Fetal Neurobehavior in Non-methadone Maintained Women in Substance Abuse Treatment

Completed

Conditions studied: Pregnancy, Drug Abuse

In brief

This study seeks to elucidate fetal neurobehavioral development in fetuses of opioid dependent women who have either undergone and completed methadone detoxification,or who never received methadone maintenance, and are not methadone maintained at 36 weeks gestation. This research will determine how fetal neurobehavioral functioning in fetuses of opioid dependent, non-methadone maintained women differs from that of fetuses whose opioid dependent mothers are methadone maintained. The project will utilize a state-of-the-art computerized fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart rate, the interaction between the two and maternal physiologic parameters.

Key facts

Study ID

NCT00522626

Run by

Johns Hopkins University

People needed

19

Starts

2006-08-01

Expected to finish

2010-08-01

Last updated by the study team

2016-03-01

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Generally healthy women between ages 18 and 40, current clients of the CAP program
• Singleton, uncomplicated pregnancies, dated with routine 16 to 20 week ultrasound (as is part of standard care at CAP)
• Abstinence from licit and illicit substance abuse in the four weeks prior to consent

You may not qualify if…

• Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or preterm labor
• Significant maternal health problems related to pregnancy, including HIV infection and Type I diabetes
• Significant maternal psychopathology or other pathology that would preclude informed consent (schizophrenia, mental retardation)
• Recent drug use, defined as positive urine toxicology (performed randomly at least weekly in the treatment center), clinical positives (subject appearing intoxicated at the treatment center) or patient report in the four weeks prior to recruitment, or at any time during study participation (i.e. from 28 weeks to 36 weeks gestation)
• Recent alcohol use, by clinical detection, patient report or breathalyzer reading (performed at the treatment center to confirm clinical impression) at any time in the four weeks prior to recruitment, or at any time during study participation

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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