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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-06-14

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.

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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.

Conditions

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Cesarean Section; Infection Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Chlorhexidine-alcohol

Subjects will receive vaginal preparation with chlorhexidine-alcohol.

Group Type ACTIVE_COMPARATOR

Chlorhexidine-alcohol

Intervention Type DRUG

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

Povidine-iodine

Subjects will receive vaginal preparation with povidine-iodine.

Group Type ACTIVE_COMPARATOR

Povidine-iodine

Intervention Type DRUG

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

Saline

Subjects will receive vaginal preparation with sterile saline.

Group Type PLACEBO_COMPARATOR

Sterile saline

Intervention Type DRUG

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

Interventions

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Chlorhexidine-alcohol

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

Intervention Type DRUG

Povidine-iodine

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

Intervention Type DRUG

Sterile saline

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

Intervention Type DRUG

Other Intervention Names

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Chlorohexidine Gluconate (CHG) Betadine Sodium chloride 0.9%

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No