The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with saline alone.
This is a prospective trial of vaginal preparation (or vaginal cleansing/washing) on late preterm and term pregnancies admitted to Labor \& Delivery unit for cesarean delivery with three arms. Randomization allocation would be performed in 1:1:1 fashion for vaginal preparation with chlorhexidine-alcohol, povidine-iodine, and saline washes. A saline wash group is included to determine if the act of cleansing the vagina with a sponge alone reduces bacterial colony counts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
30
Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.
Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.
Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.
New York Presbyterian Hospital at Columbia University and Children's Hospital of New York
New York, New York, United States
Post-intervention Aerobic Bacterial Colony Counts
Vaginal cultures are collected after the vaginal preparation intervention. These undergo serial dilutions and are incubated on Tryptic Soy Agar for seven days. Bacteria colony counts were determined by blinded investigators on day 7.
Time frame: From intervention to 7 days post
Post-intervention Anaerobic Bacterial Colony Counts
Vaginal cultures are collected after the vaginal preparation intervention. These undergo serial dilutions and are incubated on Tryptic Soy Agar for seven days. Bacteria colony counts were determined by blinded investigators on day 7.
Time frame: From intervention to 7 days post
Baseline Aerobic Bacterial Colony Counts
Vaginal cultures are collected immediately prior to the vaginal preparation intervention. These undergo serial dilutions and are incubated on Tryptic Soy Agar for seven days. Bacteria colony counts were determined by blinded investigators on day 7.
Time frame: From intervention to 7 days post
Baseline Anaerobic Bacterial Colony Counts
Vaginal cultures are collected immediately prior to the vaginal preparation intervention. These undergo serial dilutions and are incubated on Tryptic Soy Agar for seven days. Bacteria colony counts were determined by blinded investigators on day 7.
Time frame: From intervention to 7 days post
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