ForD istributers

Publications

1. VI-SENSE & VS-SENSE | Over-the-counter antifungal drug misuse associated with patient-diagnosed vulvovaginal candidiasis

Ferris DG, Nyirjesy P, Sobel JD, Soper D, Pavletic A, Litaker MS.

Abstract :

OBJECTIVE: To estimate what proportion of symptomatic women purchasing over-the-counter antifungal products for immediate treatment of presumed vulvovaginal candidiasis have vulvovaginal candidiasis or other genitourinary conditions. METHODS: A time-location sample of 95 symptomatic women who purchased and presented with an over-the-counter antifungal product for immediate and personal treatment of presumed vulvovaginal candidiasis were evaluated by clinical examination and pertinent laboratory tests. The percentage of women diagnosed having vulvovaginal candidiasis or other conditions, proportions of women with vulvovaginal candidiasis compared between groups with and without a prior diagnosis of vulvovaginal candidiasis, and groups that read or did not read the over-the-counter package label were assessed. RESULTS: The actual diagnoses for women who self-diagnosed vulvovaginal candidiasis were: vulvovaginal candidiasis 33.7%, bacterial vaginosis 18.9%, mixed vaginitis 21.1%, normal 13.7%, other diagnoses 10.5%, and trichomonas vaginitis 2.1%. Women with a previous clinically based diagnosis of vulvovaginal candidiasis were not more accurate in diagnosing vulvovaginal candidiasis than women without a prior clinical diagnosis (chi(2) = 0.27, P =.6). Women who read the package label were no more likely to have vulvovaginal candidiasis than were women who did not read the label (Fisher exact test, P =.39). CONCLUSION: Many women who self-diagnose and use an over-the-counter product for treatment of presumed vulvovaginal candidiasis do not have vulvovaginal candidiasis. A history of a previous clinically based diagnosis of vulvovaginal candidiasis and reading the package label do not help women self-diagnose vulvovaginal candidiasis properly. Ready access to these products is associated with wasted financial expenditures, unfulfilled expectations, and a delay in correct diagnosis for a substantial number of women.

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2. VI-SENSE & VS-SENSE | Vaginal fluid pH as a screening test for vaginitis.

Thinkhamrop J, Lumbiganon P, Thongkrajai P, Chongsomchai C, Pakarasang M.

Abstract:

OBJECTIVE: To assess how effective the pH test can detect infectious vaginitis. METHODS: Ambulatory gynecological patients attending the gynecological out-patient department of Srinagarind Hospital from May 1 to July 31, 1997 were assessed for vaginitis by history, overall physical examination and vaginal examination. Specimens were collected for microbiological examination and measurement of pH level. RESULTS: Among 422 women recruited, a vaginal fluid pH level greater than 4.5 was found in 149 (35.3%) cases. The vaginal fluid pH as a screening test for infectious vaginitis showed a sensitivity of 49.7% (95% C.I.: 42.6-56.9). When using vaginal fluid pH combined with clinical symptoms and signs to screen for vaginitis the sensitivity was 67.5% (95% C.I.: 60.4-73.9). If a pH test was used to screen for BV, its sensitivity was 73.4% (95% C.I.; 60.7-83.3). Using a pH test in combination with clinical symptoms and signs of vaginitis to screen for BV, its sensitivity was 81.3% (95% C.I.: 69.2-89.5). CONCLUSION: Vaginal fluid pH combined with clinical symptoms and signs had a considerably high sensitivity to screen for BV.

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3. VI-SENSE & VS-SENSE | The infrequent use of office-based diagnostic tests for vaginitis.

Wiesenfeld HC, Macio I. Am J Obstet Gynecol. 1999 Jul;181(1):39-41.

Abstract :
OBJECTIVE: This study was undertaken to determine physician use of simple office-based tests in the evaluation of women with vulvovaginal symptoms. STUDY DESIGN: A medical record review of 52 women seeking care at a referral-based vaginitis clinic was performed. The evaluation performed and the care management were recorded for 150 previous physician-provided office visits. RESULTS: A microscopic assessment of vaginal fluid was not performed in 37% of office visits, and 42% of physicians did not perform microscopy as part of any evaluation of vaginitis. Whiff amine tests and measurement of vaginal pH were rarely performed (3% of office visits). Treatment without adequate evaluation of the etiology of the symptoms occurred in 54% of visits in which medication was prescribed. CONCLUSIONS: In our study population the evaluation and care provided to women presenting for evaluation of vulvovaginal symptoms were suboptimal. The use of simple inexpensive office-based tests can optimize the assessment of vaginal infections and should be encouraged.

