Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Group B Streptococcal Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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IV Vancomycin

GBS positive laboring women who are allergic to penicillin and clindamycin and are treated using IV vancomycin.

Vaginal and rectovaginal swab cultures

Intervention Type BIOLOGICAL

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.

Vaginal and rectovaginal swab cultures

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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

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

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes