Fetal Neurobehavior in Poly-drug Dependent Women
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ClinicalTrials.gov Identifier: NCT00653692 |
Recruitment Status :
Completed
First Posted : April 7, 2008
Last Update Posted : February 21, 2013
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Condition or disease |
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Poly Drug Exposed Pregnancies |
Study Type : | Observational |
Actual Enrollment : | 29 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Methadone, Buprenorphine and Fetal Neurobehavior |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | August 2010 |
Group/Cohort |
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Observational
Poly drug dependent women
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- fetal heart rate [ Time Frame: 120 minutes ]
- fetal movement [ Time Frame: 120 minutes ]
- neonatal abstinence syndrome [ Time Frame: 4 days ]

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Ages Eligible for Study: | 18 Years to 41 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653692
United States, Maryland | |
The Center for Addiction and Pregnancy | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Lauren M Jansson, MD | Johns Hopkins University |
Responsible Party: | Lauren M. Jansson, Associate Professor of Pediatrics Johns Hopkins University School of Medicine, National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00653692 |
Other Study ID Numbers: |
9811 R01DA019934 ( U.S. NIH Grant/Contract ) DPMCDA |
First Posted: | April 7, 2008 Key Record Dates |
Last Update Posted: | February 21, 2013 |
Last Verified: | February 2013 |
Substance abuse fetal development vagal tone |