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

This study has been terminated.
(Difficulty recruiting)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386477
First Posted: October 11, 2006
Last Update Posted: February 8, 2010
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.
Information provided by:
Indiana University
October 9, 2006
October 11, 2006
November 11, 2009
February 8, 2010
February 8, 2010
September 2006
May 2009   (Final data collection date for primary outcome measure)
Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. [ Time Frame: 1 month ]
  • Postpartum endometritis
  • Postoperative wound complications
  • Composite endometritis plus wound complications
Complete list of historical versions of study NCT00386477 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Cesarean Section
  • Endometritis
  • Surgical Wound Infection
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.
Experimental: Vag prep
Vagina cleansed prior to performing cesarean
Intervention: Procedure: Vaginal cleansing before cesarean delivery
Haas DM, Pazouki F, Smith RR, Fry AM, Podzielinski I, Al-Darei SM, Golichowski AM. Vaginal cleansing before cesarean delivery to reduce postoperative infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2010 Mar;202(3):310.e1-6. doi: 10.1016/j.ajog.2010.01.005.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
May 2009
May 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to iodine containing solutions
  • Planned cesarean hysterectomy
  • Prisoner
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00386477
0509-55 (Study #)
0509-55 ( Other Identifier: IUPUI-Clarian IRB number )
Yes
Not Provided
Not Provided
David M. Haas/ Assistant Professor of OB/GYN, Indiana University School of Medicine
Indiana University School of Medicine
Not Provided
Principal Investigator: David M Haas, MD Indiana University School of Medicine
Indiana University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP