TerminatedNot Applicable

Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization

Stopped: Ancef (Cefazolin) became the new standard of care (instead of Vancomycin) for GBS prophylaxis if the patient is allergic to penicillin.

United States41 participantsStarted 2016-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

GBS colonization levels after admission to labor and delivery

Timeframe: At 8 hours

Trial details

NCT IDNCT02814318

SponsorTriHealth Inc.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-10

View on ClinicalTrials.gov More Group B Streptococcal Infection trials