Congenital infection with human cytomegalovirus (CMV) is a major cause of morbidity and mortality. In an uncontrolled study published in 2005, administration of CMV-specific hyperimmune globulin to pregnant women with primary CMV infection\ud significantly reduced the rate of intrauterine transmission, from 40% to 16%. Methods: We evaluated the efficacy of hyperimmune globulin in a phase 2, randomized, placebo-controlled, double-blind study. A total of 124 pregnant women with primary\ud CMV infection at 5 to 26 weeks of gestation were randomly assigned within 6 weeks after the presumed onset of infection to receive hyperimmune globulin or placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid. The primary end point was congenital infection diagnosed at birth\ud or by means of amniocentesis. Results: A total of 123 women could be evaluated in the efficacy analysis (1 woman in the\ud placebo group withdrew). The rate of congenital infection was 30% (18 fetuses or infants of 61 women) in the hyperimmune globulin group and 44% (27 fetuses or infants of 62 women) in the placebo group (a difference of 14 percentage points; 95% confidence interval, −3 to 31; P = 0.13). There was no significant difference\ud between the two groups or, within each group, between the women who transmitted the virus and those who did not, with respect to levels of virus-specific antibodies, T-cell–mediated immune response, or viral DNA in the blood. The clinical\ud outcome of congenital infection at birth was similar in the two groups. The number of obstetrical adverse events was higher in the hyperimmune globulin group than in the placebo group (13% vs. 2%). Conclusions: In this study involving 123 women who could be evaluated, treatment with hyperimmune globulin did not significantly modify the course of primary CMV infection during pregnancy. (Funded by Agenzia Italiana del Farmaco; CHIP ClinicalTrials.gov number, NCT00881517; EudraCT no. 2008-006560-11.

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Objective To explore the attitudes of obstetricians to performe a caesarean section on maternal request in the absence of medical indication.Design Cluster sampling cross-sectional survey.Setting Neonatal Intensive Care Unit (NICU) associated maternity units in eight European countries.Population Obstetricians with at least 6 months clinical experience.Methods NICU-associated maternity units were chosen by census in Luxembourg, Netherlands and Sweden and by geographically stratified random sampling in France, Germany, Italy, Spain and UK. An anonymous, self-administered questionnaire was used for data collection.Main outcome measures Obstetricians' willingness to perform a caesarean section on maternal request.Results One hundred and five units and 1530 obstetricians participated in the study (response rates of 70 and 77%, respectively). Compliance with a hypothetical woman's request for elective caesarean section simply because it was 'her choice' was lowest in Spain (15%), France (19%) and Netherlands (22%); highest in Germany (75%) and UK (79%) and intermediate in the remaining countries. Using weighted multivariate logistic regression, country of practice (P < 0.001), fear of litigation (P = 0.004) and working in a university-affiliated hospital (P = 0.001) were associated with physicians' likelihood to agree to patient's request. The subset of female doctors with children was less likely to agree (OR 0.29,).Conclusions The differences in obstetricians' attitudes are not founded on concrete medical evidence. Cultural factors, legal liability and variables linked to the specific perinatal care organisation of the various countries play a role. Greater emphasis should be placed on understanding the motivation, values and fears underlying a woman's request for elective caesarean delivery.

