Background
Cesarean delivery is the most performed major surgery among women, and surgical-site
infections following a cesarean delivery are a significant source of postoperative
morbidity. It is unclear if vaginal cleansing before a cesarean delivery decreases
post-cesarean delivery infectious morbidity.
Objective
This study aimed to evaluate if preoperative vaginal cleansing with povidone-iodine
among women undergoing a cesarean delivery after labor decreases postoperative infectious
morbidity.
Study Design
This randomized clinical trial was conducted from August 3, 2015 to January 28, 2021,
with 30 days of follow-up and the final follow-up completed on February 27, 2021.
Patients met the inclusion criteria if they underwent a cesarean delivery after regular
contractions with cervical dilation, rupture of membranes, or any cesarean delivery
performed at >4 cm dilation. Participants were randomly assigned in a 1:1 ratio to
either abdominal cleansing plus vaginal cleansing with 1% povidone-iodine or abdominal
cleansing alone. The primary outcome was composite infectious morbidity including
surgical-site infection, fever, endometritis, and wound complications within 30 days
after the cesarean delivery. Secondary outcomes included individual components of
the composite, length of hospital stay, postoperative hospitalization or outpatient
treatment related to infectious morbidity, and empirical treatment for neonatal sepsis.
Results
A total of 608 subjects (304 vaginal cleansing group, 304 control group) were included
in the intention-to-treat analysis. Patient characteristics were similar between groups.
There was no significant difference in the primary composite outcome between the 2
groups (11.8% vs 11.5%; P=.90; relative risk, 1.0; 95% confidence interval, 0.7–1.6). Individual components
of the composite and secondary outcomes were also not significantly different between
the groups. Similar findings were observed in the as-treated analysis (11.3% vs 11.8%;
P=.9; relative risk, 1.0; 95% confidence interval, 0.7–1.6).
Conclusion
Vaginal cleansing with povidone-iodine before an unscheduled cesarean delivery occurring
after labor did not reduce the postoperative infectious morbidity. These findings
do not support the routine use of vaginal cleansing for women undergoing a cesarean
delivery after labor.
Key words
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Article info
Publication history
Published online: November 29, 2022
Accepted:
November 28,
2022
Received in revised form:
November 10,
2022
Received:
August 26,
2022
Publication stage
In Press Journal Pre-ProofFootnotes
L.A.T. was supported by a National Institutes of Health (NIH) T32 training grant under grant number 5T32HD055172-07. This publication was also made possible by a grant from the NIH National Center for Advancing Translational Sciences (NCATS) under grant number UL1 TR000448, components of the NIH, and the NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the NIH. The authors report no other conflict of interest.
This study was presented at the 42nd annual pregnancy meeting of the Society for Maternal-Fetal Medicine, held virtually, January 31–February 5, 2022.
This study was registered with ClinicalTrials.gov under identifier NCT02495753 on July 13, 2015, and first enrollment was on August 1, 2015. URL of registration: https://clinicaltrials.gov/ct2/show/NCT02495753
Data sharing questions
a) Data available: Yes
b) Data types: deidentified participant data
c) How to access data: email: [email protected]
d) When available: beginning date: 09-01-2027
e) Supporting documents
f) Document types: none
g) Additional information
h) Who can access the data: researchers whose proposed use of the
data has been approved
i) Types of analyses: for a specified purpose
j) Mechanisms of data availability: after approval of a proposal
Cite this article as: Temming LA, Frolova AI, Raghuraman N, et al. Vaginal cleansing before unscheduled cesarean delivery to reduce infection: a randomized clinical trial. Am J Obstet Gynecol 2022;XX:x.ex–x.ex.
Identification
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