Pregnancy Complications Associated With Bacterial Vaginosis and Their Estimated Costs

Objective: This study was undertaken to estimate the annual direct costs of complications associated with bacterial vaginosis (BV) in pregnant women in the United States

Haemophilus influenzae septic abortion.

BACKGROUND: Haemophilus influenzae septic abortion is typically caused by nontypeable strains of the organism. Furthermore, nontypeable species with a special affinity for the genital tract are the most frequent isolates encountered, and an ascending vaginal or cervical infection is often the suspected route of transmission. CASE: A 39-year-old woman at 8 weeks gestation who underwent dilation, evacuation, and curettage for embryonic demise had clinical evidence for sepsis and isolation of a nontypeable, ampicillin resistant H. influenzae from blood cultures. Although an ascending vaginal infection was suspected, the route of transmission was not determined. CONCLUSION: Nontypeable strains of. H. influenzae have demonstrated increased beta-lactamase activity, and ampicillin, formerly the treatment of choice, should be used only if isolate susceptibility is known

Women’s perspectives on Human Papillomavirus self-sampling in the context of the UK cervical screening programme

Background: Testing for human papillomavirus (HPV) is being incorporated into the cervical screening programme, with the probable future introduction of HPV as a primary test and a possibility of HPV self-sampling. In anticipation of this development, we sought to inform future policy and practice by identifying potential barriers to HPV self-sampling. Methods: A cross-sectional survey of 194 women aged 20-64 years was conducted. Logistic regression analysis was used to identify determinants of self-sampling intentions. A purposive subsample of 19 women who reported low self-sampling intentions were interviewed. Interviews were framework-analysed. Results: Most survey participants (N=133, 69.3%) intended to HPV self-sample. Lower intention was associated with lower self-efficacy (OR=24.96, P≤.001), lower education (OR=6.06, P≤.05) and lower perceived importance of HPV as a cause of cervical cancer (OR=2.33, P≤.05). Interviews revealed personal and system-related barriers. Personal barriers included a lack of knowledge about HPV self-sampling, women’s low confidence in their ability to self-sample correctly and low confidence in the subsequent results. System-related factors included a lack of confidence in the rationale for modifying the current cervical screening programme, and concerns about sample contamination and identity theft. Conclusions: Insights gained from this research can be used to guide further enquiry into the possibility of HPV self-sampling and to help inform future policy and practice. Personal and system-related barriers including low confidence in the reasons for changing current cervical screening provision need to be addressed, should HPV self-sampling be incorporated into the cervical screening programme

Randomized Trial of Antibiotics in Addition to Tocolytic Therapy to Treat Preterm Labor

Objective: The objective of this study was to assess whether antibiotic therapy plus tocolysis given to women in preterm labor would prolong pregnancy compared with tocolysis alone

Effects of Long-Term Use of Nonoxynol-9 on Vaginal Flora

OBJECTIVE—Products containing nonoxynol-9 have been used as spermicidal contraceptives for many years, but limited data have been published describing the long-term effects of nonoxynol-9 use on the vaginal microbial ecosystem. This longitudinal study was conducted to examine the effects of nonoxynol-9 on the vaginal ecology. METHODS—Vaginal swabs were obtained from 235 women enrolled in a randomized clinical trial before initiation of use of 1 of 5 different formulations of nonoxynol-9 for contraception, and up to 3 more samples were gathered over 7 months of use. The swab samples were evaluated in a single laboratory. The prevalence of several constituents of the normal vaginal flora was evaluated. The associations between nonoxynol-9 dosage, formulation, average product use per week, and number of sex acts per week were calculated. RESULTS—The changes in prevalence of vaginal microbes after nonoxynol-9 use were minimal for each of the different nonoxynol-9 formulations. However, when both nonoxynol-9 concentration and number of product uses are taken into account, nonoxynol-9 did have dose-dependant effects on the increased prevalence of anaerobic gram-negative rods (odds ratio [OR] 2.4, 95% confidence interval [CI] 1.1–5.3), H2O2-negative lactobacilli (OR 2.0, 95% CI 1.0–4.1), and bacterial vaginosis (OR 2.3, 95% CI 1.1–4.7). CONCLUSION—This study demonstrated that most nonoxynol-9 users experienced minimal disruptions in their vaginal ecology. There were no differences between the different formulations evaluated with respect to changes in vaginal microflora. However, independent of the nonoxynol-9 formulation, there was a dose-dependent effect with increased exposure to nonoxynol-9 on the risk of bacterial vaginosis and its associated flora

