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
  Purpose

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 Intervention
Cesarean Section
Endometritis
Surgical Wound Infection
Procedure: Vaginal cleansing before cesarean delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: September 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386477

Locations
United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: David M Haas, MD Indiana University School of Medicine
  More Information

No publications provided by Indiana University

Additional 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
Study First Received: October 9, 2006
Results First Received: November 11, 2009
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Povidone iodine
postoperative infection
presurgical cleansing

Additional relevant MeSH terms:
Endometritis
Surgical Wound Infection
Wound Infection
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014