NCT03640507

Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline

The Effect of Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline on Vaginal Bacteria Colony Counts in Pregnant Women

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cesarean Section; Infection
• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Chlorhexidine-alcohol	Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.
DRUG	Povidine-iodine	Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.
DRUG	Sterile saline	Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-05-08
• Completion: 2019-06-14
• First posted: 2018-08-21
• Last updated: 2020-06-09
• Results posted: 2020-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study