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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03640507
Other study ID # AAAR4891
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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