Skin preparation for preventing infection following caesarean section.

BACKGROUND: The risk of maternal mortality and morbidity is higher after caesarean section than for vaginal birth. With increasing rates of caesarean section, it is important to minimise risks to the mother as much as possible. This review focused on different skin preparations to prevent infection. This is an update of a review last published in 2018. OBJECTIVES: To compare the effects of different antiseptic agents, different methods of application, or different forms of antiseptic used for preoperative skin preparation for preventing postcaesarean infection. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 July 2019), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised trials, evaluating any type of preoperative skin preparation (agents, methods or forms). We included studies presented only as abstracts, if there was enough information to assess risk of bias. Comparisons of interest in this review were between: different antiseptic agents (e.g. alcohol, povidone iodine), different methods of antiseptic application (e.g. scrub, paint, drape), different forms of antiseptic (e.g. powder, liquid), and also between different packages of skin preparation including a mix of agents and methods, such as a plastic incisional drape, which may or may not be impregnated with antiseptic agents. We mainly focused on the comparison between different agents, with and without the use of drapes. Only studies involving the preparation of the incision area were included. This review did not cover studies of preoperative handwashing by the surgical team or preoperative bathing. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed all potential studies for inclusion, assessed risk of bias, extracted the data and checked data for accuracy. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 13 individually-randomised controlled trials (RCTs), with a total of 6938 women who were undergoing caesarean section. Twelve trials (6916 women) contributed data to this review. The trial dates ranged from 1983 to 2016. Six trials were conducted in the USA, and the remainder in India, Egypt, Nigeria, South Africa, France, Denmark, and Indonesia. The included studies were broadly at low risk of bias for most domains, although high risk of detection bias raised some specific concerns in a number of studies. Length of stay was only reported in one comparison. Antiseptic agents Parachlorometaxylenol with iodine versus iodine alone We are uncertain whether parachlorometaxylenol with iodine made any difference to the incidence of surgical site infection (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.04 to 2.99; 1 trial, 50 women), or endometritis (RR 0.88, 95% CI 0.56 to 1.38; 1 trial, 50 women) when compared with iodine alone, because the certainty of the evidence was very low. Adverse events (maternal or neonatal) were not reported. Chlorhexidine gluconate versus povidone iodine Moderate-certainty evidence suggested that chlorhexidine gluconate, when compared with povidone iodine, probably slightly reduces the incidence of surgical site infection (RR 0.72, 95% CI 0.58 to 0.91; 8 trials, 4323 women). This effect was still present in a sensitivity analysis after removing four trials at high risk of bias for outcome assessment (RR 0.87, 95% CI 0.62 to 1.23; 4 trials, 2037 women). Low-certainty evidence indicated that chlorhexidine gluconate, when compared with povidone iodine, may make little or no difference to the incidence of endometritis (RR 0.95, 95% CI 0.49 to 1.86; 3 trials, 2484 women). It is uncertain whether chlorhexidine gluconate reduces maternal skin irritation or allergic skin reaction (RR 0.64, 95% CI 0.28 to 1.46; 3 trials, 1926 women; very low certainty evidence). One small study (60 women) reported reduced bacterial growth at 18 hours after caesarean section for women who had chlorhexidine gluconate preparation compared with women who had povidone iodine preparation (RR 0.23, 95% CI 0.07 to 0.70). Methods Drape versus no drape This comparison investigated the use of drape versus no drape, following preparation of the skin with antiseptics. Low-certainty evidence suggested that using a drape before surgery compared with no drape, may make little or no difference to the incidence of surgical site infection (RR 1.29, 95% confidence interval (CI) 0.97 to 1.71; 3 trials, 1373 women), and probably makes little or no difference to the length of stay in the hospital (mean difference (MD) 0.10 days, 95% CI -0.27 to 0.46; 1 trial, 603 women; moderate-certainty evidence). One trial compared an alcohol scrub and iodophor drape with a five-minute iodophor scrub only, and reported no surgical site infection in either group (79 women, very-low certainty evidence). We were uncertain whether the combination of a one-minute alcohol scrub and a drape reduced the incidence of metritis when compared with a five-minute scrub, because the certainty of the evidence was very low (RR 1.62, 95% CI 0.29 to 9.16; 1 trial, 79 women). The studies did not report on adverse events (maternal or neonatal). AUTHORS' CONCLUSIONS: Moderate-certainty evidence suggests that preparing the skin with chlorhexidine gluconate before caesarean section is probably slightly more effective at reducing the incidence of surgical site infection in comparison to povidone iodine. For other outcomes examined there was insufficient evidence available from the included RCTs. Most of the evidence in this review was deemed to be very low or low certainty. This means that for most findings, our confidence in any evidence of an intervention effect is limited, and indicates the need for more high-quality research. Therefore, it is not yet clear what sort of skin preparation may be most effective for preventing postcaesarean surgical site infection, or for reducing other undesirable outcomes for mother and baby. Well-designed RCTs, with larger sample sizes are needed. High-priority questions include comparing types of antiseptic (especially iodine versus chlorhexidine), and application methods (scrubbing, swabbing, or draping). We found two studies that are ongoing; we will incorporate the results of these studies in future updates of this review.

