Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization

April 2, 2020 updated by: TriHealth Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Prophylaxis of group B streptococcus has been a major component of prenatal care in preventing early onset of neonatal sepsis. While penicillin remains the gold standard medication for prophylaxis, this medication is not an option in women who have high risk allergic reactions to this class of medications. Furthermore, with rising rates of antibiotic resistance to erythromycin and clindamycin, more women are requiring vancomycin for GBS prophylaxis. While the CDC and ACOG recommend vancomycin as an alternative to penicillin for GBS prophylaxis, little research has been conducted investigating the transplacental passage of vancomycin.

Because of the gap in knowledge regarding intrapartum effects of IV vancomycin on GBS colonization, neonates of women who received vancomycin are considered as inadequately treated for GBS prophylaxis, and subsequently undergo additional observation, prolonged hospitalization, and possible septic workup in the immediate postpartum period. Because of this gap in knowledge, this research study investigates how quickly vaginal and recto-vaginal GBS colonization is eradicated to aid in timing of delivery in patients with GBS colonization who require vancomycin intrapartum.

In addition, the studies that investigated the duration of time of IV penicillin and IV clindamycin necessary for eradication of GBS colonization only investigated vaginal colonization, not recto-vaginal colonization. Their rationale was based on the assumption that most cases of neonatal GBS sepsis are caused by vaginal colonization. Given that the standard of care for GBS screening includes screening for colonization of both vaginal and rectal mucosa, investigators also plan to compare rates of eradication of GBS in vaginal colonies compared to recto-vaginal colonies.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

GBS positive laboring women aged at least 18 years old with pregnancies of 37 weeks gestational age or greater.

Description

Vancomycin Arm

Inclusion Criteria

  • Women aged 18 years or older
  • Pregnancies of at least 37w0d gestation at delivery
  • History of high-risk allergy to penicillin (including pruritic rash, urticaria, swelling, anaphylaxis)
  • Women who are GBS positive
  • Culture proven resistance or
  • Unknown resistance to clindamycin or erythromycin

Exclusion Criteria

  • Women with low risk allergy to penicillin
  • History of allergy to vancomycin
  • History of Red Man Syndrome
  • History of renal or hepatic disease
  • Immunocompromised patients
  • History of chronic steroid use in current pregnancy
  • Patient with fever or signs of chorioamnionitis on admission

Penicillin Arm

Inclusion Criteria

  • Women aged 18 years or older
  • Women who are GBS positive
  • Pregnancies of at least 37w0d gestation at delivery

Exclusion Criteria

  • Immunocompromised patients
  • History of chronic steroid use in current pregnancy
  • Patient with fever or signs of chorioamnionitis on admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IV Vancomycin
GBS positive laboring women who are allergic to penicillin and clindamycin and are treated using IV vancomycin.
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.
IV Penicillin
GBS positive laboring women who are not allergic to penicillin and are treated using IV penicillin.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GBS colonization levels after admission to labor and delivery
Time Frame: At 8 hours
At 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Investigators

  • Principal Investigator: William Kim Brady, MD, TriHealth Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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