CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Chlorhexidine-alcohol +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03640507
NCT03640507Phase 3Completed

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

Columbia University·interventional·Posted Aug 21, 2018·Updated Jun 9, 2020

In Brief

A Phase 3 clinical trial evaluating Chlorhexidine-alcohol, Povidine-iodine, and 1 other intervention for Cesarean Section; Infection and Surgical Site Infection. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 21, 2018
Enrollment StartOct 1, 2018
Primary CompletionMay 8, 2019
Study CompletionJun 14, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.9 years ago

Interventions

Chlorhexidine-alcoholdrug

Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.

Povidine-iodinedrug

Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.

Sterile salinedrug

Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.