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Early-onset Group B Streptococcal Disease Prevention: For Clinicians Overview of CDC Prevention Guidelines, 2010 National Center for Immunization and.

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Presentation on theme: "Early-onset Group B Streptococcal Disease Prevention: For Clinicians Overview of CDC Prevention Guidelines, 2010 National Center for Immunization and."— Presentation transcript:

1 Early-onset Group B Streptococcal Disease Prevention: For Clinicians Overview of CDC Prevention Guidelines, National Center for Immunization and Respiratory Diseases Division of Bacterial Diseases November 19, 2010 This presentation will provide an overview of early-onset Group B streptococcal disease prevention for Clinicians with a focus on CDC’s 2010 prevention guidelines Image: CDC logo (Centers for Disease Control and Prevention) and HHS logo (Department of Health and Human Services) National Center for Immunization & Respiratory Diseases Division of Bacterial Disease

2 Background on Group B Streptococcal (GBS) Disease and Prevention
This section will provide background on Group B streptococcal disease, also known as GBS disease, and prevention.

3 Group B Streptococcus Gram positive, beta hemolytic bacteria
Common colonizer of human gastrointestinal and genitourinary tracts Recognized as causing disease in humans in the 1930s Causes serious disease in young infants, pregnant women and older adults Emerged as most common cause of sepsis and meningitis in infants <3 months in the 1970s Group B Streptococcus Group B Streptococcus is a gram positive, beta hemolytic bacteria. It is a common colonizer of the human gastrointestinal and genitourinary tracts. It was first recognized as causing disease in humans in the 1930s. It can cause serious disease in young infants, pregnant women and older adults. It emerged as the most common cause of sepsis and meningitis in young infants in the 1970s

4 GBS Disease in Infants Before Prevention Efforts
Early-onset: 0-6 days of life Late onset: 7-89 days of life GBS Disease In Infants Before Prevention Efforts This slide shows the distribution of infant GBS disease by age of onset. The data are taken from a study that was summarized in a review by Schuchat and published in Clin Micro Rev in 1998, Volume 11, pages The data represent cases detected in the 1980s, before prevention efforts. Among infants under 90 days of age, the risk of GBS disease was not evenly distributed. The graph shows that 77.5% of GBS cases in infants were among those less than 1 week old. Cases occurring within the first week of life are called early-onset disease. Cases in infants 7-89 days of life are called late-onset. A Schuchat. Clin Micro Rev 1998;11:

5 Early-onset GBS Disease (EOGBS)
Leading infectious cause of neonatal sepsis in U.S. Annual incidence in 2008: 0.28 cases / 1,000 live births Estimated 1,200 cases in 2008 Clinical presentation Typically symptoms appear on day 0 or day 1 of life Respiratory distress, apnea, signs of sepsis most common symptoms Bacteremia most common form of disease (app. 80% of cases) Pneumonia and meningitis less common Case fatality rate 1970s: As high as 50% 4-6% in recent years Early-onset GBS Disease Early-onset GBS disease is the leading infectious cause of neonatal sepsis in the U.S. Early-onset GBS disease annually causes cases / 1,000 live births Early-onset GBS disease causes an estimated 1,200 cases of neonatal sepsis per year. Clinical presentation Typically symptoms appear on day 0 or day 1 of life Symptoms often include respiratory distress, apnea, signs of sepsis. Bacteremia most common form of Early-onset GBS disease (app. 80% of cases) Pneumonia and meningitis are less common forms of Early-onset GBS disease. Case fatality rate for Early-onset GBS disease 1970s: As high as 50% 4-6% in recent years

6 Photo courtesy of Dr. Carol Baker
NEONATAL GBS CLINICAL SLIDES This is one of two slides that demonstrates the potential severity of neonatal GBS disease. Here is an 18-hour-old-infant with GBS bacteremia and pneumonia. In this photo, the infant’s condition has stabilized, but the infant remains on mechanical ventilation and vasopressors. In cases of severe disease infants may require extracorporeal membrane oxygenation (ECMO), which is a temporizing, supportive treatment to effectively bypass severely diseased lungs while they are given time to heal from infection. Photo courtesy of Dr. Carol Baker, Baylor College of Medicine, Houston, TX Photo courtesy of Dr. Carol Baker Baylor College of Medicine, Houston, TX

7 NEONATAL GBS CLINICAL SLIDES
This slide shows the kind of vascular compromise that can result from GBS sepsis, with extensive purpura on the legs and perineum on this 2-day-old term male infant. This infant was born to a mother with no clinical risk factors for GBS; however, on the second day of life, the infant developed apnea, shock, disseminated intravascular coagulopathy (DIC) and peripheral gangrene and subsequently died. Photo courtesy of Dr. Carol Baker, Baylor College of Medicine, Houston, TX Photo courtesy of Dr. Carol Baker Baylor College of Medicine, Houston, TX