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4. VI-SENSE & VS-SENSE | Bacterial vaginosis.

Sobel JD. Annu Rev Med. 2000;51:349-56.

Abstract :
Bacterial vaginosis represents a unique upheaval of the complex vaginal bacterial flora with disappearance of lactobacilli and overgrowth of Gardnerella vaginalis and resident anaerobic vaginal bacteria. Little progress has occurred in identifying causal factors, although the pathophysiology of this syndrome is better understood. Although symptoms are easily recognizable, obstetric and gynecologic complications continue to increase in number. Bacterial vaginosis is far more than a nuisance infection. Problems with diagnosis continue to dominate clinical practice, although new tests have been introduced. Therapeutic options have increased, although recurrent disease remains common, and management of this common complication constitutes a major challenge.

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5. AL-SENSE | Clinical significance and outcome of preterm prelabor rupture of membranes: population-based study.

Furman B, Shoham-Vardi I, Bashiri A, Erez O, Mazor M. Eur J Obstet Gynecol Reprod Biol. 2000 Oct;92(2):209-16.

Abstract:
OBJECTIVE: To evaluate maternal characteristics and neonatal and maternal birth outcome in cases of prelabor rupture of membranes (PPROM) in a non-selected parturient population. STUDY DESIGN: The study population consisted of 5660 singleton preterm births (24-36 weeks gestation) occurring between 1988 and 1997 at the Soroka University Medical Center in Israel. Parturients with no prenatal care were excluded from the study. A cross-sectional study was designed between two groups. The study group consisted of patients with PPROM (n=968) and the comparison group consisted of patients without PPROM (n=4692). The data were analyzed by SPSS package. Information was obtained using a computerized database based on detailed obstetrical records. Logistic regression was used to assess the contribution of different risk factors to PPROM. RESULTS: PPROM was associated with a significantly lower gestational age (24-32 weeks) and birth weight (<2500 g) than those with intact membranes. The rates of chorioamnionitis and urinary infection were found significantly higher in the PPROM group compared with women without PPROM (16.5 vs. 2.7%; 5.1 vs. 3.3%, respectively) (P<0.001). The rate of endometritis and bacteremia in the postpartum period were significantly higher in women with PPROM compared with controls 2.8 vs. 1.4%, (P=0.003) and 9.4 vs. 5%, (P=0.001), respectively. Total perinatal mortality rates were significantly higher in the group without PPROM 10.5 vs. 7.2% (P=0.01), however, rates of postpartum death were higher in the PPROM group 5.5 vs. 4% (P<0.01). When adjusted for recognized risk factors using logistic regression analysis, infection of amniotic fluid (OR=6.6) and genito-urinary tract infection (OR=1.64) remained the independent risk factors associated with PPROM. CONCLUSIONS: Infectious morbidity in patients with preterm prelabor rupture of membranes and preterm delivery remained an important risk factor for obstetrical and neonatal complications.

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6. AL-SENSE | Amniotic fluid volume in intra-amniotic inflammation with and without culture-proven amniotic fluid infection in preterm premature rupture of membranes.

Lee SE, Romero R, Lee SM, Yoon BH. J Perinat Med. 2010;38(1):39-44.

Abstract:
OBJECTIVE: Previous studies reported that the clinical significance of intra-amniotic inflammation with a negative amniotic fluid (AF) culture is similar to that of intra-amniotic inflammation with microbiologically-proven AF infection. However, the magnitude of the fetal inflammatory response in these two conditions is different as gauged by umbilical cord C-reactive protein (CRP) concentrations. We undertook this study to determine if the frequency of oligohydramnios is different in these two conditions. METHODS: The amniotic fluid index (AFI) was measured in 205 patients with preterm premature rupture of membranes (PROM) (23 ng/mL). Patients were divided into three groups according to the results of AF culture and the presence or absence of intra-amniotic inflammation: 1) without intra-amniotic inflammation and a negative culture (n=109); 2) with intra-amniotic inflammation and a negative culture (n=44); and 3) a positive culture (n=52). RESULTS: Patients with a positive culture had a higher frequency of oligohydramnios and a lower median AFI than those with a negative culture but with intra-amniotic inflammation (P<0.01). However, there was no significant difference in the median AFI or in the frequency of oligo-hydramnios according to the presence or absence of intra-amniotic inflammation among patients with a negative culture (P>0.1). CONCLUSION: Oligohydramnios was more frequent in patients with culture-proven AF infection than in those with intra-amniotic inflammation and a negative AF culture.

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7. AL-SENSE | Prolonged latency after preterm premature rupture of membranes: an evaluation of histologic condition and intracranial ultrasonic abnormality in the neonate born at <28 weeks of gestation.

McElrath TF, Allred EN, Leviton A Am J Obstet Gynecol. 2003 Sep;189(3):794-8.

Abstract:

OBJECTIVE: The purpose of this study was to evaluate whether infants who were delivered at <28 weeks of gestation after prolonged latency in pregnancies that were complicated by preterm premature rupture of membranes are at increased risk of histologic chorioamnionitis and intracranial ultrasound abnormalities. STUDY DESIGN: A retrospective cohort analysis of 430 singleton infants born at <28 weeks of gestation in five hospitals (January 1991 through December 1993) with at least one of three protocol cranial scans read by a consensus committee and with placental pathologic evidence. Outcome variables were placental (histologic chorioamnionitis, fetal vasculitis) and neonatal (intraventricular hemorrhage, echolucencies, ventriculomegaly). Latency was divided into five intervals, and outcomes in the longer four intervals were compared with those in infants who were delivered at <1 hour after membrane rupture. Each outcome-latency relationship was evaluated in a logistic model that was controlled for confounders. RESULTS: Odds ratios and CIs for each latency interval that was controlled for confounders that included gestational age, maternal race, antenatal steroid and antibiotic administration, and delivery mode show a statistically significant increase in the risk of histologic chorioamnionitis and fetal vasculitis. Models for intraventricular hemorrhage, ventriculomegaly, and echolucencies failed to demonstrate significant differences with increasing latency. CONCLUSIONS: Ascending transcervical infection after preterm premature rupture of membranes is documented by the increasing odds ratios of placental inflammation. The odds of ultrasonically detectable brain abnormalities, however, did not increase with increasing latency.

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8. AL-SENSE | Amniotic fluid index values after preterm premature rupture of the membranes and subsequent perinatal infection.

Vermillion ST, Kooba AM, Soper DE. Am J Obstet Gynecol. 2000 Aug;183(2):271-6.

Abstract:
OBJECTIVE: Our purpose was to determine whether an amniotic fluid index (AFI) <5 cm after preterm premature rupture of the membranes is associated with an increased risk of perinatal infection. STUDY DESIGN: We performed a nonconcurrent prospective analysis of 225 singleton pregnancies complicated by preterm premature rupture of the membranes, with delivery between 24 and 32 weeks' gestation. All included patients received 2 doses of betamethasone antenatally, in the first 24 hours after admission, and broad-spectrum antibiotic prophylaxis. Patients were categorized into 2 groups on the basis of a 4-quadrant AFI <5 cm (n = 131) or > or =5 cm (n = 94). Perinatal outcomes analyzed included latency until delivery, mode of delivery, and frequencies of clinical chorioamnionitis, postpartum endometritis, and culture-proved early neonatal sepsis. Continuous data were evaluated for normal distribution and tested for significance with the Student t test. Categoric data were tested with the chi(2) and Fisher exact tests. Multiple logistic regression analyses were performed with chorioamnionitis, endometritis, and early-onset neonatal sepsis each as the dependent variable in separate analyses. All 2-sided P values <.05 were considered significant. RESULTS: Both groups were similar with respect to selected demographics, gestational age at rupture of the membranes, birth weight, and maternal group B streptococcal colonization. Patients with an AFI <5 cm demonstrated a shorter mean latency until delivery (5.5 +/- 4.0 vs 14.1 +/- 5.2) (mean +/- SD) days (P =.02), greater frequency of amnioinfusion therapy (23.6% vs 5.3%) (P <.001), and cesarean delivery for nonreassuring fetal testing (18.3% vs 4. 3%) (P =.01). Multiple logistic regression analysis showed that an AFI <5 cm was the only significant risk factor independently associated with early-onset neonatal sepsis (P =.004) and chorioamnionitis (P =.024). CONCLUSIONS: An AFI <5 cm after preterm premature rupture of the membranes between 24 and 32 weeks' gestation is associated with an increased risk of perinatal infection and a shorter latency preceding delivery.


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9. AL-SENSE | Urinary incontinence during pregnancy.

Obstet Gynecol. 2007 Apr;109(4):922-8. Wesnes SL, Rortveit G, Bø K, Hunskaar S.

