Clinical trial NCT02143154: Intrapartum Vancomycin for Group B Streptococcus (GBS) Prophylaxis
Official title: Intrapartum Vancomycin in GBS-positive Women: The Effect on Vaginal Group B Streptococcus Colony Counts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GBS Positive
Women in Labor Given Vancomycin for Prophylaxis
Keywords: vancomycin, GBS
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage decline in vaginal GBS colony counts
timeFrame: up to eight hours or delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
affiliation: Warren Alpert Medical School of Brown University, Women & Infants Hospital of Rhode Island, Department of Obstetrics and Gynecology
name: Maureen S Hamel, MD
role: PRINCIPAL_INVESTIGATOR
References: