Vaginal Cleansing Before Cesarean Delivery to Reduce Infection
Primary Purpose
Complications; Cesarean Section
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vaginal Cleansing
Abdominal Cleansing
Sponsored by

About this trial
This is an interventional prevention trial for Complications; Cesarean Section focused on measuring cesarean section, wound infection, vaginal cleansing, endometritis
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
Sites / Locations
- Barnes Jewish Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Abdominal and Vaginal Cleansing
Abdominal Cleansing Alone
Arm Description
In the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section.
In the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing.
Outcomes
Primary Outcome Measures
Composite Postoperative Infectious Morbidity
Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection.
Secondary Outcome Measures
Adverse Reaction to Vaginal Cleansing
Hypersensitivity Reaction or more severe allergic reaction
Length of Hospital Stay
Days in hospital
Number of readmissions to hospital for infectious morbidity.
Number of times patient is readdmitted for any infectious morbidity.
Treatment for neonatal Sepsis
Any antibioitics given for neonate with suspected sepsis.
Number of outpatient visits for infectious morbidiy.
Number of outpatient or emergency room visits related to infectious morbidity.
Full Information
NCT ID
NCT02495753
First Posted
June 28, 2015
Last Updated
August 5, 2021
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02495753
Brief Title
Vaginal Cleansing Before Cesarean Delivery to Reduce Infection
Official Title
Vaginal Cleansing Before Cesarean Delivery to Reduce Infection: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
April 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Cesarean Section
Keywords
cesarean section, wound infection, vaginal cleansing, endometritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
608 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abdominal and Vaginal Cleansing
Arm Type
Experimental
Arm Description
In the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section.
Arm Title
Abdominal Cleansing Alone
Arm Type
Active Comparator
Arm Description
In the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing.
Intervention Type
Procedure
Intervention Name(s)
Vaginal Cleansing
Intervention Description
The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.
Intervention Type
Procedure
Intervention Name(s)
Abdominal Cleansing
Intervention Description
The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.
Primary Outcome Measure Information:
Title
Composite Postoperative Infectious Morbidity
Description
Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection.
Time Frame
30 days postoperatively
Secondary Outcome Measure Information:
Title
Adverse Reaction to Vaginal Cleansing
Description
Hypersensitivity Reaction or more severe allergic reaction
Time Frame
30 days postoperatively
Title
Length of Hospital Stay
Description
Days in hospital
Time Frame
30 days postoperatively
Title
Number of readmissions to hospital for infectious morbidity.
Description
Number of times patient is readdmitted for any infectious morbidity.
Time Frame
30 days postoperatively
Title
Treatment for neonatal Sepsis
Description
Any antibioitics given for neonate with suspected sepsis.
Time Frame
30 days postoperatively
Title
Number of outpatient visits for infectious morbidiy.
Description
Number of outpatient or emergency room visits related to infectious morbidity.
Time Frame
30 days postoperatively.
Other Pre-specified Outcome Measures:
Title
Prespecified Stratified Analysis for Subgroups
Description
Planned secondary analysis will be aimed at obtaining adjusted assessments of treatment effectiveness with interaction tests used to determine if the effectiveness of vaginal cleansing differs across subgroups. Subgroups include BMI categories, rupture status, chorioamnionitis, stage of labor, cervical dilation >6 cm, gestational age, use of monitors, time in labor, duration of rupture, presence of GBS, labor status, and use of ripening agents.
Time Frame
30 days postoperatively
Title
Prespecified Stratified Analysis for Subgroups
Description
Planned secondary analysis will be performed in order to obtain adjusted assessment of treatment effectiveness in subgroups stratified based on the following: administration of azithromycin and time of enrolment date in relation to hospital protocol adjustments for Covid19 screening.
Time Frame
30 days postoperatively
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32335895
Citation
Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Results Reference
derived
Learn more about this trial
Vaginal Cleansing Before Cesarean Delivery to Reduce Infection
We'll reach out to this number within 24 hrs