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MS WordPerinatologist Corner - C.E.U/C.M.E. Modules
Group B Streptococcal Disease in the Perinatal Period
Sponsored by The Indian Health Service Clinical Support Center
5. The 2002 CDC Recommendations: categorized by strength of evidence
(All CDC recommendations should be followed: review this table for strength of evidence only)
Category A
Strong evidence for efficacy and substantial clinical benefit
Level I
Evidence from at least one well designed randomized controlled trial
- An alternative regimen is ampicillin, 2 g intravenously initial dose, then 1 g intravenously every 4 hours until delivery.
Level II
Based on non-randomized well designed studies, e.g., cohort or case control
- All pregnant women should be screened at 35-37 weeks gestation for vaginal and rectal GBS colonization. At the time of labor or rupture of membranes, intrapartum chemoprophylaxis should be given to all pregnant women identified as GBS carriers. Colonization during a previous pregnancy is not an indication for intrapartum prophylaxis in subsequent deliveries. Screening to detect GBS colonization in each pregnancy will determine the need for prophylaxis in that pregnancy.
- The risk-based approach is no longer an acceptable alternative except for circumstances in which screening results are not available before delivery
- If the result of GBS culture is not known at the onset of labor, intrapartum chemoprophylaxis should be administered to women with any of the following risk factors: gestation <37 weeks, duration of membrane rupture >18 hours, or a temperature of >100.4º F (>38.0ºC). Women with known negative results from vaginal and rectal GBS screening cultures within 5 weeks of delivery do not require prophylaxis to prevent GBS disease even if any of the intrapartum risk factors develop.
- Specimens should be inoculated into a selective broth medium (examples of appropriate commercially available media include Trans-Vag Broth supplemented with 5% defibrinated sheep blood or LIM broth), incubated overnight, and subcultured onto solid blood agar medium. Methods of testing prenatal isolates from penicillin-allergic women for susceptibility to clindamycin and erythromycin are outlined (Box 1). Laboratories should report culture results (positive and negative) and susceptibility testing results to the anticipated site of delivery (when known) and to the health-care provider who ordered the test.
- For intrapartum chemoprophylaxis, the following regimen is recommended for women without penicillin allergy (Box 2): penicillin G, 5 million units intravenously initial dose, then 2.5 million units intravenously every 4 hours until delivery. Because of its narrow spectrum of activity, penicillin is the preferred agent.
Category B
Strong or moderate evidence for efficacy, but limited clinical benefit
Level II
Based on non-randomized well designed studies, e.g., cohort or case control
- Women with GBS isolated from the urine in any concentration (e.g., 103) during their current pregnancy should receive intrapartum chemoprophylaxis because such women usually are heavily colonized with GBS and are at increased risk of delivering an infant with early-onset GBS disease. Labels on urine specimens from prenatal patients should clearly state the patient's pregnancy status to assist laboratory processing and reporting of results. Prenatal culture-based screening at 35--37 weeks' gestation is not necessary for women with GBS bacteriuria. Women with symptomatic or asymptomatic GBS urinary tract infection detected during pregnancy should be treated according to current standards of care for urinary tract infection during pregnancy.
- Women who have previously given birth to an infant with invasive GBS disease should receive intrapartum chemoprophylaxis; prenatal culture-based screening is not necessary for these women.
- Culture techniques that maximize the likelihood of GBS recovery are required for prenatal screening (Box 1). Collection of specimens for culture may be conducted in the outpatient clinic setting by either the patient, with appropriate instruction, or health-care provider. This involves swabbing the lower vagina and rectum (i.e., through the anal sphincter). Because lower vaginal as opposed to cervical cultures are recommended, cultures should not be collected by speculum examination. Specimens should be placed in a nonnutritive transport medium (e.g., Amies or Stuart's without charcoal). Specimen labels should clearly identify that specimens are for group B streptococcal culture. If susceptibility testing is ordered for penicillin-allergic women (Box 2), specimen labels should also identify the patient as penicillin allergic and should specify that if GBS is isolated, it should be tested for susceptibility to clindamycin and erythromycin.
Level III
Evidence from descriptive studies, expert panels or consensus
- Intrapartum chemoprophylaxis for penicillin-allergic women takes into account increasing resistance to clindamycin and erythromycin among GBS isolates (Box 2). During prenatal care, history of penicillin allergy should be assessed to determine whether a patient is at high risk for anaphylaxis, i.e., has a history of immediate hyper-sensitivity reactions to penicillin (e.g., anaphylaxis, angioedema, or urticaria) or history of asthma or other conditions that would make anaphylaxis more dangerous (89). Women who are not at high risk for anaphylaxis should be given cefazolin, 2 g intravenously initial dose, then 1 g intravenously every 8 hours until delivery.
Category C
Insufficient evidence for efficacy, or efficacy does not outweigh possible adverse consequences
Level II
Based on non-randomized well designed studies, e.g., cohort or case control
- GBS-colonized women who have a planned cesarean delivery performed before rupture of membranes and onset of labor are at low risk for having an infant with early-onset GBS disease. These women should not routinely receive intrapartum chemoprophylaxis for perinatal GBS disease prevention.
Level III
Evidence from descriptive studies, expert panels or consensus
- Women with threatened preterm (<37 weeks' gestation) delivery should be assessed for need for intrapartum prophylaxis to prevent perinatal GBS disease. An algorithm for management of women with threatened preterm delivery is provided. Other management approaches, developed by individual physicians or institutions, may be appropriate.
- For women at high risk for anaphylaxis, clindamycin and erythromycin susceptibility testing, if available, should be performed on isolates obtained during GBS prenatal carriage screening. Women with clindamycin- and erythromycin-susceptible isolates should be given either clindamycin, 900 mg intravenously every 8 hours until delivery; OR erythromycin, 500 mg intravenously every 6 hours until delivery. If susceptibility testing is not possible, susceptibility results are not known, or isolates are resistant to erythromycin or clindamycin, the following regimen can be used for women with immediate penicillin hypersensitivity: vancomycin, 1 g intravenously every 12 hours until delivery.
- Routine use of antimicrobial prophylaxis for newborns whose mothers received intrapartum chemoprophylaxis for GBS infection is not recommended. However, therapeutic use of these agents is appropriate for infants with clinically suspected sepsis. An updated algorithm for management of infants born to mothers who received intrapartum chemoprophylaxis for GBS infection is provided (Figure 4). This revised algorithm is not an exclusive approach to management; variation that incorporates individual circumstances or institutional preferences may be appropriate.
Category D
Moderate evidence against efficacy or for adverse outcome
Level I
Evidence from at least one well designed randomized controlled trial
- GBS colonization. Such treatment is not effective in eliminating carriage or preventing neonatal disease and may cause adverse consequences.
Not graded
- Health-care providers should inform women of their
GBS screening test result and the recommended interventions. In the absence of
GBS urinary tract infection, antimicrobial agents should not be used before the
intrapartum period to treat .
- Local and state public health agencies, in conjunction with appropriate groups of hospitals, are encouraged to establish surveillance for early-onset GBS disease and to take other steps to promote perinatal GBS disease prevention and education to reduce the incidence of early-onset GBS disease in their states. Efforts to monitor the emergence of perinatal infections caused by other organisms are also encouraged.