8 GBS Maternal Colonization
GBS Carriers 10% - 30% of women Higher proportion in African Americans and nonsmokers GBS usually live in gastrointestinal tract but can spread to the genital tract No symptoms or signs on examination Colonization comes and goes over months Not a sexually transmitted infection Risk factor for early-onset disease: GBS colonization during labor and delivery Prenatal cultures late in pregnancy can predict delivery status GBS MATERNAL COLONIZATION At any given time, between 10 and 30 percent of women are colonized with GBS. The rate is higher among African Americans and among nonsmokers. GBS usually live in the gastrointestinal tract but can spread to the genital tract. GBS colonization in the gastrointestinal and genital tracts of women is most often asymptomatic and does not require treatment. Since there are no clinical signs of colonization, you cannot tell who is a GBS carrier by doing a physical exam or taking a history. GBS colonization is a dynamic condition, GBS colonization may come and go over months. If a woman is colonized with GBS at one point in time that does not mean that she will be colonized several months later. This is important to recognize because prevention of GBS disease depends on identifying women who are likely to be colonized at the time of delivery. GBS not a sexually transmitted infection Maternal vaginal colonization with GBS at the time of labor and delivery is an important risk factor for neonatal early-onset disease. Prenatal cultures of samples taken from the vagina and rectum late in pregnancy can predict colonization status at delivery.

9 Mother to Infant Transmission of GBS
GBS colonized mother Non-colonized newborn 50% Colonized newborn Asymptomatic 98% Early-onset sepsis, pneumonia, meningitis 2% MATERNAL-TO-INFANT TRANSMISSION Most Group B Streptococcal Disease cases among newborns result from mother-to-infant transmission during labor and delivery. Many women are asymptomatically colonized by group B streptococcus in the genital and gastrointestinal tracts. Colonization is not altered by or dependent on pregnancy. About half the infants born to colonized mothers are themselves colonized on the skin and mucosal surfaces as a result of passage through the birth canal or as a result of GBS ascending into the amniotic fluid. The majority of colonized infants, 98%, are asymptomatic. About 2% will develop early-onset disease, presenting with sepsis, pneumonia or meningitis in the first few days of life.

10 Additional Risk Factors for Early-onset GBS Disease
Obstetric risk factors: Preterm delivery Prolonged rupture of membranes Infection of the placental tissues or amniotic fluid / fever during labor GBS in the mother’s urine during pregnancy (marker for heavy colonization) Previous infant with GBS disease Low maternal levels of anti-GBS antibodies Demographic risk factors African American Young maternal age ADDITIONAL RISK FACTORS FOR EARLY-ONSET GBS DISEASE There are certain other risk factors which increase the chance that an infant will be afflicted with the disease. Obstetric risk factors include preterm delivery (defined as delivery at less than 37 weeks), prolonged rupture of membranes (defined in various studies as more than 12, 18 or 24 hours), and infection of the placental tissues or amniotic fluid, which can manifest as a fever during labor. Other risk factors include symptomatic or asymptomatic GBS bacteriuria, having delivered a previous infant with GBS disease, immunologic risk factors such as a low level of antibody to GBS capsular polysaccharide, and demographic risk factors such as African-American race and young maternal age at delivery.

11 Prevention of Early-onset GBS Disease
Intrapartum antibiotics (IAP) Highly effective at preventing early-onset disease in women at risk of transmitting GBS to their newborns Efficacy in clinical trials: 100% Effectiveness in observational studies: 86-89% Challenge: How best to identify women who should receive IAP? PREVENTION OF PERINATAL GBS DISEASE In the 1980s, it was discovered that intrapartum antibiotics, abbreviated as IAP, are highly effective in preventing mothers at risk from transmitting GBS to their newborns. The efficacy in a clinical trial was 100% and in observational studies the effectiveness ranged from 86-89%. The challenge since this discovery has been how to best identify women who should receive IAP.

12 1996 Consensus Guidelines for GBS Prevention
Screening-based approach: Vaginal-rectal culture at wks IAP for GBS carriers IAP for preterm delivery (unless negative culture result available) Risk-based approach : No vaginal-rectal culture IAP for preterm deliveries, membrane rupture>18 hours, or intrapartum fever (T>38˚C) Both strategies - IAP to women with: GBS bacteriuria during pregnancy Previous infant with GBS disease 1996 Consensus Guidelines for GBS Prevention The 1996 Consensus Guidelines for GBS prevention outlined two approaches for identifying women in need of IAP. Screening-based approach: Vaginal-rectal culture at wks IAP for GBS carriers IAP for preterm delivery (unless negative culture result available) Risk-based approach : No vaginal-rectal culture IAP for preterm deliveries, membrane rupture>18 hours, or intrapartum fever (T>38C) Both strategies - IAP to women with: GBS bacteriuria during pregnancy Previous infant with GBS disease

13 Rate of Early- onset GBS Disease in the 1990s, United States
Group B Strep Association formed 1st ACOG & AAP statements CDC draft guidelines published Consensus guidelines RATE OF EARLY- AND LATE-ONSET GBS DISEASE IN THE 1990s, U.S. This slide plots the incidence of early-onset GBS disease in areas covered by the multi-state, population-based Active Bacterial Core surveillance system from 1989 to 2000. The white line represents early-onset GBS disease. The incidence of early-onset GBS disease in the United States since 1993 declined 70% (from 1.7 cases per 1,000 live births in 1993 to 0.45 cases per 1,000 live births in 1999) , coinciding with increased prevention activities. The graph shows that in 2000 the rates had plateaued at 0.5 cases per 1,000 live births. This graph was originally published by Schrag in New England Journal of Medicine, 2000, 342: Schrag, New Engl J Med : 15-20