Our aim was to evaluate the prevalence of bacterial vaginosis and decrease in lactobacillus colonization in women 40 years old or older in relation to menopausal status by evaluation of Gram-stained smears. A total of 1,486 smears from Italian Caucasian women aged 40 to 79 years were examined. Women were classified as follows: fertile (regular cycles) (n ‫؍‬ 328), perimenopausal (irregular cycles) (n ‫؍‬ 237), and postmenopausal (n ‫؍‬ 921), including 331 women on estroprogestinic hormone replacement therapy (HRT). The prevalences of bacterial vaginosis (assessed as a Nugent score of >7) in fertile (9.8%) and perimenopausal (11.0%) women were not statistically different, whereas the prevalence was significantly lower overall in postmenopausal women (6.0%) (P ‫؍‬ 0.02). Specifically Bacterial vaginosis (BV) is a polymicrobial disorder characterized by an increase in the vaginal pH over 4.5, a reduction in or absence of lactobacillus colonization, and overgrowth of several facultatively and obligately anaerobic bacteria (10). BV is associated with adverse pregnancy outcomes, upper genital tract infections such as pelvic inflammatory disease, endometritis, post-gynecologic-surgery infections, cervicitis, urinary tract infections, cervical intraepithelial neoplasia, and increased risk of sexual acquisition of human immunodeficiency virus infection (7,13,16,17,19,24,25,(29)(30)(31). BV is usually diagnosed by the clinical Amsel's criteria (1) or by the Nugent method (26) of Gram stain interpretation. Both these methods, however, were developed to analyze the vaginal flora of pregnant women, and then their use was extended to evaluation of the vagina flora of fertile women. To our knowledge, no clear indications on how to diagnose vaginal flora alterations in peri-and postmenopausal women have been reported. In fact, in postmenopausal women BV cannot be clinically diagnosed by Amsel's criteria (1) because one of these criteria, the vaginal pH value, is constitutively elevated (3, 23); moreover, the scarcity of vaginal discharge makes it difficult to judge the kind of secretion. The Nugent method is based on the assumption that normal women have full vaginal colonization by lactobacilli (26); this is valid for pregnant and fertile women but not for postmenopausal women (3,15,23).Very few studies have evaluated the prevalence of BV in postmenopausal women (3, 15), and no study has assessed the prevalence of BV in perimenopausal women. Moreover, no data are available on the effect of hormone replacement therapy (HRT) on BV prevalence.The present study is a cohort study to determine the changes in vaginal flora and the prevalence of BV by standardized evaluation of Gram-stained smears for women 40 years old or older as a function of reproductive condition: fertile, perimenopausal, or postmenopausal with or without HRT. MATERIALS AND METHODSStudy population. Nonpregnant women aged 40 to 79 years were consecutively recruited during routine gynecologic examinations (Papanicolaou [Pap] smear tests) in three clinics (located i...

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Vaginal innate immunity in response to microbial perturbation is still poorly understood and could be crucial for protection from adverse outcomes. We investigated the relationship between interleukin (IL)-8, IL-1beta and neutrophils in vaginal fluid obtained from 60 healthy women and 51 women who were bacterial vaginosis (BV) positive. Concentrations of IL-8 and IL-1beta were highly correlated with counts of neutrophils in vaginal fluid of the entire population examined (111 subjects). Vaginal IL-1beta concentrations were significantly higher (P < 0.001) in BV positive women. There was no significant difference in IL-8 levels or number of neutrophils between healthy controls and BV positive women. None of the healthy controls with high neutrophil counts (> or =75th percentile, 14 average count per field) had high concentrations of IL-1beta (> or =75th percentile, 220 pg/ml), whereas 84% of BV positive women with high neutrophil counts had high IL-1beta concentrations (P < 0.001). On the contrary, no difference in the percentage of subjects with elevated concentrations of IL-8 (> or =75th percentile, 2842 pg/ml) was found between healthy and BV positive women with high numbers of neutrophils (55.5% of healthy versus 53% of BV positive women). Our findings show that BV causes a large increase in IL-1beta concentrations which is not paralleled by an increase in IL-8 concentrations in vaginal fluid, suggesting that BV-associated factors more specifically dampen IL-8 rather than IL-1beta. The lack of an increase in IL-8 may explain the absence of an increase in neutrophil numbers in most women exposed to abnormal vaginal colonization (BV).

Summary:Approximately three-quarters of all women will experience an episode of vulvovaginal candidosis at least once in their life and 5± 10% of them will have more than one attack. Women suffering from three to four attacks within 12 months will be diagnosed with recurrent vulvovaginal candidosis (RVVC). This review covers the large number of proposed aetiological factors for RVVC. The diagnosis of the condition made by conventional means by health providers is often false and is also often misdiagnosed by the affected woman herself. The review covers various methods of diagnosing RVVC and the current knowledge on potential pathogenetic mechanisms proposed for genital candida infections. Treatment of RVVC, including local and systemic antimicrobial therapy and behaviour modi® cation to decrease the risk of recurrences, are discussed. Recent knowledge on drug resistance in candida is also included.

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