Incidence and pattern of infections in pregnant women with bad obstetric history

Background: Adverse outcomes have been seen in pregnant women who had prior bad obstetric history along with infection with TORCH [toxoplasma, other infections (syphilis, varicella zoster, hepatitis B), rubella, cytomegalovirus, herpes simplex]complex and bacterial vaginosis. These infections are known to affect the health of the fetus. Objective was to study incidence and pattern of infections in pregnant women with bad obstetric history.Methods: A total of 190 patients with bad obstetric history fulfilling the methodology criteria were evaluated. Serological and molecular evaluations were carried out for TORCH complex and bacterial vaginosis was detected by both gram stain and gold standard clinical Amsel criteria and outcomes were followed.Results: Out of 190 pregnant women with bad obstetric history, a total of 36 (18.8%) were detected to have infections causing bad obstetric history. Toxoplasma was positive in 7 (20%) of the cases, 3 (51.92%) of them had abortions. Rubella in 12 (32%) of the cases, 7 (60%) cases had sensorineural deafness. Cytomegalovirus in 1 (2%) of the cases, 1 (100%) of the case had microcephaly. Herpes in 8 (22%) cases, 6 (71.1%) cases had abortions. Bacterial vaginosis in 8 (22%) of the cases, 4 (48.6%) cases had preterm delivery. The presence of infections with TORCH complex and bacterial vaginosis was related to adverse pregnancy outcomes.Conclusions: Women with bad obstetric history are prone to infections during pregnancy and have been found out to be associated with adverse pregnancy outcomes. Hence pregnant women should be screened so that early diagnosis and treatment of infections can be done to have better pregnancy outcomes.

Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

Background Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. Methods StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. Discussion Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. Trial registration The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

A phase 3, randomized, controlled trial of Astodrimer 1% Gel for preventing recurrent bacterial vaginosis

ObjectiveThe objective of the study was to confirm the efficacy and safety of Astodrimer 1% Gel to prevent recurrence of bacterial vaginosis.Study Design864 women with a diagnosis of bacterial vaginosis and a history of recurrent bacterial vaginosis were enrolled in North America and first received oral metronidazole (500 mg twice daily for 7 days). Women successfully treated with metronidazole were randomly assigned 1:1 to Astodrimer 1% Gel (N=295) or placebo (N=291) at a dose of 5 g vaginally every second day for 16 weeks, and followed for a further 12 weeks off-treatment. The primary endpoint was recurrence of bacterial vaginosis (presence of ≥3 Amsel criteria) at or by Week 16. Secondary endpoints included time to recurrence, and recurrence of subject-reported symptoms. Adverse events were monitored throughout the study.ResultsAstodrimer 1% Gel was superior to placebo for the primary and many secondary efficacy measures. At or by Week 16, bacterial vaginosis recurred in 44.2% (130/294) of women receiving astodrimer and 54.3% (158/291) receiving placebo (P=.015). Time to recurrence of bacterial vaginosis was significantly longer for women receiving astodrimer compared with placebo (Kaplan-Meier survival curves, P=.007). Recurrence of subject-reported symptoms at or by Week 16 was also significantly lower in the astodrimer arm compared with placebo (vaginal odor and/or discharge, 27.9% [75/269] vs 40.6% [108/266], P=.002). A significantly lower proportion of patients receiving astodrimer compared with placebo had recurrence of bacterial vaginosis at or by Week 16 by other secondary measures, including individual Amsel criteria (vaginal discharge and clue cells) and Nugent score 7-10. Recurrence of subject-reported vaginal odor and/or discharge was significantly lower in the astodrimer arm compared with placebo up to 8 weeks after cessation of therapy (36.1% [97/269] vs 45.5% [121/266], P=.027).Adverse events were infrequent, and rates were generally similar between placebo and astodrimer groups. Vulvovaginal candidiasis and urinary tract infection occurred more often in women receiving astodrimer.ConclusionsAstodrimer 1% Gel, administered every second day for 16 weeks, was effective and superior to placebo for prevention of recurrent bacterial vaginosis in women with a history of recurrent BV, and was well-tolerated.

