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1.  Efficacy of Clindamycin Vaginal Ovule (3-Day Treatment) vs. Clindamycin Vaginal Cream (7-Day Treatment) in Bacterial Vaginosis 
Objective: To compare the efficacy and safety of a 3-day regimen of clindamycin vaginal ovules with a 7-day regimen of clindamycin vaginal cream for the treatment of bacterial vaginosis (BV)
Methods: Women with a clinical diagnosis of BV were treated with a 3-day course of clindamycin ovules or a 7-day course of clindamycin cream administered intravaginally. Three hundred and eighty-four patients received study drug and were included in the evaluable patient population (ovule group, n = 204; cream group, n = 180). Assessments included pelvic examination and diagnostic testing. Primary efficacy endpoints were a resolution of two of three diagnostic criteria at the first follow-up visit and three of three diagnostic criteria at the second.
Results: Cure rates in the evaluable patient population were similar between treatment groups: 53.7% (109/204) for the ovule group and 47.8% (85/180) for the cream group (p = 0.2471, 95% CI– 4.1–16.0%). The most commonly reported medical event, vulvovaginal pruritus, had similar incidence in both treatment groups.
Conclusions: A 3-day course of clindamycin vaginal ovules is as effective and well-tolerated as a 7-day course of clindamycin vaginal cream in the treatment of BV.
PMCID: PMC1784633  PMID: 11368263
2.  Pathogenesis to Treatment: Preventing Preterm Birth Mediated by Infection 
Prevention of preterm birth and subsequent newborn immaturity is a primary goal of obstetrical care worldwide. Accumulated evidence shows that 1) as many as 25–50% of preterm births are caused by common genital tract infections and subsequent maternal/fetal inflammatory responses; 2) microbial and maternal host factors (phospholipases, proteases, etc.) play roles in preterm labor and preterm premature rupture of membranes (pPROM); 3) integrated aspects of maternal and fetal host responses (inflammation, altered immune adaptations, endocrine and paracrine mechanisms) play increasingly understood roles in premature activation of parturition; and 4) identification and systemic treatment of common genitourinary infections, most importantly bacterial vaginosis (BV), reduce the risks of preterm delivery and PROM.
PMCID: PMC2364559  PMID: 18476162
3.  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).
Methods: In a double-blinded study, 247 women with symptomatic BV were randomly assigned to receive either 5 g of 0.75% metronidazole gel twice daily for 5 days or triple-sulfa cream twice daily for 5 days. There were 205 (96 treated with metronidazole and 109 treated with triple-sulfa) evaluable patients to compare efficacy at the final visit. Approximately 60% of these patients had been previously treated for BV, reflecting the recurrent nature of the disease in this patient population.
Results: At the first (12–16 days) return visit, 81/103 (79%) patients in the metronidazole group were cured compared with 80/113 (71%) patients in the triple-sulfa cream group (P = 0.333). At the final (28–35 days) return visit, 63/96 (66%) in the 96 metronidazole group remained cured compared with only 51/109 (47%) in the triple-sulfa group (P = 0.02). An intent-to-treat analysis similarly showed that the cure rate with metronidazole was superior to triple-sulfa (P ≤ 0.02). The clinical diagnosis demonstrated a high correlation (88%) with the diagnosis made by an independent assessment by Gram's stain. The side effects reported by the patients using metronidazole gel were infrequent and mild and were similar to those reported with triple-sulfa.
Conclusions: Metronidazole gel is a safe, effective, and well-tolerated treatment for BV.
PMCID: PMC2364475  PMID: 18476069
4.  Trichomonas vaginalis Weakens Human Amniochorion in an In Vitro Model of Premature Membrane Rupture 
Objective: Trichomonas vaginalis (TV) infection is associated with preterm rupture of membranes (PROM) and preterm birth. We evaluated the effects of TV growth and metabolism on preparations of human amniochorion to understand and characterize how TV may impair fetal-membrane integrity and predispose to PROM and preterm birth.
