The level of evidence (I-III) and classification of recommendations (A-E, I) are defined at the end of the "Major Recommendations."
Vertical Transmission and Risk of Congenital Rubella Syndrome
- Since the effects of congenital rubella syndrome vary with the gestational age at the time of infection, accurate gestational dating should be established, as it is critical to counselling. (II-3A)
Diagnosis of Rubella Infection
Diagnosis of Maternal Infection
- The diagnosis of primary maternal infection should be made by serological testing. (II-2A)
Management of Rubella Exposure/Infection in Pregnant Women
- In a pregnant woman who is exposed to rubella or who develops signs or symptoms of rubella, serological testing should be performed to determine immune status and risk of congenital rubella syndrome (III-A)
The Vaccine
- Rubella immunization should not be administered in pregnancy but may be safely given post partum. (III-B)
- Women who have been inadvertently vaccinated in early pregnancy or who become pregnant immediately following vaccination can be reassured that there have been no cases of congenital rubella syndrome documented in these situations. (III-B)
Prevention
- Women wishing to conceive should be counseled and encouraged to have their antibody status determined and undergo rubella vaccination if needed. (I-A)
Definitions:
Quality of Evidence Assessment*
I: Evidence obtained from at least one properly designed randomized controlled trial.
II-1: Evidence obtained from well-designed controlled trials without randomization.
II-2: Evidence obtained from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one center or research group.
II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results from uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category.
III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
Classification of Recommendations**
A. There is good evidence to recommend the clinical preventive action.
B. There is fair evidence to recommend the clinical preventive action.
C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making
D. There is fair evidence to recommend against the clinical preventive action.
E. There is good evidence to recommend against the clinical preventive action.
I. There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making
*The quality of evidence reported in these guidelines has been adapted from The Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care.
**Recommendations included in these guidelines have been adapted from the Classification of Recommendations criteria described in the Canadian Task Force on Preventive Health Care.
