We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00386477
Recruitment Status : Terminated (Difficulty recruiting)
First Posted : October 11, 2006
Results First Posted : February 8, 2010
Last Update Posted : February 8, 2010
Information provided by:
Indiana University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Cesarean Section
Surgical Wound Infection
Intervention: Procedure: Vaginal cleansing before cesarean delivery

  Participant Flow

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
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 

  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
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 
Overall Participants Analyzed 
[Units: Participants]
 155   145   300 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   155   145   300 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 26.8  (5.9)   26.6  (5.7)   26.7  (5.8) 
[Units: Participants]
Female   155   145   300 
Male   0   0   0 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 155   145   300 
[1] African-American Caucasian Hispanic Other
Region of Enrollment 
[Units: Participants]
United States   155   145   300 

  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

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 ( Other Identifier: IUPUI-Clarian IRB number )
First Submitted: October 9, 2006
First Posted: October 11, 2006
Results First Submitted: November 11, 2009
Results First Posted: February 8, 2010
Last Update Posted: February 8, 2010