Abstract:
OBJECTIVE: To investigate incidence and prevalence of urinary incontinence during pregnancy and associated risk factors. METHODS: The data collection was conducted as part of the Norwegian Mother and Child Cohort Study at the Norwegian Institute of Public Health. We present questionnaire data about urinary incontinence obtained from 43,279 women (response rate 45%) by week 30. We report data on any incontinence, in addition to type, frequency, and amount of incontinence. Potential risk factors were investigated by logistic regression analyses. RESULTS: The prevalence of incontinence increased from 26% before pregnancy to 58% in week 30. The corresponding figures for nulliparous women were 15% and 48%, and for parous women 35% and 67%. The cumulative incidence was 46%. Stress urinary incontinence was the most common type of incontinence in week 30 of pregnancy, experienced by 31% of nulliparous and 42% of parous women. The majority of pregnant women had leakage less than once per week and droplets only, both before and during pregnancy. Parity was a strong and significant risk factor for incontinence in adjusted analyses both before pregnancy (odds ratio [OR] 2.5, 95% confidence interval [CI] 2.4-2.7 for primiparous and OR 3.3, 95% CI 3.1-3.5 for multiparous women) and during pregnancy (ORs 2.0, 95% CI 1.9-2.1 and 2.1, 95% CI 2.0-2.2, respectively). Age and body mass index were weaker, but still statistically significant, risk factors. CONCLUSION: The prevalence of urinary incontinence increases substantially during pregnancy. Incontinence both before and during pregnancy seems to be associated with parity, age, and body mass index.

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10. The VI-SENSE-vaginal discharge self-test to facilitate management of vaginal symptoms

Geva A, Bornstein J, Dan M, Shoham HK, Sobel JD. Am J Obstet Gynecol. 2006 Nov;195(5):1351-6

Abstrac:
OBJECTIVE: This study was undertaken to evaluate a diagnostic panty liner (VI-SENSE) (Common Sense, Caesarea, Israel) developed to facilitate diagnosis of vaginal infections by detecting disordered acidity level. STUDY DESIGN: Five hundred sixteen women with vulvovaginal symptoms were enrolled. Final clinical diagnosis included Amsel criteria, Gram stain analysis, pH determination, and Trichomonas vaginalis and Candida culture. VI-SENSE strip color status estimated by patients was compared with clinical diagnosis and pH measurement by using nitrazine paper. Statistical analysis included sensitivity and specificity calculations. RESULTS: The VI-SENSE test was positive in 226 of 249 patients (90.8%) with bacterial vaginosis or trichomoniasis. Nitrazine pH paper revealed elevated pH in 165 (66.5%) and the amine test was positive in 160 (64.3%) patients. The VI-SENSE test was negative in 217 of 267 patients (81.3%) without trichomoniasis or bacterial vaginosis. The VI-SENSE was positive in 85 of 92 women (92%), with mixed vaginal infection including Candida and bacterial vaginosis or trichomoniasis. Amine test, nitrazine pH paper and physician diagnosis relying only on speculum examination were inferior and positive in only 65 (70%), 59 (64%), and 66 (72%) patients, respectively. CONCLUSION: The VI-SENSE test was found to be superior to traditional individual tests in facilitating preliminary diagnosis of vaginal infections.

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11. Use of the VS-sense swab in diagnosing vulvovaginitis

Sobel JD, Nyirjesy P, Kessary H, Ferris DG. J Womens Health (Larchmt). 2009 Sep;18(9):1467-70.

Abstract:
BACKGROUND: Although pH assessment of vaginal secretions is beneficial for diagnosing vaginitis, it is not commonly done. The purpose of this study was to determine the performance characteristics of the VS-Sense (pH test) swab (Common Sense, Ltd., Caesarea, Israel) in augmenting the diagnosis of vaginitis. METHODS: We prospectively studied 193 women with acute vulvovaginal symptoms and 74 asymptomatic controls at three medical centers. The VS-Sense swab was administered intravaginally, and results were interpreted by a nurse. These results were compared with final clinical and laboratory diagnoses. RESULTS: In women with an elevated pH caused by bacterial vaginosis (BV), trichomonas, and other types of vaginitis, the VS-Sense test sensitivity and specificity were 82.3% (102 of 124) (95% CI 74.4%-88.5%) and 94.2% (129 of 137) (95% CI 88.8%-97.4%), respectively. There was an 86.2% (95% CI 81.3%-90.1%) overall agreement between pH paper and VS-Sense swab results. CONCLUSIONS: The VS-Sense test offers an alternative approach to measuring vaginal pH with nitrazine paper. Use of this simple, more rapid test may facilitate the diagnosis of vulvovaginitis.

 

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12. Nonintrusive diagnosis of premature ruptured amniotic membranes using a novel polymer

Bornstein J, Geva A, Solt I, Fait V, Schoenfeld A, Shoham HK, Sobel J. Am J Perinatol. 2006 Aug;23(6):351-4.

