Declining Chlamydia and Gonorrhea Diagnoses Among Pregnant Women in South Carolina, 2008 to 2018.

BACKGROUND: Reported US cases of chlamydia and gonorrhea have increased since 2000, whereas studies in select populations suggest that the prevalence of these diseases has decreased. We sought to determine if these diagnoses are increasing among pregnant women delivering at our center. METHODS: This is a retrospective study of women delivering at least 1 infant >18 weeks of gestation at the Medical University of South Carolina for 11 years (2008-2018). Using the perinatal information system, we collected maternal race, age, insurer, and chlamydia and gonorrhea screening results during the pregnancy of record. Cochran-Armitage trend analyses were performed to evaluate trends in these diagnoses by delivery year for all women and for age/race subgroups. RESULTS: During the study period, there were 24,807 deliveries. The median age of women was 28 years (interquartile range, 23-32 years). Five percent (5.0%) of women were diagnosed with chlamydia and 1.2% with gonorrhea. The percent of women diagnosed decreased for both chlamydia (9.6%-3.4%) and gonorrhea (2.5%-1.1%; P < 0.001, trend analyses for both). A higher percentage of Black women had chlamydia and gonorrhea, and both diagnoses declined over time: 17.4% to 6.9% (P < 0.0001) for chlamydia and 5.8% to 2.1% (P < 0.0001) for gonorrhea. In a subanalysis of race and age, Black women younger than 25 years experienced the most significant decline in chlamydia diagnoses (P < 0.0001). CONCLUSIONS: We observed declining diagnoses of chlamydia and gonorrhea among pregnant women in our center. Although Black women delivering were more likely to have either diagnoses, they experienced a significant decline in both chlamydia and gonorrhea over time.

Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population.

OBJECTIVES: The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform. METHODS: In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA). RESULTS: The κ and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2. CONCLUSIONS: The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.

Clinical evaluation of the cartridge-based GeneXpert human papillomavirus assay in women referred for colposcopy.

High-risk human papillomavirus (hrHPV) testing is now being introduced as a potential primary screening test for improved detection of cervical precancer and cancer. Current U.S. Food and Drug Administration-approved tests are batch tests that take several hours to complete. A rapid, non-batch test might permit point-of-care (POC) testing, which can facilitate same-day screen and management strategies. For a non-batch, random-access platform (GeneXpert; Cepheid, Sunnyvale, CA), a prototype hrHPV assay (Xpert) has been developed where testing for 14 hrHPV types can be completed in 1 h. In the first clinical evaluation, Xpert was compared to two validated hrHPV tests, the cobas HPV test (cobas, Roche Molecular Systems) and Hybrid Capture 2 (hc2, Qiagen), and to histologic outcomes using specimens from colposcopy referral populations at 7 clinical sites in the United States (n = 697). The sensitivity of Xpert for cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2+) (n = 141) was equal to that of cobas (90.8% versus 90.8%, P = 1) and greater than that of hc2 (90.8% versus 81.6%, P = 0.004). Xpert was more specific than cobas (42.6% versus 39.6%, P = 0.02) and less specific than hc2 (42.6% versus 47.7%, P < 0.001). Similar results were observed for cervical intraepithelial neoplasia grade 3 or higher (CIN3+) (n = 91). HPV16 detection by Xpert identified 41.8% of the CIN2+ specimens with a positive predictive value (PPV) of 54.6%. By comparison, HPV16 detection by cobas identified 42.6% of the CIN2+ specimens with a PPV of 55.0%. hrHPV detection by the Xpert demonstrated excellent clinical performance for identifying women with CIN2+ and CIN3+ that was comparable to that of currently available clinically validated tests.

Cost-effectiveness analysis of 2 surveillance options for cervical intraepithelial neoplasia 1.

OBJECTIVE: We aim to determine the difference in cost between 2 accepted surveillance strategies for women diagnosed with cervical intraepithelial neoplasia 1 (CIN 1): repeat cytology at 6 and 12 months versus human papillomavirus (HPV) DNA testing at 12 months. MATERIALS AND METHODS: Extracting data from the literature regarding the natural history of HPV infection and CIN 1, we estimated regression, persistence, and progression rates during a 2-year interval. Costs were based on 2011 Medicaid reimbursements for cytology, biopsy interpretation, HPV testing, and the associated office visit or procedure fee. We constructed a decision tree model to estimate the potential cost benefits of using HPV testing, and sensitivity analyses were performed. Treatment costs for high-grade disease were not included because of equal occurrence in both groups. RESULTS: In a hypothetical cohort of 100 women with CIN 1 (assumed compliant with 2 y of follow-up), the total cost for cytology-based follow-up was $89,969, whereas the total cost for HPV-based follow-up was $37,357. This indicates an average cost savings of $526 per patient in favor of HPV testing. If we then consider the 234,603 incident cases of CIN 1 in the United Sates per year, preferential use of HPV-based follow-up would save $123,429,305. CONCLUSIONS: Although both cytology and HPV testing are sound methods for surveillance of CIN 1, it is more cost-effective to use HPV testing.

Predictors of long-acting reversible contraception use among unmarried young adults.

OBJECTIVE: The objective of the study was to improve the understanding of long-acting reversible contraception (LARC) use patterns among unmarried, young adults at risk of unintended pregnancy. STUDY DESIGN: We performed a secondary data analysis of a national survey conducted by Guttmacher Institute of unmarried women and men aged 18-29 years. LARC is defined as an intrauterine device (IUD) or implant. Predictors of LARC use and IUD knowledge among those at risk for unintended pregnancy (n = 1222) were assessed using χ(2) analysis and logistic regression models. RESULTS: LARC use was associated with older age, high IUD knowledge, and earlier onset of sexual activity. Respondents with high IUD knowledge were 6 times more likely to be current LARC users (odds ratio [OR], 6.3; 95% confidence interval [CI], 1.4-28.8). Sociodemographic variables did not predict use. Respondents with lower education (OR, 1.76; 95% CI, 1.0-3.0), an external locus of control (OR, 1.6; 95% CI, 1.1-2.3), male sex (OR, 2.8; 95% CI, 1.9-4.1), and foreign language had less knowledge of IUD. CONCLUSION: Increasing knowledge of IUD among certain groups may improve LARC use among young, unmarried adults and in turn decrease unintended pregnancy.

The safety of prolonged indomethacin therapy.

The purpose of this study was to describe the fetal and newborn safety profile of prolonged indomethacin treatment during pregnancy. A retrospective cohort of 124 pregnant women treated with indomethacin was used to assess the outcomes of oligohydramnios, constriction of the ductus arteriosus, and composite neonatal morbidity. Eight patients (6.5%) developed ductal constriction and nine patients (7.3%) developed oligohydramnios. Composite morbidity occurred in 36 neonates (29%). Ductal constriction, oligohydramnios, and composite morbidity were not associated with duration of therapy, gestational age at start or stop of therapy, time between dosing and delivery, or dose regimen. Prolonged indomethacin therapy rarely is associated with ductal constriction and oligohydramnios.