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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00522626
Recruitment Status : Completed
First Posted : August 30, 2007
Results First Posted : May 16, 2014
Last Update Posted : March 1, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lauren M. Jansson, Johns Hopkins University

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Pregnancy
Drug Abuse
Intervention: Device: Maternal fetal monitoring

  Participant Flow

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
Lost to Follow-up                7 

  Baseline Characteristics

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
Overall Participants Analyzed 
[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.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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

Publications of Results:
Other Publications:

Responsible Party: Lauren M. Jansson, Johns Hopkins University Identifier: NCT00522626     History of Changes
Other Study ID Numbers: 1490
R01DA019934 ( U.S. NIH Grant/Contract )
First Submitted: August 29, 2007
First Posted: August 30, 2007
Results First Submitted: April 25, 2012
Results First Posted: May 16, 2014
Last Update Posted: March 1, 2016