Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial

This study has been terminated.
(Difficulty recruiting)
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00386477
First received: October 9, 2006
Last updated: January 14, 2010
Last verified: December 2010
Results First Received: November 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Cesarean Section
Endometritis
Surgical Wound Infection
Intervention: Procedure: Vaginal cleansing before cesarean delivery

  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
No text entered.

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

Reporting Groups
  Description
Vag Prep Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
Control No vaginal cleansing or sham wash performed.

Participant Flow:   Overall Study
    Vag Prep     Control  
STARTED     155     145  
COMPLETED     155     145  
NOT COMPLETED     0     0  



  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
  Description
Vag Prep Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
Control No vaginal cleansing or sham wash performed.
Total Total of all reporting groups

Baseline Measures
    Vag Prep     Control     Total  
Number of Participants  
[units: participants]
  155     145     300  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     155     145     300  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  26.8  ± 5.9     26.6  ± 5.7     26.7  ± 5.8  
Gender  
[units: participants]
     
Female     155     145     300  
Male     0     0     0  
Race/Ethnicity, Customized [1]
[units: participants]
  155     145     300  
Region of Enrollment  
[units: participants]
     
United States     155     145     300  
[1] African-American Caucasian Hispanic Other



  Outcome Measures

1.  Primary:   Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.   [ Time Frame: 1 month ]


  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
The study was stopped before the planned enrollment of 1000 due to difficulty recruiting. Results are of a planned safety analysis at 300 subjects.


  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: David M. Haas, MD, MS
Organization: Indiana University School of Medicine
phone: 317-630-7837
e-mail: dahaas@iupui.edu


No publications provided by Indiana University

Publications automatically indexed to this study:

Responsible Party: David M. Haas/ Assistant Professor of OB/GYN, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00386477     History of Changes
Other Study ID Numbers: 0509-55 (Study #), 0509-55
Study First Received: October 9, 2006
Results First Received: November 11, 2009
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board