4 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Center for Addiction and Pregnancy
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lauren M Jansson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansson LM, Di Pietro JA, Elko A, Williams EL, Milio L, Velez M. Pregnancies exposed to methadone, methadone and other illicit substances, and poly-drugs without methadone: a comparison of fetal neurobehaviors and infant outcomes. Drug Alcohol Depend. 2012 May 1;122(3):213-9. doi: 10.1016/j.drugalcdep.2011.10.003. Epub 2011 Oct 29.