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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
608
The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.
The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.
Barnes Jewish Hospital
St Louis, Missouri, United States
Composite Postoperative Infectious Morbidity
Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection.
Time frame: 30 days postoperatively
Adverse Reaction to Vaginal Cleansing
Hypersensitivity Reaction or more severe allergic reaction
Time frame: 30 days postoperatively
Length of Hospital Stay
Days in hospital
Time frame: 30 days postoperatively
Number of readmissions to hospital for infectious morbidity.
Number of times patient is readdmitted for any infectious morbidity.
Time frame: 30 days postoperatively
Treatment for neonatal Sepsis
Any antibioitics given for neonate with suspected sepsis.
Time frame: 30 days postoperatively
Number of outpatient visits for infectious morbidiy.
Number of outpatient or emergency room visits related to infectious morbidity.
Time frame: 30 days postoperatively.
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