Overview

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