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Please cite this paper as: Lamont R, Sobel J, Akins R, Hassan S, Chaiworapongsa T, Kusanovic J, Romero R. The vaginal microbiome: new information about genital tract flora using molecular based techniques. BJOG 2011;118:533-549. Vaginal microbiome studies provide information that may change the way we define vaginal flora. Normal flora appears dominated by one or two species of Lactobacillus. Significant numbers of healthy women lack appreciable numbers of vaginal lactobacilli. Bacterial vaginosis (BV) is not a single entity, but instead consists of different bacterial communities or profiles of greater microbial diversity than is evident from cultivation-dependent studies. BV should be considered a syndrome of variable composition that results in different symptoms, phenotypical outcomes, and responses to different antibiotic regimens. This information may help to elucidate the link between BV and infection-related adverse outcomes of pregnancy. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess the quality of studies of nifedipine used to treat spontaneous preterm labor. DESIGN: A systematic review of study quality using a novel validity assessment tool, examining method-specific and topic-specific items in the domains of selection, performance and measurement biases. DATA SOURCES: Medline (1996-2003), EMBASE (1996-2003), BIOSIS (1993-2003), Current Contents (1995-2003), DERWENT DRUGFILE (1983-2003), Cochrane Database of Systematic Reviews. Bibliographies of existing meta-analyses and systematic reviews of nifedipine as a tocolytic. METHODS OF STUDY SELECTION: Forty-five studies evaluating the effectiveness of nifedipine were identified. DATA EXTRACTION: Each study was assessed for 40 method-specific and topic-specific items of quality in duplicate using piloted data extraction forms. Disagreements between assessors were settled by consensus/arbitration. DATA SYNTHESIS: Very few of the studies complied with adequacy criteria of quality for either method-specific or topic-specific items. There was no improvement in quality over time. The quality of method-specific items was significantly poorer when compared with topic-specific items of quality overall (P<0.0001) and in the domains of selection bias (P<0.0001) and performance bias (P<0.0001). CONCLUSION: Studies of the effectiveness of nifedipine as a tocolytic are of poorer quality with respect to method-specific items than topic-specific items. These deficiencies should be highlighted in meta-analyses or systematic reviews which measure efficacy and should influence the generation of guideline statements or recommendations for the use of nifedipine as a tocolytic. A large randomized trial fulfilling the quality items is necessary to assess the real efficacy of nifedipine in preterm labor. [ABSTRACT FROM AUTHOR]

Objective: To assess the ability of clindamycin vaginal cream to reduce the incidence of preterm birth in women with abnormal genital tract flora in the second trimester of pregnancy.Methods: This was a randomized, double-blind, placebo-controlled, tricenter study. A total of 409 women with abnormal genital tract flora on Gram stain of vaginal secretions at 13-20 weeks' gestation were randomized to receive a 3-day course of clindamycin vaginal cream or placebo. Those women who still had abnormal vaginal flora 3 weeks later received a 7-day course of the original study drug (ie, either clindamycin vaginal cream or placebo as per original randomization). The primary outcome measure was the incidence of preterm birth.Results: There was a statistically significant reduction in the incidence of preterm birth in the clindamycin vaginal cream group (4%) compared with placebo (10%) (P <.03). Significantly more babies born preterm (63%) required admission to the neonatal intensive care unit compared with term infants (4%) (P <.001).Conclusion: A 2% clindamycin vaginal cream, when compared with placebo administered to women with abnormal genital tract flora before 20 weeks' gestation, can reduce the incidence of preterm birth by 60% and hence the need for neonatal intensive care. [ABSTRACT FROM AUTHOR]

Effect of prophylactic negative pressure wound therapy vs standard wound dressing on surgical-site infection in obese women after cesarean delivery: a randomized clinical trial. Further debate about the effect of incisional negative pressure wound therapy (iNPWT) versus standard wound dressing on surgical-site infection (SSI) in obese women after caesarean section (CS) has resurfaced. [Extracted from the article]

A letter to the editor is presented in response to the article related to the treatment of bacterial vaginosis (BV) in pregnancy in the previous issue.

A response by Donders GG, Van Calsteran K, Bellen G, Reybrouck R, Vanden Bosch T, and Riphagen I to a letter to the editor about the article "The role of bacterial vaginosis, aerobic vaginitis, abnormal vaginal flora and the risk of preterm birth" in the September 2, 2009 issue is presented.

Objective The aim of this study was to describe the use of antibiotics in a national population-based cohort of pregnant Danish women between 2000 and 2010. Design Register-based, population-wide, cohort study. Setting Denmark, from 2000 to 2010. Population All pregnancies among Danish residents during the period 2000-2010 were included for analysis. Methods Data were obtained from the Danish Medical Birth Registry, the Danish National Patient Registry, and the Registry of Medicinal Product Statistics. The filled prescriptions for systemic antibacterial, antimycotic, and antiviral drugs, as well as intravaginally applied antibiotics, were analysed. Associations with demographic variables were assessed using multivariate analysis. Main outcome measures Filled prescriptions for antibiotic drugs during pregnancy. Results We included 987 973 pregnancies in Denmark from 2000 to 2010; 38.9% of women with a delivery and 14.8% of women with a miscarriage or termination of pregnancy had one or more antibiotic treatments during pregnancy. Systemic antibacterial drugs were the most frequently used drug group, with filled prescriptions for 33.4% of all deliveries and 12.6% of all abortions. This proportion increased from 28.4% in 2000 to 37.0% in 2010 among deliveries. The biggest change was seen for pivmecillinam, which increased among deliveries from 6.3% in 2000 to 19.5% in 2010. Obese (odds ratio 1.51; 95% CI 1.47-1.56), young (odds ratio 1.35; 95% CI 1.30-1.39), and low-educated women (odds ratio 1.37; 95% CI 1.35-1.1.39) tended to fill more prescriptions of antibiotics during pregnancy. Conclusions Overall, the number of women who filled prescriptions of antibiotics increased during the 11-year study period. In 2010, at least 41.5% of all deliveries were exposed to antibiotic therapy during pregnancy. [ABSTRACT FROM AUTHOR]

Objective: To estimate the rates of meconium-stained amniotic fluid (AF) and adverse outcome in relation to gestational age and racial group, and to investigate the predictors of meconium-stained AF.Methods: We studied 499,096 singleton births weighing at least 500 g, at 24 or more weeks of gestation, from 1988 to 2000. The predictors of meconium-stained AF from 37 weeks of gestation onward were determined using multiple logistic regression.Results: The crude meconium-stained AF rates in preterm, term, and postterm births were 5.1% (95% confidence interval [CI] 4.9-5.4), 16.5% (95% CI 16.4-16.6), and 27.1% (95% CI 26.5-27.6), respectively; the rates in blacks, South Asians, and whites were 22.6% (95% CI 22.2-23.1), 16.8% (95% CI 16.5-17.1), and 15.7% (95% CI 15.6-15.8), respectively. Independent predictors of meconium-stained AF included being black (odds ratio [OR] 8.4, 95% CI 2.4-28.8), vaginal breech delivery (OR 4.7, 95% CI 4.2-5.3), being South Asian (OR 3.3, 95% CI 1.3-8.3), and being in an advancing week of gestation (OR 1.39, 95% CI 1.38-1.40). More blacks (17.9%, 95% CI 17.3-18.4) and South Asians (11.8%, 95% CI 11.5-12.1) with good outcome and no risk factors for fetal hypoxia had meconium-stained AF than did whites (11.2%, 95% CI 11.1-11.4). Using white neonates born at 40 weeks as reference, the absolute risk of adverse outcome at 41 and 42 weeks were 2% and 5% in whites, 3% and 7%, in South Asians, and 7% and 11% in blacks.Conclusion: Meconium-stained AF rates are different among races and across gestational age, and overall risk of adverse outcomes in meconium stained AF is low.Level Of Evidence: II. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the cost‐effectiveness of incisional negative pressure wound therapy (iNPWT) in preventing surgical site infection in obese women after caesarean section. Design: A cost‐effectiveness analysis conducted alongside a clinical trial. Setting: Five obstetric departments in Denmark. Population: Women with a pregestational body mass index (BMI) ≥30 kg/m2. Method: We used data from a randomised controlled trial of 876 obese women who underwent elective or emergency caesarean section and were subsequently treated with iNPWT (n = 432) or a standard dressing (n = 444). Costs were estimated using data from four Danish National Databases and analysed from a healthcare perspective with a time horizon of 3 months after birth. Main outcome measures: Cost‐effectiveness based on incremental cost per surgical site infection avoided and per quality‐adjusted life‐year (QALY) gained. Results: The total healthcare costs per woman were €5793.60 for iNPWT and €5840.89 for standard dressings. Incisional NPWT was the dominant strategy because it was both less expensive and more effective; however, no statistically significant difference was found for costs or QALYs. At a willingness‐to‐pay threshold of €30,000, the probability of the intervention being cost‐effective was 92.8%. A subgroup analysis stratifying by BMI shows that the cost saving of the intervention was mainly driven by the benefit to women with a pre‐pregnancy BMI ≥35 kg/m2. Conclusion: Incisional NPWT appears to be cost saving compared with standard dressings but this finding is not statistically significant. The cost savings were primarily found in women with a pre‐pregnancy BMI ≥35 kg/m2. Prophylactic incisional NPWT reduces the risk of SSI after caesarean section and is probably dominant compared with standard dressings #healtheconomics. Prophylactic incisional NPWT reduces the risk of SSI after caesarean section and is probably dominant compared with standard dressings #healtheconomics. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the reduction of surgical site infections by prophylactic incisional negative pressure wound therapy compared with standard postoperative dressings in obese women giving birth by caesarean section. Design: Multicentre randomised controlled trial. Setting: Five hospitals in Denmark. Population: Obese women (prepregnancy body mass index (BMI) ≥30 kg/m2) undergoing elective or emergency caesarean section. Method: The participants were randomly assigned to incisional negative pressure wound therapy or a standard dressing after caesarean section and analysed by intention‐to‐treat. Blinding was not possible due to the nature of the intervention. Main outcome measures: The primary outcome was surgical site infection requiring antibiotic treatment within the first 30 days after surgery. Secondary outcomes included wound exudate, dehiscence and health‐related quality of life. Results: Incisional negative pressure wound therapy was applied to 432 women and 444 women had a standard dressing. Demographics were similar between groups. Surgical site infection occurred in 20 (4.6%) women treated with incisional negative pressure wound therapy and in 41 (9.2%) women treated with a standard dressing (relative risk 0.50, 95% CI 0.30–0.84; number needed to treat 22; P = 0.007). The effect remained statistically significant when adjusted for BMI and other potential risk factors. Incisional negative pressure wound therapy significantly reduced wound exudate whereas no difference was found for dehiscence and quality of life between the two groups. Conclusion: Prophylactic use of incisional negative pressure wound therapy reduced the risk of surgical site infection in obese women giving birth by caesarean section. RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI. RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI. [ABSTRACT FROM AUTHOR]

