Syphilis Immunoassay Signal Strength Correlates with Active Infection in Pregnant Women.

OBJECTIVE: This study aimed to evaluate the association of ARCHITECT chemiluminescent immunoassay (CIA) signal strength (signal-to-cutoff [S/CO] ratio), with maternal syphilis stage, rapid plasma reagin (RPR) reactivity, and congenital syphilis. STUDY DESIGN: A prospective observational study of reverse syphilis screening was conducted. Pregnant women were screened with CIA. Reactive CIA was reflexed to RPR; particle agglutination test (Treponema pallidum particle agglutination [TPPA]) was performed for CIA+/RPR- results. Clinical staging with history and physical was performed, and disease stage was determined. Prior treatment was confirmed. We compared S/CO ratio and neonatal outcomes among the following groups: Group 1: CIA+/RPR+/TPPA+ or CIA+/RPR-/TPPA+ with active syphilis; Group 2: CIA+/RPR-/TPPA+ or CIA+/serofast RPR/TPPA+, previously treated; Group 3: CIA+/RPR-/TPPA+, no history of treatment or active disease; Group 4: CIA+/RPR-/TPPA-, false-positive CIA. RESULTS: A total of 144 women delivered with reactive CIA: 38 (26%) in Group 1, 69 (48%) in Group 2, 20 (14%) in Group 3, and 17 (12%) in Group 4. Mean (±standard deviation) S/CO ratio was 18.3 ± 5.4, 12.1 ± 5.3, 9.1 ± 4.6, and 1.9 ± 0.8, respectively (p < 0.001). Neonates with overt congenital syphilis occurred exclusively in Group 1. CONCLUSION: Women with active syphilis based on treatment history, clinical staging, and laboratory indices have higher CIA S/CO ratio and are more likely to deliver neonates with overt evidence of congenital syphilis.

Factors Associated with Postpartum Loss to Follow-Up and Detectable Viremia After Delivery Among Pregnant Women Living with HIV.

Pregnant women living with HIV are at risk for loss to follow-up and viral rebound after delivery. We conducted a retrospective cohort study of women with HIV who delivered at Parkland Hospital, Dallas, to identify factors associated with postpartum loss to HIV care 1 year after delivery. Logistic regression was used to identify factors predicting loss to follow-up. For a subset of women, we compared odds of viremia detectable at delivery and postpartum among women with higher versus lower pill burden regimens. We included 604 women with HIV who delivered between 2005 and 2015. Three hundred ninety-one (65%) women completed at least one visit with an HIV provider within 1 year of delivery. The follow-up rate among black, non-Hispanic women was 65%; 57% for white, non-Hispanic women; and 78% for Hispanic women. Women without follow-up presented for prenatal care later (17 vs. 11 weeks, p < 0.001), and were less likely to be on antiretroviral therapy at initial prenatal visit (29% vs. 49%, p < 0.001). Factors predicting loss to follow-up in multivariate analysis included low-level viremia at delivery [adjusted odds ratio (aOR) = 2.85, 95% confidence interval (CI) = 1.73-4.71] and failure to return for a postpartum visit (aOR = 3.19, 95% CI = 2.07-4.94). High antiretroviral pill burden (≥6 pills daily) was associated with viremia (>1000 copies/mL) at the first prenatal visit (OR = 8.7, 95% CI = 4.6-16.6) through 1 year postpartum (OR = 2.3, 95% CI = 1.2-4.4). Viremia at delivery, failure to return for a postpartum visit, and high pill burden during pregnancy are predictors of postpartum loss to HIV care.

Diagnostic accuracy of fourth-generation ARCHITECT HIV Ag/Ab Combo assay and utility of signal-to-cutoff ratio to predict false-positive HIV tests in pregnancy.

