Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial - Full Text View

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

MedlinePlus related topics:

Cesarean Section

ChemIDplus related topics:

Iodine Cadexomer iodine Povidone-iodine Povidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Indiana University:

Primary Outcome Measures:

Composite endometritis plus wound complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	September 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vag prep: Experimental Vagina cleansed prior to performing cesarean	Procedure: Vaginal cleansing before cesarean delivery Cleansing vagina with betadine scrub before cesarean.

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

Contacts


Contact: David M Haas, MD	317-630-7837	dahaas@iupui.edu

Contact: Lyree Mikhail, MD	317-630-6934	lmikhail@iupui.edu

Locations


United States, Indiana
	University Hospital	Recruiting
	Indianapolis, Indiana, United States, 46202
	Sub-Investigator: Alan M Golichowski, MD
	Wishard Memorial Hospital	Recruiting
	Indianapolis, Indiana, United States, 46202
	Contact: David M Haas, MD
	Principal Investigator: David M Haas, MD
	Methodist Hospital	Recruiting
	Indianapolis, Indiana, United States, 46202
	Sub-Investigator: Kim Hoover, MD

Sponsors and Collaborators

Indiana University School of Medicine

Investigators


Principal Investigator:	David M Haas, MD	Indiana University School of Medicine

More Information

Responsible Party:	Indiana University School of Medicine ( David M. Haas/ Assistant Professor of OB/GYN )
Study ID Numbers:	Study #0509-55, 0509-55
First Received:	October 9, 2006
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00386477
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Povidone iodine

postoperative infection

presurgical cleansing

Study placed in the following topic categories:

Genital Diseases, Female

Endometritis

Postoperative Complications

Povidone

Wounds and Injuries

Iodine

Disorders of Environmental Origin

Uterine Diseases

Pelvic Inflammatory Disease

Povidone-Iodine

Surgical Wound Infection

Wound Infection

Additional relevant MeSH terms:

Communicable Diseases

Pathologic Processes

Infection

Adnexal Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00386477