Novel Non-Antibiotic Treatment of Bacterial Infections of the Vagina, A Proof of Concept Study using Single Dose and Triple Dose Regimen

The effect of a novel treatment principle for bacterial vaginosis has been investigated in an open clinical study. 10 patients received a single dose while 20 patients received three applications every third day. The formulation is in the form of vaginal foam, containing lactic acid, hydrogen peroxide and an antimicrobial lipid. The intention of using the foam form for delivery is to avoid the creation of untreated areas, as is the case for other local formulations. Clinical signs, symptom and microbial effects have been studied using strict Amsel criteria and modified Hay/Ison for inclusion and modified Hay/Ison to monitor clinical efficacy pre- and post- menstruation. Therapeutic parameters as pH, malodor, abnormal discharge, itch and pain were monitored during the study. The microbiological was monitored by PCR being able to detect 6 pathogens and Lactobacilli.

Efficacy of dequalinium chloride vaginal tablets in treatment of bacterial vaginosis

Aim: to evaluate the efficacy and duration of the therapeutic effect of dequalinium chloride (in comparison with clindamycin) in treatment of vaginal dysbiosis. Materials and methods. A total of 73 fertile-aged women (18-35 years old) with abnormal vaginal microbiota were examined. The patients were randomized into two groups: Group 1 (main) included 37 women receiving dequalinium chloride; Group 2 (control) included 36 women under clindamycin therapy. The efficacy was assessed by analyzing patients’ complaints, by gynecological examinations, pH values of the vaginal fluid, the Amsel criteria, the microscopy results and the polymerase chain reaction (PCR). Results. Before the treatment, the Amsel criteria were positive in 36 patients (97.29%) in the main group and in 31 patients (93.93%) in the control group; all patients showed an increase in the pH values of the vaginal fluid by more than 4.5 units. The state of vaginal microbiocenosis as evaluated with RT-PCR diagnostics (Femoflor 16 analysis) identified a variety of gram-positive and gram-negative bacteria with a marked decrease in the number of Lactobacilli. During the treatment period, there were no complaints of adverse events; pH values were normal in all patients; the Femoflor 16 analysis showed a significant decrease in the amounts of pathogenic microorganisms. As assessed in 1 month after the treatment, the therapeutic effect persisted. Conclusion. The dequalinium chloride has antibacterial effect on bacterial vaginosis. The results of the study showed that dequalinium chloride had the efficacy comparable with that of clindamycin.

Effect of a yoghurt drink containing Lactobacillus strains on bacterial vaginosis in women – a double-blind, randomised, controlled clinical pilot trial

Bacterial vaginosis (BV) is characterised by a depletion of lactobacilli in favour of an overgrowth of anaerobic bacteria. It is associated with increased risk for urogenital infections and abortion. In this study we assessed the effect of a yoghurt drink containing Lactobacillus strains on BV. The strains had been isolated from healthy pregnant women and selected for acidification capacity, production of H2O2, glycogen utilisation, bile salt tolerance and inhibition of pathogens. Using Amsel criteria BV was diagnosed in 36 women aged ≥18 years with stable menstrual cycle or menopause. They were treated with oral metronidazole for 7 days (2×500 mg/d). Starting with the treatment, women consumed twice daily either verum or placebo during 4 weeks. Verum was 125 g yoghurt containing (besides Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus thermophilus) living strains Lactobacillus crispatus LbV 88 (DSM 22566), Lactobacillus gasseri LbV 150N (DSM 22583), Lactobacillus jensenii LbV 116 (DSM 22567) and Lactobacillus rhamnosus LbV96 (DSM 22560), each 1×107 cfu/ml; placebo was 125 g chemically acidified milk. After 4 weeks of intervention 0 of 17 had BV in the verum group versus 6 of 17 in the s.a. control (0.018 in Fisher Exact test). Amsel score decreased during the intervention period by 4.0 (median) (4.0; 3.0) (25th; 75th percentile) in the verum group compared to 2.0 (4.0; 0.0) in the control group (P=0.038 in Mann-Whitney test). Discharge and odour (Amsel criteria 2+3) also decreased by 2.0 (2.0; 1.0) in the verum compared to 1.0 (2.0; 0.0) in the control group (P=0.01) and differed after 4 weeks intervention between the groups 0.0 (0.0; 0.0) versus 1.0 (0.0; 2.0) (P=0.001). Nugent score decreased during the intervention period by 5.5 (7.0;2.3) in the verum compared to 3.0 (6.0;0.5) in the control group (P=0.158). Additional intake of yoghurt containing these probiotic strains improved the recovery rate and symptoms of BV and tended to improve the vaginal microbial pattern.

Criteria for diagnosis of bacterial vaginosis using the test Femoflor-16

Background. Bacterial vaginosis is disturbance of the balance of the vaginal microflora, associated with a number of infectious diseases of the urogenital tract and adverse pregnancy outcomes. In this country, for the detection of vaginal dysbiotic conditions, the test Femoflor-16 (DNA-Technology, Moscow) is widely used, however interpretation algorithms of this test do not include the category of BV. Aim. The study aimed to elaborate diagnostic criteria for the detection of BV using Femoflor-16 test. Materials and methods. Women of reproductive age addressing a gynecologist with vaginal discharge were enrolled in the study. For clinical diagnosis of BV, the Amsel criteria were used, laboratory analysis for BV was performed via microscopic investigation of vaginal discharge using the Nugent score. Samples of vaginal discharge from all women were analyzed with the test Femoflor-16, intended for characterizing vaginal microbiocenosis using multiplex quantitative real-time PCR. Results. A total of 280 women were included in the study. BV was diagnosed in 86 women (31%) using the Amsel criteria, and in 81 women (29%) using the Nugent score. All groups of anaerobic bacteria included in Femoflor-16 test were shown to be associated with BV, with the exception of bacteria of the genus Mobiluncus, which are detected together with phylogenetically related but not BV-associated bacteria of the genus Corynebacterium. A low amount of lactobacilli (< 10% of total bacterial load) coupled with an elevated amount of Gardnerella vaginalis/Prevotella bivia/Porphyromonas (> 1%) and/or Eubacterium (> 2%) and/or Sneathia/Leptotrichia/Fusobacterium (> 0.1%) and/or Megasphaera/Veillonella/Dialister (> 0.1%) and/or Lachnobacterium/Clostridium (> 0.1%) and/or Peptostreptococcus (> 0.1%) and/or Atopobium vaginae (> 0.2%) detected BV with a sensitivity of 99% and specificity of 93%. Conclusions. Criteria for BV diagnosis using the test Femoflor-16 have been elaborated, which enable to detect BV or exclude it with a sensitivity of 99% and specificity of 93%. These criteria for BV and criteria of the test manufacturers for severe anaerobic dysbiosis determine to a large extent the same category of the vaginal microbiocenosis.

Association between bacterial vaginosis and partner concurrency: a longitudinal study

ObjectivesThe study aimed to test if there was an association between prevalent bacterial vaginosis (BV) and women reporting that their partner had other partners at the same time (partner concurrency). This association has not been assessed in a longitudinal cohort.MethodsThe Longitudinal Study of Vaginal Flora recruited a cohort of 3620 non-pregnant women aged 15–44 years who presented for routine primary healthcare at 12 clinics in Birmingham, Alabama. Behavioural questionnaires and vaginal smears were obtained quarterly for a year and BV was defined by a Nugent score 7 or higher as well as Amsel criteria. Mixed effects logistic regression was used to assess the relationship between prevalent BV and reporting that one's partner had other partners in the preceding 3–6 months time interval.ResultsNugent score prevalent BV was associated with both reporting that one's partner definitely (adjusted OR (aOR) 1.5; 95% CI 1.2 to 1.8) and possibly (aOR 1.5; 95% CI 1.2 to 1.8) engaged in partner concurrency in the preceding 3–6 months time period. Prevalent BV diagnosed by Amsel criteria was similar.ConclusionsA diagnosis of prevalent BV was associated with reporting that one's partner possibly or definitely engaged in partner concurrency.