Vaginal Cleansing Before Cesarean Delivery to Reduce Infection
- Conditions
- Complications; Cesarean Section
- Registration Number
- NCT02495753
- Lead Sponsor
- Washington University School of Medicine
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 608
- Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.
- Inability to obtain consent
- known or suspected allergy to iodine or shellfish
- women with active herpes simplex virus infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Composite Postoperative Infectious Morbidity 30 days postoperatively Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection.
- Secondary Outcome Measures
Name Time Method Adverse Reaction to Vaginal Cleansing 30 days postoperatively Hypersensitivity Reaction or more severe allergic reaction
Number of readmissions to hospital for infectious morbidity. 30 days postoperatively Number of times patient is readdmitted for any infectious morbidity.
Number of outpatient visits for infectious morbidiy. 30 days postoperatively. Number of outpatient or emergency room visits related to infectious morbidity.
Treatment for neonatal Sepsis 30 days postoperatively Any antibioitics given for neonate with suspected sepsis.
Length of Hospital Stay 30 days postoperatively Days in hospital
Trial Locations
- Locations (1)
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Barnes Jewish Hospital🇺🇸Saint Louis, Missouri, United States