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Trial record 65 of 528 for:    VANCOMYCIN

Intrapartum Vancomycin for Group B Streptococcus (GBS) Prophylaxis

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ClinicalTrials.gov Identifier: NCT02143154
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Women and Infants Hospital of Rhode Island

Brief 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.

Condition or disease
GBS Positive Women in Labor Given Vancomycin for Prophylaxis

Detailed Description:

Charts of patients presenting for induction of labor will be reviewed for potential eligibility. After provider permission, eligible patients will be approached for screening who are presenting for induction with documented GBS positivity and plan for vancomycin for intrapartum antibiotic prophylaxis. Patients presenting to the emergency room for labor evaluation/labor evaluation/pre-term labor evaluation, may be pre-screened for potential eligibility. Patients subsequently admitted in labor/preterm labor or with rupture of membranes with documented GBS positivity and plan for vancomycin for intrapartum antibiotic prophylaxis will be approached for screening. Additionally pharmacy will alert study staff when a patient is admitted to the labor floor or antenatal care unit and vancomycin has been ordered for antibiotic prophylaxis. These patients will then be approached for screening

Data collection: Demographic information such as age, race, date of initial GBS culture and time of rupture of membranes will be abstracted from enrolled patients' charts. Intrapartum vaginal cultures will be collected with a vaginal swab from the distal vagina by trained obstetrics and gynecology residents, attendings, nurses, nurse midwives and nurse practitioners prior to the initiation of antibiotics and at two hour intervals until delivery or after eight hours has elapsed.

Swabs will be transported to the lab. Colony counts will be determined via serial dilution. Specimens will be diluted in sterile saline and inoculated onto Columbia Agar containing 5% sheep blood, colistin (10 mg), and nalidixic acid (10 mg/L). After incubation for 48 hours at 35 C in ambient air, the number of colonies on the dilution plates will be visually counted and multiplied by the appropriate dilution factor for that particular plate.


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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intrapartum Vancomycin in GBS-positive Women: The Effect on Vaginal Group B Streptococcus Colony Counts
Study Start Date : October 2014
Actual Primary Completion Date : October 3, 2018
Actual Study Completion Date : October 3, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
GBS positive women
Women wih GBS positive bacteruria with plan for treatment with vancomycin in labor, or women with positive GBS screening cultures with a plan to receive vancomycin in labor



Primary Outcome Measures :
  1. Percentage decline in vaginal GBS colony counts [ Time Frame: up to eight hours or delivery ]

Biospecimen Retention:   None Retained
vaginal swabs collected during labor plated for GGBS bacteria and then discarded


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143154


Locations
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United States, Rhode Island
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
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Principal Investigator: Maureen S Hamel, MD Warren Alpert Medical School of Brown University, Women & Infants Hospital of Rhode Island, Department of Obstetrics and Gynecology

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Responsible Party: Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT02143154     History of Changes
Other Study ID Numbers: Vancomycin for Group B Strept
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Women and Infants Hospital of Rhode Island:
vancomycin, GBS
Additional relevant MeSH terms:
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Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents