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

NCT03640507 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-06-09

Study results available
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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.

Conditions

  • Cesarean Section; Infection
  • Surgical Site Infection

Interventions

DRUG

Sterile saline

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

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.

Sponsors & Collaborators

Principal Investigators

  • Yiping Han, PhD · Columbia University Department of Microbiology and Immunology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-05-08
Completion
2019-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640507 on ClinicalTrials.gov