NCT02495753

Vaginal Cleansing Before Cesarean Delivery to Reduce Infection

Vaginal Cleansing Before Cesarean Delivery to Reduce Infection: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 608 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

Detailed description

Cesarean delivery is the most common surgical procedure performed on women in the US; nearly 1.3 million are performed each year. Postoperative infectious morbidity is the most common complication of cesarean delivery. Post-cesarean infectious morbidity is often the result of indigenous vaginal flora that ascend into the uterus at the time of surgery. Thus, reducing vaginal microbial load may reduce post-cesarean infection. However, results from studies assessing the role of vaginal cleansing prior to cesarean have been mixed. The investigators will perform a randomized controlled clinical trial to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

Conditions

• Complications; Cesarean Section

Interventions

Type	Name	Description
PROCEDURE	Vaginal Cleansing	The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.
PROCEDURE	Abdominal Cleansing	The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.

Timeline

• Start date: 2015-08-01
• Primary completion: 2021-01-01
• Completion: 2021-04-01
• First posted: 2015-07-13
• Last updated: 2021-08-06

Locations

1 site across 1 country: United States