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Completed

NCT Number: NCT03640507

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

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.

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Key information

Conditions

Cesarean Section; Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

New York Presbyterian Hospital at Columbia University and Children's Hospital of New York

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine-Alcohol

Drug

Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.

Other names: Chlorohexidine Gluconate (CHG)

Povidine-iodine

Drug

Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.

Other names: Betadine

Sterile Saline

Drug

Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.

Other names: Sodium chloride 0.9%

Primary outcomes

  1. Post-intervention Aerobic Bacterial Colony Counts

    Time frame: 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.

  2. Post-intervention Anaerobic Bacterial Colony Counts

    Time frame: 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 outcomes

  1. Baseline Aerobic Bacterial Colony Counts

    Time frame: 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.

  2. Baseline Anaerobic Bacterial Colony Counts

    Time frame: 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.

Other outcomes

  1. Number of Participants Diagnosed With Postpartum Infections.

    Time frame: Up to six weeks postpartum

    Chart review to assess any maternal infections diagnosed during postpartum hospitalization or at the time of the postpartum visit.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

The Effect of Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline on Vaginal Bacteria Colony Counts in Pregnant Women

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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