Vaginal Cleansing Before Cesarean Delivery to Reduce Infection
1 other identifier
interventional
608
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2015
CompletedFirst Posted
Study publicly available on registry
July 13, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedAugust 6, 2021
August 1, 2021
5.4 years
June 28, 2015
August 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Adverse Reaction to Vaginal Cleansing
30 days postoperatively
Length of Hospital Stay
30 days postoperatively
Number of readmissions to hospital for infectious morbidity.
30 days postoperatively
Treatment for neonatal Sepsis
30 days postoperatively
Number of outpatient visits for infectious morbidiy.
30 days postoperatively.
Other Outcomes (2)
Prespecified Stratified Analysis for Subgroups
30 days postoperatively
Prespecified Stratified Analysis for Subgroups
30 days postoperatively
Study Arms (2)
Abdominal and Vaginal Cleansing
EXPERIMENTALIn the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section.
Abdominal Cleansing Alone
ACTIVE COMPARATORIn the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing.
Interventions
The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.
The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.
Eligibility Criteria
You may qualify if:
- Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.
You may not qualify if:
- Inability to obtain consent
- known or suspected allergy to iodine or shellfish
- women with active herpes simplex virus infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Related Publications (2)
Temming LA, Frolova AI, Raghuraman N, Tuuli MG, Cahill AG. Vaginal cleansing before unscheduled cesarean delivery to reduce infection: a randomized clinical trial. Am J Obstet Gynecol. 2023 Jun;228(6):739.e1-739.e14. doi: 10.1016/j.ajog.2022.11.1300. Epub 2022 Nov 30.
PMID: 36462539DERIVEDHaas 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.
PMID: 32335895DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2015
First Posted
July 13, 2015
Study Start
August 1, 2015
Primary Completion
January 1, 2021
Study Completion
April 1, 2021
Last Updated
August 6, 2021
Record last verified: 2021-08