Back to resultsVaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline
Primary Purpose
Cesarean Section; Infection, Surgical Site Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine-alcohol
Povidine-iodine
Sterile saline
Sponsored by
About this trial
This is an interventional basic science trial for Cesarean Section; Infection focused on measuring vaginal preparation, antisepsis, C-section
Eligibility Criteria
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
Sites / Locations
- New York Presbyterian Hospital at Columbia University and Children's Hospital of New York
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Chlorhexidine-alcohol
Povidine-iodine
Saline
Arm Description
Subjects will receive vaginal preparation with chlorhexidine-alcohol.
Subjects will receive vaginal preparation with povidine-iodine.
Subjects will receive vaginal preparation with sterile saline.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03640507
Brief Title
Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline
Official Title
The Effect of Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline on Vaginal Bacteria Colony Counts in Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
May 8, 2019 (Actual)
Study Completion Date
June 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section; Infection, Surgical Site Infection
Keywords
vaginal preparation, antisepsis, C-section
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine-alcohol
Arm Type
Active Comparator
Arm Description
Subjects will receive vaginal preparation with chlorhexidine-alcohol.
Arm Title
Povidine-iodine
Arm Type
Active Comparator
Arm Description
Subjects will receive vaginal preparation with povidine-iodine.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Subjects will receive vaginal preparation with sterile saline.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine-alcohol
Other Intervention Name(s)
Chlorohexidine Gluconate (CHG)
Intervention Description
Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.
Intervention Type
Drug
Intervention Name(s)
Povidine-iodine
Other Intervention Name(s)
Betadine
Intervention Description
Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.
Intervention Type
Drug
Intervention Name(s)
Sterile saline
Other Intervention Name(s)
Sodium chloride 0.9%
Intervention Description
Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.
Primary Outcome Measure Information:
Title
Post-intervention Aerobic Bacterial Colony Counts
Description
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
Title
Post-intervention Anaerobic Bacterial Colony Counts
Description
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
Secondary Outcome Measure Information:
Title
Baseline Aerobic Bacterial Colony Counts
Description
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
Title
Baseline Anaerobic Bacterial Colony Counts
Description
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
Other Pre-specified Outcome Measures:
Title
Number of Participants Diagnosed With Postpartum Infections.
Description
Chart review to assess any maternal infections diagnosed during postpartum hospitalization or at the time of the postpartum visit.
Time Frame
Up to six weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiping Han, PhD
Organizational Affiliation
Columbia University Department of Microbiology and Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital at Columbia University and Children's Hospital of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33345865
Citation
Duffy CR, Garcia-So J, Ajemian B, Gyamfi-Bannerman C, Han YW. A randomized trial of the bactericidal effects of chlorhexidine vs povidone-iodine vaginal preparation. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100114. doi: 10.1016/j.ajogmf.2020.100114. Epub 2020 Apr 15.
Results Reference
derived
PubMed Identifier
32335895
Citation
Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Results Reference
derived
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Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline
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