Surgical Site Infection Clinical Trial
Official title:
The Effect of Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline on Vaginal Bacteria Colony Counts in Pregnant Women
Verified date | May 2020 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 14, 2019 |
Est. primary completion date | May 8, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | New York Presbyterian Hospital at Columbia University and Children's Hospital of New York | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants Diagnosed With Postpartum Infections. | Chart review to assess any maternal infections diagnosed during postpartum hospitalization or at the time of the postpartum visit. | Up to six weeks postpartum | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
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