14 Screening for GBS Protects More Infants from Early-onset GBS than Relying on Risk Factors
Infants whose mothers are screened for GBS are less than half as likely to develop early-onset GBS disease as mothers who are not screened Screening identifies colonized women without obstetric risk factors (18% of all deliveries in 1990s) Screening for GBS Protects More Infants from Early-onset GBS than Relying on Risk Factors Infants whose mothers are screened for GBS are less than half as likely to develop early-onset GBS disease as mothers who are not screened. Screening identifies colonized women without obstetric risk factors (18% of all deliveries in 1990s). These data were originally published by Schrag et al. in the New England Journal of Medicine, 2002, 347: Schrag et al, NEJM 2002, 347:233-9

15 2002 GBS Guidelines: Key Changes
Single strategy for identifying candidates for IAP: universal screening by culture at wks IAP agents for penicillin-allergic Cefazolin, except for women at high risk of anaphylaxis No routine IAP for planned cesarean deliveries GBS screening and IAP for threatened preterm deliveries More detail on specimen collection and handling Neonatal management Addition of chorioamnionitis 2002 Guidelines: Key Changes The early-onset GBS disease prevention guidelines were updated in 2002. Single strategy for identifying candidates for IAP: universal screening by culture at wks IAP agents for penicillin-allergic Ideally, cefazolin, except for women at high risk of anaphylaxis No routine IAP for planned cesarean deliveries GBS screening and IAP for threatened preterm deliveries More detail on specimen collection and handling Neonatal management Addition of chorioamnionitis

16 Implementation and Impact of Early-onset GBS Disease Prevention Guidelines
This section will cover the implementation and impact of early-onset GBS disease prevention guidelines.

17 Proportion of Women Screened for GBS Colonization
A multi-state retrospective cohort study was conducted to assess the implementation of the 2002 guidelines for preventing early-onset GBS disease. This study involved the review of ~7,600 L&D records from a sample of ~800,000 live births for The study indicated that 85% women were being screened for GBS colonization by This was a marked increase from the 48% of women screened in There was an increase in the proportion of individuals screened in all of the areas studied. 98% of the women screened had a GBS screening result available at labor However, when data from all groups was pooled, black and Hispanic women had a slightly lower rate of screening than women who were not black or Hispanic This graph was originally published by Van Dyke et al. in the New England Journal of Medicine, 2009, 360: Proportion of women screened increased from 48% to 85% 98% of women screened had available result at labor Van Dyke et al., NEJM :

18 Proportion of Women with an Indication for GBS IAP Who Received GBS IAP
The study on implementation of the 2002 guidelines for preventing early-onset GBS disease also indicated that 85% of women who had an indication for GBS IAP received it in This was a marked increase from the 74% of women who had an indication for GBS IAP and then received it in There was an increase in the proportion of individuals with an indication who received IAP in all of the areas studied. This graph was originally published by Van Dyke et al. in the New England Journal of Medicine, 2009, 360: Proportion of women with an indication for IAP who then received IAP increased from 74% to 85% Van Dyke et al., NEJM :

19 Rate of Early- and Late-Onset GBS, 1990-2008
Early-onset GBS Late-onset GBS RATE OF EARLY- AND LATE-ONSET GBS DISEASE , U.S. This graph plots the incidence of early-and late-onset GBS disease in the ABCs areas from 1989 to 2008. The yellow line represents late-onset disease in this graph. Even with the implementation of guidelines recommending GBS prophylaxis, late-onset GBS disease rates have remained stable since 1990 at approximately 0.3 cases per 1,000 live births. The white line represents early-onset disease. The incidence of early-onset GBS disease in the United States since 1993 has declined 84% (from 1.7 cases per 1,000 live births in 1993 to 0.28 cases per 1,000 live births in 2008) , coinciding with increased prevention activities. These data are from Active Bacterial Core surveillance, part of the CDC’s Emerging Infections Program. Before national prevention policy Transition Universal screening Source: Active Bacterial Core surveillance / Emerging Infections Program

20 Early-onset GBS Disease in the U.S., 2000-2008
Universal screening Early-onset GBS Disease in the US, This slide shows a graph plotting the incidence of early-onset GBS disease in the ABCs areas from 2000 to 2008. During this time period, there was a 46% decrease in early-onset GBS disease. The most notable decline was during , the year following the publication of revised early-onset GBS prevention guidelines. These data are from Active Bacterial Core surveillance, part of the CDC’s Emerging Infections Program. Source: Active Bacterial Core surveillance / Emerging Infections Program

21 Rate of Early-onset GBS Disease by Race and Gestational Age, 2000-2007
Universal screening Black <37 wks White <37 wks Some groups, particularly pre-term and black infants, remain disproportionately affected by early-onset GBS disease. This graph plots the incidence of early-onset invasive GBS disease in black neonates < 37 and ≥37 weeks gestational age and white neonates < 37 and ≥37 weeks gestational age in areas under surveillance through the Active Bacterial Core surveillance system. Between 2000 and 2007, rates of early-onset GBS disease decreased among both black (30% reduction) and white infants (49% reduction) born at ≥37 weeks gestational age However, between 2000 and 2007 rates among both black and white infants born at <37 weeks essentially remained the same or increased. Also, among infants born at a gestational age <37 weeks, rates of early-onset GBS disease were 3.8 times higher among black infants than among white infants These data are from Active Bacterial Core surveillance, part of the CDC’s Emerging Infections Program. Black >37 wks White >37 wks Source: Active Bacterial Core surveillance / Emerging Infections Program

