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

May 29, 2020 updated by: Yiping Weng Han, Columbia University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital at Columbia University and Children's Hospital of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Intervention Group (vaginal preparation)

Inclusion Criteria:

  • Pregnant women admitted for cesarean delivery
  • Gestational age greater than or equal to 34 weeks

Exclusion Criteria:

  • Rupture of membranes or active labor
  • Chorioamnionitis (prior to enrollment)
  • Recent (within 4 weeks) antibiotic exposure
  • Maternal HIV infection or immunocompromised state
  • Known allergy to shellfish, iodine, or chlorhexidine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chlorhexidine-alcohol
Subjects will receive vaginal preparation with chlorhexidine-alcohol.
Drug: Chlorhexidine-alcohol
Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.
Other Names:
  • Chlorohexidine Gluconate (CHG)
Active Comparator: Povidine-iodine
Subjects will receive vaginal preparation with povidine-iodine.
Drug: Povidine-iodine
Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.
Other Names:
  • Betadine
Placebo Comparator: Saline
Subjects will receive vaginal preparation with sterile saline.
Drug: Sterile saline
Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.
Other Names:
  • Sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-intervention Aerobic Bacterial Colony Counts
Time Frame: From intervention to 7 days post
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.
From intervention to 7 days post
Post-intervention Anaerobic Bacterial Colony Counts
Time Frame: From intervention to 7 days post
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.
From intervention to 7 days post

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Aerobic Bacterial Colony Counts
Time Frame: From intervention to 7 days post
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.
From intervention to 7 days post
Baseline Anaerobic Bacterial Colony Counts
Time Frame: From intervention to 7 days post
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.
From intervention to 7 days post

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Diagnosed With Postpartum Infections.
Time Frame: Up to six weeks postpartum
Chart review to assess any maternal infections diagnosed during postpartum hospitalization or at the time of the postpartum visit.
Up to six weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Yiping Han, PhD, Columbia University Department of Microbiology and Immunology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

May 8, 2019

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR4891

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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