Vaginal Cleansing Before Cesarean Delivery to Reduce Infection

Complications; Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495753
• Other study ID #: 201505127
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: April 2021

Study information

• Verified date: August 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 608
• Est. completion date: April 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Complications; Cesarean Section
• Infection

Intervention

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.
• Abdominal Cleansing
The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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