BACKGROUND: False-positive HIV screening tests in pregnancy may lead to unnecessary interventions in labor. In 2014, the Centers for Disease Control and Prevention released a new algorithm for HIV diagnosis using a fourth-generation screening test, which detects antibodies to HIV as well as p24 antigen and has a shorter window period compared with prior generations. A reactive screen requires a differentiation assay, and supplemental qualitative RNA testing is necessary for nonreactive differentiation assay. One screening test, the ARCHITECT Ag/Ab Combo assay, is described to have 100% sensitivity and >99% specificity in nonpregnant populations; however, its clinical performance in pregnancy has not been well described. OBJECTIVE: The objective of the study was to determine the performance of the ARCHITECT assay among pregnant women at a large county hospital and to assess whether the relative signal-to-cutoff ratio can be used to differentiate between false-positive vs confirmed HIV infections in women with a nonreactive differentiation assay. STUDY DESIGN: This is a retrospective review of fourth-generation HIV testing in pregnant women at Parkland Hospital between June 1, 2015, and Jan. 31, 2017. We identified gravidas screened using the ARCHITECT Ag/Ab Combo assay (index test), with reflex to differentiation assay. Women with reactive ARCHITECT and nonreactive differentiation assay were evaluated with a qualitative RNA assay (reference standard). We calculated sensitivity, specificity, predictive value, and false-positive rate of the ARCHITECT screening assay in our population and described characteristics of women with false-positive HIV testing vs confirmed infection. Among women with a nonreactive differentiation assay, we compared interventions among women with and without a qualitative RNA assay result available at delivery and examined relative signal-to-cutoff ratios of the ARCHITECT assay in women with false-positive vs confirmed HIV infection. RESULTS: A total of 21,163 pregnant women were screened using the ARCHITECT assay, and 190 tested positive. Of these, 33 of 190 (17%) women had false-positive HIV screening tests (28 deliveries available for analysis), and 157 of 190 (83%) had confirmed HIV-1 infection (140 available for analysis). Diagnostic accuracy of the ARCHITECT HIV Ag/Ab Combo assay in our prenatal population (with 95% confidence interval) was as follows: sensitivity, 100% (97.7-100%); specificity, 99.8% (99.8-99.9%); positive likelihood ratio, 636 (453-895); negative likelihood ratio, 0.0 (NA); positive predictive value, 83% (77-88%); and false positive rate, 0.16% (0.11-0.22%), with a prevalence of 7 per 1000. Women with false-positive HIV testing were younger and more likely of Hispanic ethnicity. A qualitative RNA assay (reference standard) was performed prenatally in 24 (86%) and quantitative viral load in 22 (92%). Interventions occurred more frequently in women without a qualitative RNA assay result available at delivery, including intrapartum zidovudine (75% vs 4%, P = .002), breastfeeding delay (75% vs 8%, P = .001), and neonatal zidovudine initiation (75% vs 4%, P = .002). The ARCHITECT signal-to-cutoff ratio was significantly lower for women with false-positive HIV tests compared with those with established HIV infection (1.89 [1.27, 2.73] vs 533.65 [391.12, 737.22], respectively, P < .001). CONCLUSION: While the performance of the fourth-generation ARCHITECT HIV Ag/Ab Combo assay among pregnant women is comparable with that reported in nonpregnant populations, clinical implications of using a screening test with a positive predictive value of 83% in pregnancy are significant. When the qualitative RNA assay result is unavailable, absence of risk factors in combination with an ARCHITECT HIV Ag/Ab assay S/Co ratio <5 and nonreactive differentiation assay provide sufficient evidence to support deferral of unnecessary intrapartum interventions while awaiting qualitative RNA results.

Infant outcomes among women with Zika virus infection during pregnancy: results of a large prenatal Zika screening program.

