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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640507
• Other study ID #: AAAR4891
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 1, 2018
• Est. completion date: June 14, 2019

Study information

• Verified date: May 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cesarean Section; Infection
• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Chlorhexidine-alcohol
Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.
• Povidine-iodine
Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.
• Sterile saline
Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital at Columbia University and Children's Hospital of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

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