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

Columbia University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Surgical Site Infection; Cesarean Section; Infection

Treatments: Drug: Povidine-iodine; Drug: Chlorhexidine-alcohol; Drug: Sterile saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03640507

AAAR4891

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

Chlorhexidine-alcohol

Active Comparator group

Description:

Subjects will receive vaginal preparation with chlorhexidine-alcohol.

Treatment:

Drug: Chlorhexidine-alcohol

Povidine-iodine

Active Comparator group

Description:

Subjects will receive vaginal preparation with povidine-iodine.

Treatment:

Drug: Povidine-iodine

Saline

Placebo Comparator group

Description:

Subjects will receive vaginal preparation with sterile saline.

Treatment:

Drug: Sterile saline