BACKGROUND: Zika virus infection during pregnancy is a known cause of congenital microcephaly and other neurologic morbidities. OBJECTIVE: We present the results of a large-scale prenatal screening program in place at a single-center health care system since March 14, 2016. Our aims were to report the baseline prevalence of travel-associated Zika infection in our pregnant population, determine travel characteristics of women with evidence of Zika infection, and evaluate maternal and neonatal outcomes compared to women without evidence of Zika infection. STUDY DESIGN: This is a prospective, observational study of prenatal Zika virus screening in our health care system. We screened all pregnant women for recent travel to a Zika-affected area, and the serum was tested for those considered at risk for infection. We compared maternal demographic and travel characteristics and perinatal outcomes among women with positive and negative Zika virus tests during pregnancy. Comprehensive neurologic evaluation was performed on all infants delivered of women with evidence of possible Zika virus infection during pregnancy. Head circumference percentiles by gestational age were compared for infants delivered of women with positive and negative Zika virus test results. RESULTS: From March 14 through Oct. 1, 2016, a total of 14,161 pregnant women were screened for travel to a Zika-affected country. A total of 610 (4.3%) women reported travel, and test results were available in 547. Of these, evidence of possible Zika virus infection was found in 29 (5.3%). In our population, the prevalence of asymptomatic or symptomatic Zika virus infection among pregnant women was 2/1000. Women with evidence of Zika virus infection were more likely to have traveled from Central or South America (97% vs 12%, P < .001). There were 391 deliveries available for analysis. There was no significant difference in obstetric or neonatal morbidities among women with or without evidence of possible Zika virus infection. Additionally, there was no difference in mean head circumference of infants born to women with positive vs negative Zika virus testing. No microcephalic infants born to women with Zika infection were identified, although 1 infant with hydranencephaly was born to a woman with unconfirmed possible Zika disease. Long-term outcomes for infants exposed to maternal Zika infection during pregnancy are yet unknown. CONCLUSION: Based on a large-scale prenatal Zika screening program in an area with a predominantly Hispanic population, we identified that 4% were at risk from reported travel with only 2/1000 infected. Women traveling from heavily affected areas were most at risk for infection. Neonatal head circumference percentiles among infants born to women with evidence of possible Zika virus infection during pregnancy were not reduced when compared to infants born to women without infection.

Benefit of interpregnancy HIV viral load suppression on subsequent maternal and infant outcomes.

OBJECTIVE: The objective of the study was to determine whether interpregnancy human immunodeficiency virus (HIV) viral load suppression affects outcomes in subsequent pregnancies. STUDY DESIGN: This is a retrospective review of all women who delivered 2 consecutive pregnancies while diagnosed with HIV from Jan. 1, 1984, until Jan. 1, 2012. Medical records were reviewed for maternal, infant, and delivery data. Pregnancies were divided into index and subsequent pregnancy and analyzed for outcomes. RESULTS: During the study period, 172 HIV-infected women who delivered 2 pregnancies at our institution were identified. There was no difference in median HIV viral load at presentation or delivery between the index and subsequent pregnancies. During the subsequent pregnancy, more women presented on antiretroviral therapy (ART) and more often remained compliant with ART; however, there was no difference in vertical transmission risk between the pregnancies. Of those with a viral load less than 1000 copies/mL at the end of their index pregnancy (n = 103), 57 (55%) presented for their subsequent pregnancy with a viral load still less than 1000 copies/mL. Those women who maintained the viral load suppression between pregnancies were more likely to present for their subsequent pregnancy on ART, maintained a greater viral load suppression and CD4 counts during the pregnancy, and had fewer vertical transmissions compared with those who presented with higher viral loads in their subsequent pregnancy (0% vs 9%, P = .02). CONCLUSION: Maintaining an HIV viral load suppression between pregnancies is associated with improved HIV disease status at delivery in subsequent pregnancies. Interpregnancy HIV viral load suppression is associated with less vertical transmission, emphasizing the importance of maintaining HIV disease control between pregnancies.

Prevention of mother-to-infant transmission of influenza during the postpartum period.

OBJECTIVES: The optimal management of infants born to mothers with peripartum influenza infection is not known. The objective of this study is to describe our experience with a practice guideline that promotes rooming-in and breast-feeding and to determine whether infants managed in this way acquire influenza infection. STUDY DESIGN: All mothers diagnosed with influenza infection within 8 days of delivery and their infants were included. Demographics, clinical characteristics, and outcome data were collected. Mothers were contacted at ~1 month after giving birth to determine if their infants had developed any signs suggestive of influenza infection. RESULTS: Forty-two women were diagnosed with peripartum influenza over the 2003 to 2005 and 2009 to 2010 seasons. Median onset of symptoms was 3 days before delivery, and median day of diagnosis was 1 day before delivery. The 42 infants had a median gestational age of 39 weeks; none were born earlier than 35 weeks. Ninety-five percent of the infants roomed-in with their mothers. Follow-up information was available on 95% of infants by 1 month; no infants had illness suggestive of influenza through the follow-up period. CONCLUSION: A guideline for the management of infants born to mothers with peripartum influenza infection, based on attention to hand hygiene, antiviral treatment for mothers, and encouragement of rooming-in and breast-feeding, was not associated with mother-to-infant influenza transmission over three separate influenza seasons.

Effect of influenza vaccination in the first trimester of pregnancy.

OBJECTIVE: To estimate the effect of first-trimester influenza vaccination on fetal and neonatal outcomes. METHODS: This was a retrospective cohort study examining delivery and neonatal outcomes after antepartum exposure to the seasonal trivalent inactive influenza vaccine. Data were collected and entered into an established computerized database. Outcomes by trimester of vaccination were then compared with women who did not receive the vaccine. RESULTS: During the 5-year study period, 10,225 women received the seasonal influenza vaccine antepartum; 8,690 of these delivered at our institution, 439 in the first trimester and 8,251 in the second and third trimesters. Women vaccinated antepartum were significantly older with higher parity than women who declined vaccination. Neonates born to mothers receiving the vaccine in any trimester did not have an increase in major malformations regardless of trimester of vaccination (2% regardless of vaccination group, P=.9). Stillbirth (0.3% compared with 0.6%, P=.006), neonatal death (0.2% compared with 0.4%, P=.01), and premature delivery (5% compared with 6%, P=.004) were significantly decreased in the vaccinated group. CONCLUSION: Influenza vaccination in the first trimester was not associated with an increase in major malformation rates and was associated with a decrease in the overall stillbirth rate. This information will aid in counseling women regarding the safety of influenza vaccination in the first trimester.

Maternal and neonatal outcomes after antepartum treatment of influenza with antiviral medications.

OBJECTIVE: To review the maternal and neonatal outcomes after antepartum exposure to M2 ion channel inhibitors or oseltamivir to provide some guidance on the risk, if any, of antiviral medication during pregnancy. METHODS: This was a retrospective cohort study examining maternal and neonatal outcomes after antepartum exposure to antiviral therapy for influenza. We evaluated maternal characteristics, pregnancy outcomes, and fetal outcomes and compared them with our overall obstetric population. RESULTS: Exposure to antiviral therapies (M2 ion channel inhibitors [n=104] compared with oseltamivir [n=135] compared with the control group [n=82,097]) during pregnancy was not associated with increased rates of preterm birth (7% compared with 10% compared with 6%, P=.190), premature rupture of membranes (23% compared with 16% compared with 22%, P=.154), gestational diabetes (4% compared with 8% compared with 6%, P=.388), or preeclampsia (6% compared with 1% compared with 4%, P=.209). Exposure was not associated with increased duration of hospital stay for mother or neonate. There were no differences in the incidence of minor malformations (19% compared with 15% compared with 22%, P=.101). Liveborn singletons without major malformations did not have differences in fetal weight (3,238+/-586 g compared with 3,281+/-642 g compared with 3,336+/-571 g, P=.186), need for intubation (2% compared with 0.8% compared with 1%, P=.552), intensive care nursery admission (3% compared with 3% compared with 2%, P=.418), or hyperbilirubinemia (12% compared with 9% compared with 8%, P=.282). Liveborn singletons had no grade 3 or 4 intraventricular hemorrhages, seizures, or neonatal deaths. Two preterm neonates exposed to different classes of medications had necrotizing enterocolitis (1.0% compared with 0.8% compared with 0.02%, P<.001). CONCLUSION: We found no evidence of an association between antepartum antiviral exposure and adverse outcomes. LEVEL OF EVIDENCE: II.

Ampicillin resistance and outcome differences in acute antepartum pyelonephritis.

OBJECTIVE: To measure the incidence of ampicillin-resistant uropathogens in acute antepartum pyelonephritis and to determine if patients with resistant organisms had different clinical outcomes. STUDY DESIGN: This was a secondary analysis of a prospective cohort study of pregnant women admitted with pyelonephritis, diagnosed by standard clinical and laboratory criteria. All patients received ampicillin and gentamicin. RESULTS: We identified 440 cases of acute pyelonephritis. Seventy-two percent (316 cases) had urine cultures with identification of organism and antibiotic sensitivities. Fifty-one percent of uropathogens were ampicillin resistant. The patients with ampicillin-resistant organisms were more likely to be older and multiparous. There were no significant differences in hospital course (length of stay, days of antibiotics, ECU admission, or readmission). Patients with ampicillin-resistant organisms did not have higher complication rates (anemia, renal dysfunction, respiratory insufficiency, or preterm birth). CONCLUSION: A majority of uropathogens were ampicillin resistant, but no differences in outcomes were observed in these patients.