22 Implementation Challenges
Missed prevention opportunities among infants born preterm 50% screened prior to admission Only 18% of GBS unknown screened on admission Preterm 20% less likely to receive IAP when indicated than term Receipt of ≥4 hours IAP protective (78% effective, 95% CI 44-91) Penicillin-allergic women Only 14% at low risk for anaphylaxis received cefazolin 70% at low risk for anaphylaxis received clindamycin even though <5% had susceptibility testing No data on efficacy/effectiveness of clindamycin to prevent EOGBS Implementation Challenges Missed prevention opportunities among infants born preterm 50% screened prior to admission 18% of GBS unknown screened on admission Preterm 20% less likely to receive IAP when indicated than term Receipt of ≥4 hours IAP protective (78% effective, 95% CI 44-91) Penicillin-allergic women Only 14% at low risk for anaphylaxis received cefazolin 70% at low risk for anaphylaxis received clindamycin even though <5% had susceptibility testing No data on efficacy/effectiveness of clindamycin to prevent EOGBS These data were originally published by Van Dyke in New England Journal of Medicine, 2009, 360: Van Dyke et al., N Engl J Med Jun 18;360(25):

23 GBS Resistance: Clindamycin and Erythromycin All Ages, 2001-2008*
47.7% 25.6% 24.8% 11.4% GBS Resistance: Clindamycin and Erythromycin for All Ages, The lack of erythromycin/clindamycin susceptibility testing is important because resistance among GBS isolates to clindamycin or erythromycin is a significant and growing problem. Resistance to clindamycin and erythromycin increased among GBS isolates between 2001 and 2008. The percent of isolates resistant to clindamycin increased from 11.4% n 2001 to 24.8% in 2008. The percent of isolates resistant to erythromycin increased from 25.6% n 2001 to 47.7% in 2008. These data are based on isolates from Colorado, Georgia, Maryland, Minnesota, New York, and Oregon data were excluded since only early-onset isolates were tested. These data are from Active Bacterial Core surveillance, part of the CDC’s Emerging Infections Program *Isolates are from CO, GA, MD, MN, NY, and OR data excluded since only early-onset isolates were tested. Source: Active Bacterial Core surveillance / Emerging Infections Program

24 Potential Unintended Consequences of GBS Prevention Guidelines
Adverse drug reactions Anaphylaxis among women receiving GBS IAP very rare Two studies reviewing >12,000 births found one non-fatal case Four published case reports in U.S. since 1996 Impact on non-GBS sepsis Stable or decreasing rates in most studies E.coli sepsis may be increasing among pre-term infants, but trends not consistent across studies Health services utilization for neonates Studies conducted during reported increased, stable, or decreased use of health services for neonates whose mothers received IAP No studies on the impact of the 2002 guidelines Potential Unintended Consequences of GBS Prevention Guidelines Adverse drug reactions Anaphylaxis among women receiving GBS IAP very rare. Two studies reviewing >12,000 births found one non-fatal case. Four published case reports in the U.S. since 1996. Impact on non-GBS sepsis Stable or decreasing rates in most studies. E.coli sepsis may be increasing among pre-term infants, but trends are not consistent across studies. Health services utilization for neonates Studies conducted during reported increased, stable, or decreased use of health services for neonates whose mothers received IAP. No studies have reported on the impact of the 2002 guidelines.

25 2010 GBS Guidelines Organizations Endorsing CDC’s 2010 GBS Guidelines
American College of Obstetricians and Gynecologists American Academy of Pediatrics American College of Nurse-Midwives American Academy of Family Physicians American Society for Microbiology Organizations Endorsing the 2010 GBS Guidelines American Congress of Obstetricians and Gynecologists American Academy of Pediatrics American College of Nurse-Midwives American Academy of Family Physicians American Society for Microbiology

26 2010 GBS Guidelines: Methods
Key stakeholders convened late 2008 American Academy of Pediatrics, American Academy of Family Physicians, American College of Nurse-midwives, American College of Obstetricians and Gynecologists, Centers for Disease Control and Prevention, Society for Hospital Epidemiology of America, American Society for Microbiology, microbiologists, pharmacologists, state health departments, parent organizations Reviewed relevant data Identified areas of guidelines that needed changes or clarifications Made evidence-based revisions to guidelines GBS Guidelines Revision In order to address the implementation challenges in the guidelines for preventing early-onset GBS disease, key stakeholders convened in late These included: American Academy of Pediatrics, American Academy of Family Physicians, American College of Nurse-Midwives, American College of Obstetricians and Gynecologists, Centers for Disease Control and Prevention, Society for Hospital Epidemiology of America, American Society for Microbiology, microbiologists, pharmacologists, state health departments, parent organizations Reviewed relevant data Published literature and ‘grey’ literature Data from on-going surveillance and research Identified areas of guidelines that needed changes or clarifications Made evidence-based revisions to guidelines

27 The Recommendations MMWR, Vol 59 (RR-10)
THE RECOMMENDATIONS: MMWR, VOLUME 59 (RR-10) This slide shows the front cover of the 2010 revised GBS prevention guidelines. The entire document has been published by MMWR in Volume 59, RR-10.

