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 range18 Years – 48 Years

SexFEMALE

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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

What they're measuring

Percentage decline in vaginal GBS colony counts

Timeframe: up to eight hours or delivery

Trial details

NCT IDNCT02143154

SponsorWomen and Infants Hospital of Rhode Island

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-10-03

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