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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
Sponsor:
Information provided by:
Indiana University

Study Description
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Brief Summary:
The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby. If this is the case, cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant, giving a healthier start for the family.

Condition or disease Intervention/treatment Phase
Cesarean Section Endometritis Surgical Wound Infection Procedure: Vaginal cleansing before cesarean delivery Not Applicable

Detailed Description:

Infectious morbidity frequently complicates cesarean delivery. Endometritis can complicate the postoperative course of a cesarean delivery 6-27% of the time. This complication, up to 10 times more frequent than after vaginal delivery, can lead to serious complications. Additionally, cesarean deliveries are frequently complicated by maternal fever and wound complications including seroma, hematoma, infection, and separation. These morbidities can lead to significant delay in a return to normal function. Our study will randomize 1000 women who are about to undergo a cesarean delivery into one of two groups. The control group will receive the standard surgical preparation of the abdomen alone, the current standard pre-cesarean preparation. The other group will also receive a povidone iodine washing/scrub of the vagina before the cesarean delivery. Maternal and surgical variables will be recorded. At one months postpartum, maternal outpatient data will be reviewed and the incidence of postpartum uterine infection, wound separations, and other wound and infectious complications will be determined and compared between the two treatment groups.

Comparison: Women receiving standard surgical abdominal cleansing versus women receiving standard abdominal and preoperative vaginal cleansing before cesarean delivery.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
Study Start Date : September 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vag prep
Vagina cleansed prior to performing cesarean
 Procedure: Vaginal cleansing before cesarean delivery
Cleansing vagina with 1% betadine scrub before cesarean.
Other Name: 1% betadine scrub of vagina with vaginal scrub spongesticks.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. [ Time Frame: 1 month ]
    Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman undergoing cesarean delivery
  • At least 18 years of age

Exclusion Criteria:

  • Allergy to iodine containing solutions
  • Planned cesarean hysterectomy
  • Prisoner
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00386477


Locations
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United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
University Hospital
Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
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Principal Investigator: David M Haas, MD Indiana University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: David M. Haas/ Assistant Professor of OB/GYN, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00386477    
Other Study ID Numbers: 0509-55 (Study #)
0509-55 ( Other Identifier: IUPUI-Clarian IRB number )
First Posted: October 11, 2006    Key Record Dates
Results First Posted: February 8, 2010
Last Update Posted: February 8, 2010
Last Verified: December 2010
Keywords provided by Indiana University:
Povidone iodine
postoperative infection
presurgical cleansing
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Wound Infection
Surgical Wound Infection
Endometritis
Surgical Wound
Disease Attributes
Pathologic Processes
 Wounds and Injuries
Postoperative Complications
Pelvic Inflammatory Disease
Adnexal Diseases
Uterine Diseases
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents