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

• Status: Completed
• Trial end date: 2019-06-14
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Cadexomer iodine; Chlorhexidine; Chlorhexidine gluconate; Ethanol; Iodine; Povidone-Iodine

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