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

Phase 2

Completed

• Conditions: Cesarean Section; Infection; Surgical Site Infection
• Interventions: Drug: Chlorhexidine-alcohol; Drug: Povidine-iodine; Drug: Sterile saline

• Registration Number: NCT03640507
• Lead Sponsor: Columbia University

Brief 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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Start: 2018-10-01
• Primary Completion: 2019-05-08
• Study Completion: 2019-06-14
• Status Verified: 2020-05
• Results First Submitted: 2020-05-14
• Results First Submitted QC: 2020-05-29
• Last Update Submitted: 2020-05-29
• Results First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Pregnant women admitted for cesarean delivery
• Gestational age greater than or equal to 34 weeks

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine-alcohol	Chlorhexidine-alcohol	Subjects will receive vaginal preparation with chlorhexidine-alcohol.
Povidine-iodine	Povidine-iodine	Subjects will receive vaginal preparation with povidine-iodine.
Saline	Sterile saline	Subjects will receive vaginal preparation with sterile saline.

Primary Outcome Measures

Name	Time	Method
Post-intervention Aerobic Bacterial Colony Counts	From intervention to 7 days post	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.
Post-intervention Anaerobic Bacterial Colony Counts	From intervention to 7 days post	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.

Secondary Outcome Measures

Name	Time	Method
Baseline Anaerobic Bacterial Colony Counts	From intervention to 7 days post	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.
Baseline Aerobic Bacterial Colony Counts	From intervention to 7 days post	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.

Trial Locations

Locations (1)

New York Presbyterian Hospital at Columbia University and Children's Hospital of New York; 🇺🇸 New York, New York, United States