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

Not Applicable

Terminated

• Conditions: Cesarean Section; Endometritis; Surgical Wound Infection
• Interventions: Procedure: Vaginal cleansing before cesarean delivery

• Registration Number: NCT00386477
• Lead Sponsor: Indiana University School of Medicine

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.

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-09
• Study First Submitted QC: 2006-10-09
• Study First Posted: 2006-10-11
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2009-11-11
• Results First Submitted QC: 2010-01-14
• Last Update Submitted: 2010-01-14
• Results First Posted: 2010-02-08
• Last Update Posted: 2010-02-08
• Status Verified: 2010-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Allergy to iodine containing solutions
• Planned cesarean hysterectomy
• Prisoner

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vag prep	Vaginal cleansing before cesarean delivery	Vagina cleansed prior to performing cesarean

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.	1 month	Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.

Trial Locations

Locations (3)

Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Wishard Memorial Hospital; 🇺🇸 Indianapolis, Indiana, United States