Vaginal Cleansing Before Cesarean Delivery to Reduce Infection

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

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.

Study Overview

• Status: Completed
• Conditions: Complications; Cesarean Section
• Intervention / Treatment: Procedure: Vaginal Cleansing; Procedure: Abdominal Cleansing

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.

• Study Type: Interventional
• Enrollment (Actual): 608
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal and Vaginal Cleansing; In the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section.	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.
Active Comparator: Abdominal Cleansing Alone; In the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing.	Procedure: Abdominal Cleansing; The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prespecified Stratified Analysis for Subgroups	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.	30 days postoperatively
Prespecified Stratified Analysis for Subgroups	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.	30 days postoperatively

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: June 28, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: cesarean section; wound infection; endometritis; vaginal cleansing
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 201505127