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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.

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]

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]

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.

Introduction: Obstetric violence, or mistreatment of women in obstetric care, can have severe consequences such as fear of future childbirth, post-traumatic stress disorder, and depression., Material and Methods: The primary objective was to estimate the prevalence of obstetric violence in high-income countries. The secondary objective was to extract the main domains of obstetric violence perceived by women from qualitative studies. Following prospective registration (PROSPERO CRD42023468570), PubMed, Web of Science, Scopus, CINAHL, Embase, and Cochrane Library were searched with no restrictions. Included studies were cross-sectional, cohort, mixed methods, and qualitative studies based on populations from high-income countries. The review was conducted by two independent reviewers. Risk of bias was assessed. Rates of obstetric violence were pooled using random effects model, computing 95% confidence intervals (CI) and assessing heterogeneity using I 2 statistic. Funnel plots and Egger's test were used to detect potential reporting biases and small-study effects., Results: Of the 1821 records screened, 25 studies were included: 14 quantitative and 2 mixed methods studies, comprising 60 987 women, and 9 qualitative studies were included, comprising an additional 4356 women. 81.25% of quantitative studies, including the quantitative component of the mixed methods studies, were considered satisfactory or better regarding risk of bias. The prevalence of obstetric violence was overall 45.3% (95% CI 27.5-63.0; I 2  = 100.0%). The prevalence of specific forms of mistreatment was also estimated. Lack of access to analgesia was 17.3% (95% CI 6.9-27.7; I 2  = 99.7%). Ignored requests for help was 19.2% (95% CI 11.7-26.6; I 2  = 99.0%). Shouting and scolding 19.7% (95% CI 13.0-26.4; I 2  = 98.7%). The use of fundal pressure during the second stage of labor (Kristeller maneuver) was 30.3% (95% CI 22.1-38.5; I 2  = 97.6%). There was no funnel asymmetry. Lack of information and/or consent were the most frequent domains extracted from the qualitative articles and the qualitative component of the mixed methods studies., Conclusions: The results demonstrate that obstetric violence is a prevalent problem that women in high-income countries experience. Lack of information and/or consent were the domains most frequently described in the qualitative studies and the qualitative component of the mixed methods studies., (© 2024 The Author(s). Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

The manuscript disputes the exclusive mono-infectious way of thinking, which presumes that for every infection only one pathogen is responsible and sufficient, when infectious vectors, close contact and reduced immunity meet. In situations involving heavily colonized anatomical sites such an approach often ends in insoluble contradictions. Upon critical reflection and evaluation of 20 years research on spatial organization of vaginal microbiota it is apparent, that in some situations, pathogens may act and operate in permanent, structurally organized consortia, whereas its individual components may be innocuous and innocent, failing to express any pathogenic effect. In these cases, consortia are the true pathogens responsible for many infectious conditions, which usually remain unrecognized as long as improperly diagnosed. The structure of such consortia can be unraveled using ribosomal fluorescence in situ hybridization (FISH). FISH methodology, that not only offers an ex vivo opportunity to recognize bacterial species, but provides unique physical insight into their specific role in the pathogenesis of polymicrobial infections. Ribosomal FISH technique applied to both, women with bacterial vaginosis (BV) and their male partners, has added significantly to our understanding of the pathogenesis of this condition and contributed to appreciating the mechanisms of polymicrobial, community-based infection, potentially leading to therapeutic advances., Competing Interests: Declaration of competing interest The authors have no conflict of interest (including financial commitments or ethical concerns). The data of this publication were not presented previously. The work has not been published previously and is not under consideration for publication elsewhere. No generative artificial intelligence was used. The publication is approved by all authors and tacitly or explicitly by the responsible authorities where the work was carried out. If accepted, it will not be published elsewhere in the same form, in English or in any other language, including electronically without the written consent of the copyright-holder., (Copyright © 2024. Published by Elsevier Masson SAS.)

Introduction: Phthalates freely cross the placenta and have the potential to influence pregnancy outcomes, with evidence of an increased incidence of preterm birth, low birth weight, pregnancy loss, and gestational diabetes. There is no regulation of phthalate concentrations in medications, which is often found in enteric coatings. Ingestion of phthalate containing medication during pregnancy may result in materno-fetal harm., Areas Covered: Phthalate subtypes, sources of phthalate exposure, mechanisms of phthalate toxicity, associations between phthalate exposure and incidence of preterm birth, low birth weight, fetal growth, gestational diabetes, and placental development., Expert Opinion: There is robust evidence to link exposure to phthalates in medical products including preterm birth, gestational diabetes, pregnancy-induced hypertension, and miscarriage. Nevertheless, future studies need to address standardization to avoid the heterogeneity of current studies. In future, the use of naturally occurring biopolymers may be safer, and the role of vitamin D as an immune modulator also has promise.