Abstract :
OBJECTIVE: This study investigated the reliability, sensitivity and specificity of a commercially available absorbent pad, AmnioSense, compared with speculum examination for detection of spontaneous ruptured membranes (SRM). DESIGN: Prospective cohort study. SETTING: Antenatal Day Unit (ADU) of a UK inner-city teaching hospital. POPULATION: Women attending the ADU with a history of suspected ruptured membranes between 18 and 42 weeks of gestation. METHODS: Eligible women were asked to use the absorbent pad in accordance with the manufacturer's instructions. A midwife recorded the result. A second midwife performed a speculum examination according to unit protocol. Results were entered onto a password-protected study-specific database. Both midwives were blind to the other test result. MAIN OUTCOME MEASURES: Comparability between the index test (AmnioSense) and reference standard (speculum). RESULTS: A total of 157 women were recruited and results were analysed in 139 cases. Median gestational age at recruitment was 37(+2) weeks. The prevalence of SRM was 42% (59/139) with AmnioSense giving a sensitivity of 98% (58/59) and specificity of 65% (52/80). CONCLUSIONS: Thirty-eight percent (53/139 women) with SRM would have been correctly identified as having intact membranes without the need for a speculum examination. Twenty-five percent of AmnioSense false-positive results were associated with positive high vaginal swab results (7/28). These data suggest that a negative AmnioSense result can provide reassurance of intact membranes. Use of the AmnioSense test before considering speculum examination could reduce the number of speculum examinations undertaken, with benefit to women and concomitant health resource savings.

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13. Effectiveness of a novel home-based testing device for the detection of rupture of membranes

Bornstein J, Ohel G, Sorokin Y, Reape KZ, Shnaider O, Kessary-Shoham H, Ophir E. Am J Perinatol. 2009 Jan;26(1):45-50.

Abstract :
We evaluated the ability of a testing panty liner (TPL) embedded with a pH/ammonia indicator polymer to differentiate amniotic fluid leakage from urine. A multicenter, open-label study in which 339 pregnant women (age 18 to 45 years, minimum 16 weeks' gestation, presenting with unexplained vaginal wetness) were enrolled. The TPL was worn and the results read by the subject and a health care provider (HCP) who was blinded to the subject's reading. Results were compared with the standard clinical diagnosis, as determined by direct visualization of vaginal pooling, crystallization (ferning), and nitrazine tests, performed by a second blinded HCP. Subject experience with the test was assessed with a brief questionnaire. The TPL accurately detected 154 of the 161 subjects found to have amniotic fluid leakage by the standard diagnosis; thus, the sensitivity of the TPL was 95.65%. The specificity was 84.46% (% true negative readings), as the TPL demonstrated a negative result for 125 of the 148 subjects whose clinical diagnosis was negative for amniotic fluid leakage. The overall agreement between the TPL readings of the clinician and that of the subject was 97.40%. The TPL is a reliable test to determine the presence of amniotic fluid leakage.

 

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14. Prospective cohort study investigating the reliability of the AmnioSense method for detection of spontaneous rupture of membranes

Mulhair L, Carter J, Poston L, Seed P, Briley A. BJOG. 2009 Jan;116(2):313-8.

Abstract :
OBJECTIVE: This study investigated the reliability, sensitivity and specificity of a commercially available absorbent pad, AmnioSense, compared with speculum examination for detection of spontaneous ruptured membranes (SRM). DESIGN: Prospective cohort study. SETTING: Antenatal Day Unit (ADU) of a UK inner-city teaching hospital. POPULATION: Women attending the ADU with a history of suspected ruptured membranes between 18 and 42 weeks of gestation. METHODS: Eligible women were asked to use the absorbent pad in accordance with the manufacturer's instructions. A midwife recorded the result. A second midwife performed a speculum examination according to unit protocol. Results were entered onto a password-protected study-specific database. Both midwives were blind to the other test result. MAIN OUTCOME MEASURES: Comparability between the index test (AmnioSense) and reference standard (speculum). RESULTS: A total of 157 women were recruited and results were analysed in 139 cases. Median gestational age at recruitment was 37(+2) weeks. The prevalence of SRM was 42% (59/139) with AmnioSense giving a sensitivity of 98% (58/59) and specificity of 65% (52/80). CONCLUSIONS: Thirty-eight percent (53/139 women) with SRM would have been correctly identified as having intact membranes without the need for a speculum examination. Twenty-five percent of AmnioSense false-positive results were associated with positive high vaginal swab results (7/28). These data suggest that a negative AmnioSense result can provide reassurance of intact membranes. Use of the AmnioSense test before considering speculum examination could reduce the number of speculum examinations undertaken, with benefit to women and concomitant health resource savings.

 

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