Guideline No. 409: Intrauterine Fetal Diagnostic Testing in Women with Chronic Viral Infections

ABSTRACT Objective This revised guideline provides updated information for the care of women with chronic viral infections who require intrauterine fetal diagnostic testing. Target Population Women with chronic viral infections who are pregnant or planning a pregnancy. Options Non-invasive screening tests for diagnosis: maternal serum placental analytes with or without nuchal translucency, sonography, maternal serum cell-free placental DNA; and intrauterine fetal diagnostic testing: amniocentesis, chorionic villus sampling, cordocentesis. Outcomes The recommendations in this guideline have the potential to decrease or eliminate morbidity and mortality in women with chronic viral infections and their infants, which is associated with significant health and economic outcomes. Evidence Published literature was retrieved through searches of PubMed, guidelines of national societies (Society of Obstetricians and Gynaecologists of Canada, American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine, other international societies), and the Cochrane Library using appropriate controlled vocabulary (amniocentesis, chorionic villus sampling, cordocentesis, procedure pregnancy loss risk, viral vertical transmission, fetal and neonatal infection) and keywords (maternal infection or exposure, hepatitis B, hepatitis C, human immunodeficiency virus). Results were restricted to systematic reviews, randomized controlled trials or controlled clinical trials (if available), and observational case-control studies or case series from 2012 to 2019 published in English or French. Studies from 1966 to 2002 were previously reviewed in the SOGC guideline No. 123: Amniocentesis and Women with Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus, and those from 2002 to 2012 were previously reviewed in the SOGC guideline No. 309: Prenatal Invasive Procedures in Women With Hepatitis B, Hepatitis C, and/or Human Immunodeficiency Virus Infections. Updated literature searches were completed regularly through August 2019 and were incorporated into this guideline. Validation Methods The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and weak recommendations). Intended Audience The intended users are maternity care providers and women with chronic viral infections. This guideline provides information to educate and counsel these women, and to offer them reproductive options. RECOMMENDATIONS (GRADE ratings in parentheses) 1For women with a chronic infection with hepatitis B, hepatitis C, and/or human immunodeficiency virus (HIV), the use of non-invasive methods of fetal aneuploidy risk assessment is recommended, using screening tests with high sensitivity and low false-positive rates (maternal serum placental analytes with or without nuchal translucency, detailed sonography [dating crown-rump length, first- and second-trimester anatomic] and maternal serum cell-free placental DNA as first- or second-tier screening test) (strong, moderate). 2When counselling pregnant women with a chronic infection that can pose a risk of perinatal morbidity regarding intrauterine fetal diagnostic genetic and/or infectious testing: •The pregnancy loss rate (spontaneous loss rate and rate due to the procedure) discussed should be based on the gestational age at the time of the procedure (strong, high). •The first trimester (when chorionic villus sampling is performed) has an estimated spontaneous pregnancy loss rate of 1.40% (based on a population cohort of maternal age >36 years with normal first-trimester sonographic screening); the second trimester (when amniocentesis is performed) has an estimated spontaneous pregnancy loss rate of 0.65% (based on a population cohort of maternal age >36 years with normal second-trimester sonographic screening) (strong, high). •The estimated risk of pregnancy loss due to amniocentesis is 0.35% to 1.00%, based on systematic reviews or meta-analyses, cohort studies with control groups, and randomized controlled trials; the risk varies depending on provider expertise (strong, high). 3When performing sonography-guided amniocentesis for women with a chronic hepatitis B, hepatitis C, and/or HIV infection, every effort should be made to avoid the amniocentesis needle going through the placenta or within 1 to 2 cm of the implantation placental edge (strong, moderate). Hepatitis B 4Hepatitis B virus DNA load should be evaluated in women with positive hepatitis B surface antigen status who require intrauterine fetal diagnostic testing. A viral DNA load >200 000 IU/mL or >106 copies/mL and positive hepatitis B e antigen status increase the risk of vertical transmission (strong, moderate). 5In women with chronic hepatitis B infection and a significant viral load (>200 000 IU/mL or >106 copies/mL), maternal antiviral therapy should be considered in order to decrease the vertical transmission risk. The first-line antenatal antiretroviral agent tenofovir is recommended (strong, moderate). Hepatitis C 6In women with chronic hepatitis C infection, amniocentesis is recommended over chorionic villus sampling due to the limited data available on chorionic villus sampling (conditional, low). 7Amniocentesis in women with a chronic hepatitis C infection does not appear to significantly increase the risk of vertical transmission of the virus; however, there is limited published cohort data, and this information should be shared with the patient during the informed consent process (conditional, low). HIV 8Pregnant women with HIV have reported pregnancy loss rates after amniocentesis of 2.6% to 22% (although only small cohorts have been reported) and vertical transmission rates of 0% to 2.3%. Data evaluating the clinical use of amniocentesis among women with HIV is increasing but still limited, and this information should be shared with women during the informed consent process (conditional, low). 9Amniocentesis in women with HIV who are treated with combination antiretroviral therapy appears to pose no increased risk of vertical transmission of HIV, especially if the antiviral therapy reduces the maternal viral load to undetectable levels (strong, high).