Analysis of Factors Driving Incident and Ascending Infection and the Role of Serum Antibody in Chlamydia trachomatis Genital Tract Infection

Background. Chlamydia trachomatis genital tract infection is a major cause of female reproductive morbidity. Risk factors for ascending infection are unknown, and the role for antibody in protection is not well established

Comparative Study of Intravaginal Metronidazole and Triple-Sulfa Therapy for Bacterial Vaginosis

Objective: We sought to compare the efficacy of metronidazole gel vs. triple-sulfa cream in the treatment of bacterial vaginosis (BV)

Gene Expression Signatures Can Aid Diagnosis of Sexually Transmitted Infection-Induced Endometritis in Women

Sexually transmitted infection (STI) of the upper reproductive tract can result in inflammation and infertility. A biomarker of STI-induced upper tract inflammation would be significant as many women are asymptomatic and delayed treatment increases risk of sequelae. Blood mRNA from 111 women from three cohorts was profiled using microarray. Unsupervised analysis revealed a transcriptional profile that distinguished 9 cases of STI-induced endometritis from 18 with cervical STI or uninfected controls. Using a hybrid feature selection algorithm we identified 21 genes that yielded maximal classification accuracy within our training dataset. Predictive accuracy was evaluated using an independent testing dataset of 5 cases and 10 controls. Sensitivity was evaluated in a separate test set of 12 women with asymptomatic STI-induced endometritis in whom cervical burden was determined by PCR; and specificity in an additional test set of 15 uninfected women with pelvic pain due to unknown cause. Disease module preservation was assessed in 42 women with a clinical diagnosis of pelvic inflammatory disease (PID). We also tested the ability of the biomarker to discriminate STI-induced endometritis from other diseases. The biomarker was 86.7% (13/15) accurate in correctly distinguishing cases from controls in the testing dataset. Sensitivity was 83.3% (5/6) in women with high cervical Chlamydia trachomatis burden and asymptomatic endometritis, but 0% (0/6) in women with low burden. Specificity in patients with non-STI-induced pelvic pain was 86.7% (13/15). Disease modules were preserved in all 8 biomarker predicted cases. The 21-gene biomarker was highly discriminatory for systemic infections, lupus, and appendicitis, but wrongly predicted tuberculosis as STI-induced endometritis in 52.4%. A 21-gene biomarker can identify asymptomatic women with STI-induced endometritis that places them at risk for chronic disease development and discriminate STI-induced endometritis from non-STI pelvic pain and other diseases

Identification of Chlamydia trachomatis Antigens Recognized by T Cells From Highly Exposed Women Who Limit or Resist Genital Tract Infection

Background. Natural infection induces partial immunity to Chlamydia trachomatis. Identification of chlamydial antigens that induce interferon γ (IFN-) secretion by T cells from immune women could advance vaccine development

Tenofovir vaginal film as a potential MPT product against HIV-1 and HSV-2 acquisition: formulation development and preclinical assessment in non-human primates

Tenofovir (TFV) is an adenosine nucleotide analog with activity against HIV and HSV-2. Secondary analyses of clinical trials evaluating TFV gel as pre-exposure prophylaxis (PrEP) for HIV have shown that gel formulations of TFV provide significant protection against both HIV and HSV-2 acquisition in women who had evidence of use. An alternate quick-dissolving polymeric thin film, to deliver TFV (20 and 40 mg) has been developed as a potential multipurpose technology (MPT) platform. Film formulation was developed based on excipient compatibility, stability, and ability to incorporate TFV doses. Placebo, low dose (20 mg), and high dose (40 mg) films were utilized in these studies. The developed film platform efficiently incorporated the high dose of TFV (40 mg/film), released more than 50% of drug in 15 min with no in vitro toxicity. Pharmacological activity was confirmed in an ex vivo HIV-1 challenge study, which showed a reduction in HIV-1 infection with TFV films. Films were stable at both doses for at least 2 years. These films were found to be safe in macaques with repeated exposure for 2 weeks as evidenced by minimal perturbation to tissues, microbiome, neutrophil influx, and pH. Macaque sized TFV film (11.2 mg) evaluated in a pigtail macaque model showed higher vaginal tissue concentrations of TFV and active TFV diphosphate compared to a 15 mg TFV loaded gel. These studies confirm that TFV films are stable, safe and efficiently deliver the drug in cervicovaginal compartments supporting their further clinical development