28 Key Prevention Strategies Remain Unchanged in 2010
Universal screening of pregnant women for GBS at weeks gestational age Intrapartum antibiotic prophylaxis for: GBS positive screening test GBS colonization status unknown with Delivery <37 weeks Temperature during labor >100.4˚ F (>38.0˚ C) Rupture of membranes >18 hours Previous infant with GBS disease GBS in the mother’s urine during current pregnancy Penicillin preferred drug for IAP Ampicillin acceptable alternative Cefazolin preferred for penicillin-allergic at low risk of anaphylaxis PREVENTION OF PERINATAL GBS DISEASE The key prevention strategies remain unchanged in the 2010 guidelines Universal screening of pregnant women at weeks gestational age. Women should later receive intrapartum antibiotic prophylaxis against GBS if they had: a GBS + screening culture; an unknown GBS colonization status with delivery before 37 weeks, a temperature during labor greater than or equal to 100.4˚F or 38.0˚C, or rupture of membranes for more than 18 hours; a previous infant with GBS disease; or GBS bacteriuria during the current pregnancy. Penicillin is the preferred drug for IAP, although ampicillin is an acceptable alternative. Cefazolin is the preferred option for penicillin allergic women with a low risk of anaphylaxis with penicillin. Nonetheless, there are important changes in the 2010 GBS guidelines. I will now review the key points that clinicians need to know about GBS prevention, highlighting areas of changes in 2010.

29 Identification of Candidates for IAP in the 2010 GBS Guidelines
This section will cover identification of candidates to receive IAP in the 2010 GBS prevention recommendations.

30 Indications for Intrapartum GBS Prophylaxis
Previous infant with invasive GBS disease GBS bacteriuria during current pregnancy Positive GBS screening test during current pregnancy Unknown GBS status AND any of the following: Delivery at <37 weeks’ gestation Amniotic membrane rupture 18 hours Intrapartum temperature 100.4°F ( 38.0 °C) Indications for IAP under universal prenatal screening Previous infant with invasive GBS disease GBS bacteriuria during any trimester of the current pregnancy Positive GBS screening test in late gestation during current pregnancy (unless a planned cesarean delivery, in the absence of labor or amniotic membrane rupture) Unknown GBS status AND any of the following: Delivery at <37 weeks’ gestation Amniotic membrane rupture 18 hours Intrapartum temperature 100.4°F ( 38.0 °C)

31 Intrapartum GBS Prophylaxis Not Indicated
Colonization with GBS during a previous pregnancy Unless another indication during the current pregnancy GBS bacteriuria during a previous pregnancy Negative vaginal and rectal GBS screening test during the current pregnancy Regardless of intrapartum risk factors Cesarean delivery performed before labor onset on a woman with intact amniotic membranes Regardless of maternal GBS test status Regardless of gestational age Intrapartum prophylaxis NOT indicated Colonization with GBS during a previous pregnancy Unless another indication during the current pregnancy GBS bacteriuria during a previous pregnancy Negative vaginal and rectal GBS screening test late in gestation during the current pregnancy Regardless of intrapartum risk factors Cesarean delivery performed before labor onset on a woman with intact amniotic membranes Regardless of maternal GBS test status Regardless of gestational age. The clarification that the recommendations for cesarean deliveries performed before labor onset on women with intact amniotic membranes apply to women delivering at any gestational age is new in the 2010 guidelines.

32 Bacteriuria GBS in urine during pregnancy
GBS found in urine of 2%-7% of pregnant women Marker of heavy vaginal-rectal colonization Risk factor for early-onset GBS disease in the newborn Antibiotic treatment of GBS bacteriuria during pregnancy does not eliminate GBS from the genitourinary and gastrointestinal tracts, and recolonization after a course of antibiotics is typical Clinicians must inform laboratories when submitted urine specimens are from pregnant women Women with symptomatic or asymptomatic GBS urinary tract infections detected during pregnancy should be treated according to current standards of care Women with GBS isolated from the urine at any time during the current pregnancy should receive IAP Bacteriuria GBS in urine during pregnancy GBS found in urine of 2%-7% of pregnant women. Marker of heavy vaginal-rectal colonization. Risk factor for early-onset GBS disease in the newborn. Antibiotic treatment of GBS bacteriuria during pregnancy does not eliminate GBS from the genitourinary and gastrointestinal tracts, and recolonization after a course of antibiotics is typical. Clinicians must inform laboratories when submitted urine specimens are from pregnant women. Women with symptomatic or asymptomatic GBS urinary tract infections detected during pregnancy should be treated according to current standards of care. Women with GBS isolated from the urine at any time during the current pregnancy should receive IAP.

