Rockville (MD): Agency for Healthcare Research and Quality (US); 2019 Jul. Report No.: 19-05248-EF-1.
U.S. Preventive Services Task Force Evidence Syntheses, formerly Systematic Evidence Reviews.
To update the 2009 U.S. Preventive Services Task Force (USPSTF) “A” recommendation on screening for hepatitis Bvirus (HBV) infection in pregnancy, we systematically reviewed evidence on the benefits (Key Question [KQ] 1) and harms (KQ 2) of universal screening programs for HBV infection in pregnant women, and the benefits (KQ 3) and harms (KQ 4) of case management programs to prevent perinatal transmission.
We conducted a literature search of MEDLINE, PubMed Publisher-Supplied Records, the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, the Cumulative Index for Nursing and Allied Health Literature, Embase, and PsycInfo from January 1, 1986 to May 3, 2018.
We screened 5,688 titles and abstracts and 499 full-text articles to identify eligible studies based on a priori inclusion and exclusion criteria.
Two investigators independently appraised any article that met inclusion criteria using design-specific criteria. We abstracted and narratively synthesized included study data.
No studies were identified for KQs 1 or 2 that addressed either the effects of screening programs on perinatal HBV transmission or the potential harms of screening. Two fair-quality observational studies that compared perinatal transmission rates over time were included for KQ 3. One study reported outcomes of case management for infants with data reported to the national Perinatal Hepatitis B Prevention Program (PHBPP), administered by the Centers for Disease Control and Prevention (CDC). In the PHBPP, 155,081 infants born to HBV-positive women were identified for case management from 1994 to 2008; perinatal transmission outcomes were available for infants born from 1999 to 2008 who received serologic testing (N=55,362). A statistically significant decline in the perinatal transmission rate was observed; perinatal transmission was reported for 1.9 percent of case-managed infants in 1999 and 0.8 percent in 2008 (p<0.001). Over the study period, the number of infants born to HBV-positive women increased in the United States, and an increasing proportion of infants born to HBV-positive women were enrolled in the PHBPP for case management (p<0.001). Serologic testing within 24 months of birth also increased across the time period (p=0.001). The second study reported outcomes of case management for infants born to HBV-positive women in a large regional health care organization in the United States. The health system case management program reported on 4,446 infants born to HBV-positive women from 1997 to 2010. Over this period, 85 percent of infants were tested for HBV, and a decreasing trend in perinatal transmission was reported (incident rate ratio, 0.90 [95% confidence interval, 0.82 to 1.00]). Overall rates of perinatal transmission were very low (25 of 3,353 of infants tested [0.75%]). More than 97 percent of case-managed infants received HBV vaccination and hepatitis B immune globulin within 12 hours of birth. No studies were identified for KQ 4 to assess potential harms of case management.
Our review was narrowly focused on evidence of the effectiveness of screening or case management on prevention of perinatal transmission in contexts where prenatal screening and universal vaccination for HBV at birth are established practice. The included observational studies’ findings on declining perinatal transmission trends could be influenced by secular changes in other public health activities (e.g., universal HBV vaccination) or by improvements within case management program implementation and interventions (e.g., antiviral medication). Changes in data collection and reporting methods used in the studies could also introduce bias.
Perinatal transmission would be observed in more than one third of infants born to HBV-positive mothers in the absence of prophylaxis. Very low and declining rates of perinatal transmission have been documented for infants in case management programs that track and coordinate the delivery of preventive interventions. Screening for HBV infection in pregnancy is standard prenatal care practice in the United States and identifies women and infants eligible for effective case management for effective interventions to prevent perinatal transmission.