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Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization

NCT02814318 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2020-04-06

No results posted yet for this study

Summary

The aim of this project is to identify the duration of vancomycin administration at which group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal mucosa. This will aid in labor management and delivery planning to ensure that the mother receives adequate GBS prophylaxis while also minimizing the duration of exposure to vancomycin. In addition, this could prevent unnecessary prolonged hospitalization or septic workup of neonates whose mothers received vancomycin intrapartum.

This study aims to identify the time after administration of IV vancomycin at which GBS colonies are 100% eradicated.

Conditions

  • Group B Streptococcal Infection

Interventions

BIOLOGICAL

Vaginal and rectovaginal swab cultures

The only intervention that will occur in this study is obtaining vaginal and recto-vaginal swab cultures upon admission to the labor and delivery room and every two hours to follow until 8 hours after administration of IV vancomycin or IV penicillin.

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Principal Investigators

  • William Kim Brady, MD · TriHealth Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-10-31
Completion
2019-10-31

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 NCT02814318 on ClinicalTrials.gov