33 Prenatal GBS Sample Collection
Site: vagina and rectum Single swab or two swabs Lower 1/3 of vagina Through anal sphincter Collection: NOT by speculum Self collection an option Timing: 35 to 37 weeks Transport: Nonnutritive transport medium Examples - Stuart’s or Amies With or without charcoal Results most sensitive if processed within 24 hours of collection Results most sensitive if refrigerated before processing CDC’S RECOMMENDATIONS FOR PRENATAL GBS CULTURES All women who do not have GBS bacteriuria during the current pregnancy or a previous infant with invasive GBS disease should undergo prenatal screening. Every effort should be made to optimize the yield from the tests. Includes sampling both the vagina and the rectum at the appropriate time. Sample collection can be done with either a single swab or with two swabs, but if two are used, both can go into a single nonnutritive transport medium. The vaginal swab should sample the lower one third of the vagina. Specimens should come from the lower third of the vagina, and the rectal swab should pass through the anal sphincter. Samples should NOT be collected with a speculum. Self-collected cultures from both vaginal and rectal sites can be an alternative to sample collected by clinicians, and patients may prefer to be offered this option. Samples should be collected during the 35th to 37th week of pregnancy. Specimens should be transported in a nonnutritive transport medium. Examples include Stuart’s or Amies medium with or without charcoal. Specimens in transport media will remain viable at room temperature for up to 4 days, however, Results are most sensitive when the sample is processed within 24 hours of collection. Results are most sensitive when the sample is refrigerated prior to processing.

34 Antimicrobial Susceptibility Testing for Penicillin-Allergic Women at High Risk of Anaphylaxis
Many isolates from invasive GBS disease are resistant to clindamycin or erythromycin Resistance to erythromycin is associated frequently but not always with resistance to clindamycin Some isolates susceptible to clindamycin but resistant to erythromycin may have inducible clindamycin resistance Antimicrobial susceptibility testing should be performed on antenatal GBS isolates from penicillin-allergic women at high risk for anaphylaxis Should include testing for inducible resistance (e.g. D-zone test) Specimens from penicillin allergic women at high risk for anaphylaxis should be clearly labeled Antibiotic susceptibility testing Many isolates from invasive GBS disease are resistant to clindamycin or erythromycin: Resistance to erythromycin is associated frequently but not always with resistance to clindamycin. Some isolates that are susceptible to clindamycin but resistant to erythromycin may have inducible clindamycin resistance Antimicrobial susceptibility testing should be performed on antenatal GBS isolates from penicillin-allergic women at high risk for anaphylaxis, and should include testing for inducible resistance (e.g. D-zone test). Specimens from penicillin allergic women at high risk for anaphylaxis should be clearly labeled as being from penicillin allergic women.

35 Intrapartum testing for GBS
Nucleic acid amplification tests (NAAT) such as PCR an option for intrapartum GBS testing for women who are GBS unknown at labor onset and have no risk factors Lower sensitivity for direct specimens (no enrichment) Positive result: Administer IAP Negative result and patient does not develop intrapartum temperature100.4°F ( 38.0 °C) or have ROM ≥18 hours: No IAP Negative result and patient develops intrapartum temperature 100.4°F ( 38.0 °C) or has ROM ≥18 hours: Administer IAP Additional slides on changes affecting laboratories in the 2010 GBS prevention guidelines can be found at: Intrapartum testing for GBS in 2010 guidelines Can do nucleic acid amplification tests (or NAAT) such as PCR for women who are GBS unknown at labor onset and have no risk factors Studies have found PCR for GBS to have a lower sensitivity when performed on direct specimens (no enrichment first) Positive result: Administer IAP Negative result and patient does not develop intrapartum fever or have ROM ≥18 hours: No IAP Negative result and patient develops intrapartum fever or has ROM ≥18 hours: Administer IAP Additional slides on changes affecting laboratories in the 2010 GBS prevention guidelines can be found at:

36 This slide shows an algorithm with many more choices for laboratory processing of prenatal specimens in the 2010 guidelines than in the 2002 guidelines. Additional slides on changes affecting laboratories in the 2010 GBS prevention guidelines can be found at:

37 Threatened Preterm Delivery
Separate algorithms are presented for GBS prophylaxis in the setting of threatened preterm delivery, one for spontaneous preterm labor (PTL) and one for preterm premature rupture of membranes (pPROM) Women with PTL or pPROM should all receive: Screening on admission for GBS if GBS status unknown Antibiotics for GBS prophylaxis Antibiotics to prolong latency in pPROM can serve as GBS IAP if certain criteria are met Ampicillin 2 g IV followed by 1 g IV every 6 hours for 48 hours Delivery occurs while the mother is receiving that antibiotic regime 2010 GBS Prevention Guidelines Changes: Obstetric Management Separate algorithms are presented for GBS prophylaxis in the setting of threatened preterm delivery, one for spontaneous preterm labor (PTL) and one for preterm premature rupture of membranes (pPROM). Women with PTL or pPROM should all receive: Screening on admission for GBS if GBS status unknown Antibiotics for GBS prophylaxis Antibiotics to prolong latency in pPROM can serve as GBS IAP if certain criteria are met. These criteria include: That the treatment is Ampicillin 2 g IV followed by 1 g IV every 6 hours for 48 hours and, The delivery occurs while the mother is receiving that antibiotic regime.

