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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cesarean Section; Infection, Surgical Site Infection

Intervention / Treatment
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* Drug: Chlorhexidine-alcohol
* Drug: Povidine-iodine
* Drug: Sterile saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From intervention to 7 days post | 
| 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. | From intervention to 7 days post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From intervention to 7 days post | 
| 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. | From intervention to 7 days post | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal preparation, antisepsis, C-section