Methods: Term fetal membranes were evaluated using an established in vitro fetal-membrane model. Fresh TV clinical isolates were obtained from pregnant women. The protozoa (5.0×105 to 1.5×106/ml) were incubated with fetal membranes in modified Diamond's medium for 20 h at 37°C in 5% CO2.The effects of fetal-membrane strength (bursting tension, work to rupture, and elasticity) were measured using a calibrated Wheatstone-bridge dynamometer. Tests were also performed to evaluate the effects of 1) inoculum size; 2) metronidazole (50 μg/ml); and 3) cell-free filtrate.
Results: The TV-induced membrane effects were 1) isolate variable; 2) inoculum dependent; 3) incompletely protected by metronidazole; and 4) mediated by both live organisms as well as protozoan-free culture filtrates. Six of 9 isolates significantly reduced the calculated work to rupture (P ≤ 0.02); 7 of 9 reduced bursting tension; and 1 of 9 reduced elasticity. One isolate significantly increased the work to rupture and bursting tension (P ≤ 0.002).
Conclusions: In vitro incubation of fetal membranes with TV can significantly impair the measures of fetal-membrane strength. This model may be used to delineate the mechanisms of TV-induced membrane damage. This study suggests that there are enzyme-specific effects as well as pH effects.
PMCID: PMC2364407  PMID: 18475407
5.  Trichomonas vaginalis: Diagnosis and Clinical Characteristics in Pregnancy 
Objective: The objectives of this study were to 1) determine the prevalance and characterize the symptomatology of Trichomonas vaginalis (TV) infection in pregnant women on entry into prenatal care in an inner-city population; 2) compare conventional microscopic methods vs. culture techniques in diagnosing TV in both symptomatic and asymptomatic pregnant patients; and 3) correlate wet mount microscopic and microbiologic characteristics of varying manifestations of trichomoniasis.
Methods: One thousand two hundred sixty patients in an inner-city population were tested at entry into prenatal care for TV by saline wet mount and culture techniques. Other tests for lower genital tract infection were also performed. Vaginal symptoms were ascertained through standardized questioning prior to examination. Standard microscopic and microbiologic data were also obtained for analysis. Wet mounts were systematically examined and considered negative if no TV was identified in 10 high powerfields (HPFs). Cultures were inspected from days 4 to 7 or until positive results were obtained. Results were analyzed using McNemar's test for correlated proportions, chi-squared test, or Fisher exact test where appropriate.
Results: Culture and wet mount results were available in 1,175 patients. TV infection was documented by one or both techniques in 110/1,175 (9.4%). Culture methods detected 105/110 (94.5%) of all patients while wet mount detected 90/110 (73%) (P <0.001). Vaginal symptoms were present in only 20/110 patents (18.2%). Among asymptomatic patients, culture detected 94% while wet mount detected 70% (P < 0.001). Among symptomatic patients, wet mount and culture were both effective and diagnosed 85% and 95% of infections, respectively (P = not significant). Patients with TV were more likely to have increased vaginal fluid wlaite blood cells (WBCs) and more severe vaginal flora disruption than uninfected controls. Subgroup analysis revealed wet mount-positive/culture-positive patients were more likely to have vaginal flora disruption, as evidenced by decreased lactobacilli and elevated vaginal pH, than wet mount-negative/culture-positive subjects. Coexistent infection rates were similar regardless of wet mount status. Elevated vaginal fluid WBCs were more common among patients with symptoms.
Conclusions: 1) Screening pregnant women for TV based solely on symptomatology is ineffective in this population; 2) culture techniques detected more infections than conventional microscopic evaluation; and 3) significant increases in vaginal fluid WBCs and altered vaginal flora are found in both symptomatic and asymptomatic TV, suggesting that both infestations have the potential to adversely affect pregnancy outcome. Studies on the influence of TV on pregnancy outcomes are ongoing.
PMCID: PMC2366141  PMID: 18472879

Results 1-5 (5)