38 This slide shows algorithms for providing GBS intrapartum prophylaxis for women with preterm labor.

39 This slide shows algorithms for providing GBS intrapartum prophylaxis for women with preterm premature rupture of membranes.

40 Antibiotic Selection in the 2010 GBS Guidelines
This section will cover antibiotic selection in the 2010 GBS guidelines.

41 Antibiotics for IAP Penicillin the first-line agent for IAP
Dosage: 5 million IU IV then million IU IV every 4 hours Revised dose ( million IU) consistent with available penicillin formulations Ampicillin an acceptable alternative Antibiotics for intrapartum antibiotic prophylaxis Penicillin is the first-line agent for IAP. Recommended dose is 5 million IU IV then million IU IV every 4 hours Revised dose to be consistent with commercially available penicillin formulations and avoid need for pharmacies to specially mix doses Ampicillin is an acceptable alternative.

42 Data on Antibiotics for Intrapartum GBS Prophylaxis
Data from clinical trials, observational studies, and pharmacokinetics studies indicate that penicillin and ampicillin given as intrapartum prophylaxis are effective in preventing early-onset GBS disease. Data from observational and pharmacokinetics studies indicate that cefazolin is probably effective as GBS intrapartum prophylaxis. In contrast, there are no similar data available for clindamycin, erythromycin, or vancomycin.

43 Antibiotics for IAP in Women Allergic to Penicillin
Cefazolin best option for a woman allergic to penicillin but not at high risk for anaphylaxis Drugs with less evidence for effectiveness (e.g. clindamycin, vancomycin) only for women at high risk of anaphylaxis High risk for anaphylaxis defined as history of anaphylaxis, angioedema, respiratory distress or urticaria following penicillin Erythromycin no longer included as option Antibiotics for intrapartum antibiotic prophylaxis in penicillin-allergic women Ampicillin is an acceptable alternative. For women who are allergic to penicillin, cefazolin is the best option for a woman who is not at high risk for anaphylaxis Drugs with less evidence for effectiveness as GBS IAP, such as clindamycin and vancomycin, should only be used if a woman has a high risk of anaphylaxis to penicillin High risk for anaphylaxis is defined as a history of anaphylaxis, angioedema, respiratory distress, or urticaria following administration of a penicillin or a cephalosporin. Erythromycin is no longer included as an option in the 2010 GBS gudielines

44 Antibiotics for IAP in Women Allergic to Penicillin
Women at high risk for anaphylaxis following penicillin or a cephalosporin may receive CLINDAMYCIN for GBS IAP if: Their GBS isolate is susceptible to clindamycin and erythromycin OR Their GBS isolate is susceptible to clindamycin but resistant to erythromycin and testing for inducible resistance is negative Women at high risk for anaphylaxis following penicillin or a cephalosporin may receive VANCOMYCIN for GBS IAP if: Their GBS isolate is intrinsically resistant to clindamycin OR Their GBS isolate shows inducible resistance to clindamycin OR Their GBS isolate’s susceptibility to clindamycin and erythromycin is unknown Antibiotics for IAP in Penicillin Allergic Women: Modifications in 2010 Guidelines Women at high risk for anaphylaxis following penicillin or a cephalosporin may receive CLINDAMYCIN for GBS IAP if: Their GBS isolate is susceptible to clindamycin and erythromycin OR Their GBS isolate is susceptible to clindamycin but resistant to erythromycin and testing for inducible resistance is negative. Women at high risk for anaphylaxis following penicillin or a cephalosporin may receive VANCOMYCIN for GBS IAP if: Their GBS isolate is intrinsically resistant to clindamycin OR Their GBS isolate shows inducible resistance to clindamycin OR Their GBS isolate’s susceptibility to clindamycin and erythromycin is unknown

45 2010 GBS Guidelines: Algorithm for Selecting IAP Regimens
This slide shows an algorithm with recommended regimens for intrapartum antibiotic prophylaxis for prevention of early-onset GBS disease.

46 Newborn Management in the 2010 GBS Guidelines
This section will cover newborn management in the 2010 GBS guidelines.

47 Revised Neonatal Management Algorithm
Applies to all newborns Regardless of whether mother received IAP Management based on clinical appearance, risk factors (maternal chorioamnionitis, prolonged rupture of membranes, preterm), and adequacy of IAP if indicated for mother Adequate IAP clarified ≥4 hours of IV penicillin, ampicillin, or cefazolin before delivery All other agents or durations are considered inadequate for purposes of neonatal management Aims to reduce unnecessary evaluations and antibiotics in newborns at relatively low risk for early-onset GBS disease The revised neonatal management algorithm applies to all newborns, regardless of whether mother received IAP Management is based on clinical appearance, risk factors (maternal chorioamnionitis, prolonged rupture of membranes, preterm), and adequacy of IAP if indicated for mother The definition of adequate IAP is clarified as ≥4 hours of IV penicillin, ampicillin, or cefazolin before delivery. All other agents or durations are considered inadequate for purposes of neonatal management. This is because there are no data from clinical trials, observational studies, or pharmacokinetics studies available that show that intrapartum prophylaxis with other agents is effective in preventing early-onset GBS disease. In contrast, data are available for penicillin, ampicillin, and cefazolin indicating their effectiveness in preventing early-onset GBS disease. The revised algorithms aims to reduce unnecessary evaluations and antibiotics in newborns at relatively low risk for early-onset GBS disease

