Recruitment

Recruitment Status
Completed
Estimated Enrollment
50

Inclusion Criterias

aged 18-48,
Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis,
English and or Spanish speaking, admitted in labor or undergoing induction of labor
...
aged 18-48,
Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis,
English and or Spanish speaking, admitted in labor or undergoing induction of labor
ability to give informed consent,

Exclusion Criterias

allergy to vancomycin
currently receiving antibiotics for another indication,
recent antibiotic use (within the previous 7 days),
...
allergy to vancomycin
currently receiving antibiotics for another indication,
recent antibiotic use (within the previous 7 days),
Inability to give consent,

Summary

Conditions
  • GBS Positive
  • Women in Labor Given Vancomycin for Prophylaxis
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 48 years
Gender
Only females

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 prophylaxi...

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.

Inclusion Criterias

aged 18-48,
Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis,
English and or Spanish speaking, admitted in labor or undergoing induction of labor
...
aged 18-48,
Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis,
English and or Spanish speaking, admitted in labor or undergoing induction of labor
ability to give informed consent,

Exclusion Criterias

allergy to vancomycin
currently receiving antibiotics for another indication,
recent antibiotic use (within the previous 7 days),
...
allergy to vancomycin
currently receiving antibiotics for another indication,
recent antibiotic use (within the previous 7 days),
Inability to give consent,

Locations

Providence, Rhode Island, 02905
Providence, Rhode Island, 02905

Tracking Information

NCT #
NCT02143154
Collaborators
Not Provided
Investigators
  • Principal Investigator: Maureen S Hamel, MD Warren Alpert Medical School of Brown University, Women & Infants Hospital of Rhode Island, Department of Obstetrics and Gynecology
  • Maureen S Hamel, MD Warren Alpert Medical School of Brown University, Women & Infants Hospital of Rhode Island, Department of Obstetrics and Gynecology