Vaginal Cleansing Before Cesarean Delivery to Reduce Infection

Study Overview
=================
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.

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

Conditions
-----------------
Complications; Cesarean Section

Intervention / Treatment
-----------------
* Procedure: Vaginal Cleansing
* Procedure: Abdominal Cleansing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital. Exclusion Criteria: Inability to obtain consent known or suspected allergy to iodine or shellfish women with active herpes simplex virus infection
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal and Vaginal Cleansing<br>In the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section. | Procedure: Vaginal Cleansing<br>* The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.<br>Procedure: Abdominal Cleansing<br>* The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.<br>|
| Active Comparator: Abdominal Cleansing Alone<br>In the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing. | Procedure: Abdominal Cleansing<br>* The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Postoperative Infectious Morbidity | Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection. | 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Reaction to Vaginal Cleansing | Hypersensitivity Reaction or more severe allergic reaction | 30 days postoperatively | 
| Length of Hospital Stay | Days in hospital | 30 days postoperatively | 
| Number of readmissions to hospital for infectious morbidity. | Number of times patient is readdmitted for any infectious morbidity. | 30 days postoperatively | 
| Treatment for neonatal Sepsis | Any antibioitics given for neonate with suspected sepsis. | 30 days postoperatively | 
| Number of outpatient visits for infectious morbidiy. | Number of outpatient or emergency room visits related to infectious morbidity. | 30 days postoperatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean section, wound infection, vaginal cleansing, endometritis