48 This slide shows an algorithm for the secondary prevention of early-onset GBS disease among newborns.

49 Recommended Management: 2002 vs. 2010
This slide explains how responses to various clinical scenarios differs between the 2002 and the 2010 guidelines. The 2002 guidelines offered no guidance on how to manage a newborn with signs of sepsis whose mother had not received IAP. The 2010 guidelines recommend that the infant receive antibiotics as well as a full diagnostic evaluation consisting of a complete blood count with differential and platelets, blood culture, chest radiograph (if respiratory abnormalities are present), and lumbar puncture (if the patient is stable enough to tolerate procedure and sepsis is suspected). Therapy for the infant should include antimicrobial agents active against GBS (including intravenous ampicillin) as well as other organisms that might cause neonatal sepsis, such as E.Coli. The 2002 guidelines offered no guidance on how to manage a well-appearing newborn whose mother had chorioamnionitis. The 2010 guidelines recommend that the infant receive a limited diagnostic evaluation consisting of a blood culture (at birth), and a complete blood count with differential and platelets as well as antibiotic treatment. The 2002 guidelines offered no guidance on how to manage a well-appearing newborn whose mother was GBS+ but did not receive IAP. The 2010 guidelines outline several options that depend on the infant’s gestational age and on how long the mother had rupture of membranes. The 2002 guidelines offered no guidance on how to manage a well-appearing newborn whose mother had an indication for IAP but received clindamycin or vancomycin. The 2010 guidelines outline several options that depend on the infant’s gestational age and on how long the mother had rupture of membranes. The 2002 guidelines recommended that all well-appearing newborns whose mothers had an indication for IAP and received less than 4 hours worth of ampicillin, penicillin, or cefazolin receive a limited diagnostic evaluation. The 2010 guidelines outline several options that depend on the infant’s gestational age and on how long the mother had rupture of membranes. The 2002 guidelines recommended that all well-appearing newborns born during the 35th or 36th week of pregnancy whose mothers had an indication for IAP and received at least 4 hours worth of ampicillin, penicillin, or cefazolin receive a limited diagnostic evaluation. The 2010 guidelines suggest that these infants do not routinely require diagnostic evaluations but should be observed for at least 48 hours.

50 What Can You Do to Help? Make sure your OB, Peds, FP, Midwife, and Microbiology colleagues know the new guidelines are out Check to see if your lab is following the new guidelines for laboratory methods Form a committee to plan steps needed for implementation in your facility What Can You Do to Help? Make sure your OB, Peds, Family Practice, Midwife, and Microbiology colleagues know the new guidelines are out. Check to see if your lab is following the new guidelines for laboratory methods. Form a committee to plan steps needed for implementation in your facility.

51 Early-onset GBS Disease Web Resources
Centers for Disease Control and Prevention American College of Obstetricians and Gynecologists American Academy of Pediatrics American College of Nurse-Midwives American Academy of Family Physicians American Society for Microbiology Group B Strep Association GBS WEB RESOURCES Listed on this slide are a few of the key resources available for the prevention of early-onset GBS disease. American Academy of Pediatrics, American College of Nurse-midwives, American College of Obstetricians and Gynecologists, American Society for Microbiology, Centers for Disease Control and Prevention, The Group B Strep Association (http://www.groupbstrep.org), a non-profit community-based organization, has a home page with linkages to both CDC and ACOG’s web sites, as well as other resources for parents.

52 Acknowledgments GBS Technical Team: Kathryn Arnold, Barbara Stoll, Yun Wang, Carol Baker, Carrie Byington, Richard Polin, Ronald Gibbs, Jeanne Jordan, Sarah Kilpatrick, Geraldine Hall, Tekoa King, Ruth Lynfield, Marti Perhach, Laura Riley, Pablo Sanchez, Pamela Simms, Julie Wood, Rex Astles, Bernard Beall, Roberta Carey, Janine Corey, Tarayn Fairlie, Lee Hampton, Denise Jamieson, Melissa Lewis, Lesley McGee, Michael Miller, Christine Olson, Alison Patti, Stephanie Schrag, Jennifer Verani, Emily Weston, Cynthia Whitney, Elizabeth Zell ACKNOWLEDGEMENTS GBS Technical Working Group: Kathryn Arnold, Barbara Stoll, Yun Wang, Carol Baker, Carrie Byington, Richard Polin, Ronald Gibbs, Jeanne Jordan, Sarah Kilpatrick, Geraldine Hall, Tekoa King, Ruth Lynfield, Marti Perhach, Laura Riley, Pablo Sanchez, Pamela Simms, Julie Wood, Rex Astles, Bernard Beall, Roberta Carey, Janine Corey, Tarayn Fairlie, Lee Hampton, Denise Jamieson, Lesley McGee, Melissa Lewis, Michael Miller, Christine Olson, Alison Patti, Stephanie Schrag, Jennifer Verani, Emily Weston, Cynthia Whitney, Elizabeth Zell

53 Image: CDC logo (Centers for Disease Control and Prevention) and HHS logo (Department of Health and Human Services) National Center for Immunization & Respiratory Diseases Division of Bacterial Disease


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