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

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lauren M. Jansson, Johns Hopkins University
ClinicalTrials.gov Identifier:
First received: August 29, 2007
Last updated: April 17, 2014
Last verified: February 2013
Results First Received: April 25, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Pregnancy
Drug Abuse
Intervention: Device: Maternal fetal monitoring

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment occured between May 2006 and May 2009 from a drug treatment facility treating pregnant and postpartum drug dependent women

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Observational Opioid exposed pregnancies

Participant Flow:   Overall Study
STARTED     19  
COMPLETED     12  
Lost to Follow-up                 7  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Observational Opioid exposed pregnancies

Baseline Measures
Number of Participants  
[units: participants]
[units: years]
Mean (Standard Deviation)
  30.25  (7.38)  
[units: participants]
Female     19  
Male     0  
Region of Enrollment  
[units: participants]
United States     19  

  Outcome Measures

1.  Primary:   Fetal Heart Rate   [ Time Frame: 60 minutes ]

2.  Secondary:   Maternal Physiologic Parameters   [ Time Frame: 120 minutes ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Difficulty in recruiting leading to small number of subjects analyzed

  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Lauren Jansson
Organization: Johns Hopkins University School of Medicine
phone: 410-550-5438
e-mail: ljansson@jhmi.edu

Publications of Results:
Other Publications:

Responsible Party: Lauren M. Jansson, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00522626     History of Changes
Other Study ID Numbers: 1490
R01DA019934 ( US NIH Grant/Contract Award Number )
Study First Received: August 29, 2007
Results First Received: April 25, 2012
Last Updated: April 17, 2014
Health Authority: United States: Federal Government