Intrapartum Vancomycin for Group B Streptococcus (GBS) Prophylaxis (NCT02143154) | Clinical Trial Compass
CompletedNot Applicable
Intrapartum Vancomycin for Group B Streptococcus (GBS) Prophylaxis
United States77 participantsStarted 2014-10
Plain-language summary
While it is clear that intrapartum antibiotics reduce neonatal GBS infection rates, the mechanism by which these drugs prevent neonatal GBS is not well established. One postulated theory is antibiotics work to reduce bacterial load in the birth canal; thus decreasing fetal exposure during labor and delivery. To our knowledge, the relationship between vancomycin and vaginal GBS colony counts has never been studied. In this prospective cohort study, our objective is to determine the relationship between intrapartum IV vancomycin and vaginal GBS colony counts.
Who can participate
Age range
18 Years – 48 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.
Inclusion Criteria:
* Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis,
* ability to give informed consent,
* aged 18-48,
* English and or Spanish speaking, admitted in labor or undergoing induction of labor
Exclusion Criteria:
* Inability to give consent,
* currently receiving antibiotics for another indication,
* recent antibiotic use (within the previous 7 days),
* allergy to vancomycin
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.