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Chlorhexidine Gluconate vs Povidone-Iodine Vaginal Cleansing Solution Prior to Cesarean Delivery

NCT02915289 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1114

Last updated 2018-09-14

No results posted yet for this study

Summary

Endometritis, an infection of the uterus in the postpartum period, has been shown to complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. Vaginal cleansing prior to cesarean delivery has been shown to minimize the presence of micro-organisms and risk of infection. Although povidone-iodine is the most commonly used anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's diminished efficacy in acidic vaginal pH and in the presence of blood. Chlorhexidine gluconate, on the other hand, has demonstrated superior disinfectant properties in several clinical trials, as compared to povidone iodine. In this randomized, comparator controlled, study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.

Conditions

  • Wound Infection
  • Complication, Postoperative

Interventions

PROCEDURE

Povidone Iodine

Vaginal preparation with 10% povidone iodine prior to non-emergent cesarean section.

PROCEDURE

Chlorhexidine gluconate

Vaginal preparation with 4% chlorhexidine gluconate prior to non-emergent cesarean section.

Sponsors & Collaborators

  • Richmond University Medical Center

    lead OTHER

Principal Investigators

  • Nisha Lakhi, MD · Richmond University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-04-30
Completion
2018-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02915289 on ClinicalTrials.gov