The article discusses a study on second victims who are healthcare professionals (HCPs) involved in an unexpected adverse event such as a medical error or a patient-related injury and have become victimized and traumatized by the event. Topics discussed include the Danish Act on Patient Safety, feelings of guilt, anger, frustration, and fear of continued practice among HCPs, and the benefits of second-victim support programmes for medical staffs and patients.

A letter to the editor is presented in response to the article related to risk of preterm labour in the Great Britain, in the previous issue.

Objective: Intrauterine devices (IUDs) are used for contraception worldwide; however, the management of pregnancies with an IUD poses a clinical challenge. The purpose of this study was to determine the outcome of pregnancy in patients with an IUD. Study design: A retrospective cohort study (December 1997-June 2007) was conducted. The cohort consisted of 12,297 pregnancies, of which 196 had an IUD. Only singleton pregnancies were included. Logistic regression analysis was used to adjust for potential confounders between the groups. Results: 1) Pregnancies with an IUD were associated with a higher rate of late miscarriage, preterm delivery, vaginal bleeding, clinical chorioamnionitis, and placental abruption than those without an IUD; 2) among patients with available histologic examination of the placenta, the rate of histologic chorioamnionitis and/or funisitis was higher in patients with an IUD than in those without an IUD (54.2% vs. 14.7%; P<0.001). Similarly, among patients who underwent an amniocentesis, the prevalence of microbial invasion of the amniotic cavity (MIAC) was also higher in pregnant women with an IUD than in those without an IUD (45.9% vs. 8.8%; P<0.001); and 3) intra-amniotic infection caused by Candida species was more frequently present in pregnancies with an IUD than in those without an IUD (31.1% vs. 6.3%; P<0.001). Conclusion: Pregnant women with an IUD are at a very high risk for adverse pregnancy outcomes. This finding can be attributed, at least in part, to the high prevalence of intra-amniotic infection and placental inflammatory lesions observed in pregnancies with an IUD. [ABSTRACT FROM AUTHOR]

A response from the author of the article "Timing of Antibiotic Prophylaxis for Caesarean Section" is presented.