Efficacy of daikenchuto, a traditional Japanese Kampo medicine, for postoperative intestinal dysfunction in patients with gastrointestinal cancers: meta-analysis.

BACKGROUND: The Japan Society for Oriental Medicine makes a compilation of structured abstracts of randomized controlled trials (RCTs) of Kampo medicines available on its Evidence Reports of Kampo Treatment (EKAT) website. METHODS: Using EKAT, we conducted a systematic review and meta-analysis on the efficacy of using daikenchuto ( https://mpdb.nibiohn.go.jp/stork ) for bowel dysfunction after surgery for gastrointestinal cancer. The primary outcomes were the time to first postoperative flatus and the time to first postoperative bowel movement (BM). RESULTS: We found nine relevant RCTs. The mean differences between the daikenchuto group and control group (daikenchuto was not administered) were - 0.43 (95% CI: - 0.77 to - 0.09) days for the time to first postoperative flatus, - 0.29 (95% CI: - 0.59 to 0.01) days for the time to first postoperative BM, and - 0.95 (95% CI: - 1.70 to - 0.21) days for the length of postoperative hospital stay, and the risk ratio of the incidence of intestinal obstruction was 0.60 (95% CI: 0.35-1.03). The time to first postoperative flatus and the length of postoperative hospital stay were significantly shorter in the daikenchuto group than those in the control group (P = 0.01). However, only double-blind studies were evaluated; the results turned to be non-significant. CONCLUSION: As a result of meta-analysis by all retrieved according to the registered protocol, daikenchuto was efficacious in improving postoperative bowel dysfunction in patients with gastrointestinal cancers. However, limiting to articles with description of COI and blindness, significance disappeared.

[The Japanese legal system and the applicability of laws and regulations on private information protection and research ethics relating to medical research].

Objectives　To clarify the structure, applicability, and objectives of the current Japanese legislation for private information protection and research ethics and to examine the clauses of the related laws/regulations for academic research purposes.Methods　The research design is a descriptive study based on a systematic literature review. Using the "e-Gov" database, the laws/regulations relating to private information protection and research ethics that apply to medical research involving human subjects and human genome/gene analysis research were included in the research. The Drugs Law (Law No. 145 of 1960) and related GCP/GPSP regulations and laws/regulations on administrative organizations, management, and procedures were excluded. Furthermore, the guidelines and Q&A relating to these laws/regulations and all 47 prefectural regulations on private information protection have been selected from the websites of the related ministries, government organizations, and prefectures.Results　Our study demonstrated that the current legal system on private information protection consists of three layers and that the applicability of the laws/regulations in this area varies according to the type of research organization. Additionally, the applicability of the laws/regulations on research ethics is different depending on the research area. While the Private Information Protection Law (PIPL) for the private sector contains two objectives, PIPL for administrative organizations and PIPL for independent administrative organizations both include three objectives. For academic research purposes, PIPL for the private sector sets out a holistic exemption clause, whereas the other two PIPLs stipulate three specific exemption clauses. Furthermore, our research revealed that the clauses of the prefectural regulations demonstrated many variances.Conclusion　This study suggests that the current Japanese legal system relating to private information protection could be defined as a "mixed model," wherein the laws/regulations concerned are not necessarily consistent. The protection of medical information is solely regulated by a few specific laws with a narrow scope of application; the ethical guidelines are not directly based on any laws; and identifying applicable laws/regulations, depending on the category of research organization, is complicated, especially in the case of collaborative research involving researchers from various organizations. Therefore, in the larger framework of legislation, it is indispensable to reconsider the protection of private medical information and its effective use, including the ethics of this process because of the sensitive and useful nature of private medical information.

Gestational diabetes mellitus in women born small or preterm: Systematic review and meta-analysis.

PURPOSE: There is some evidence that women born preterm or with low birth weight (LBW) have an increased future risk of gestational diabetes mellitus (GDM) during pregnancy; however, a quantitative summary of evidence is lacking. In this systematic review and meta-analysis, we examined the published data to investigate whether being born preterm, with LBW or small for gestational age (SGA) are associated with GDM risk. METHODS: We searched the MEDLINE, Embase, and CINAHL databases and study registries, including ClinicalTrials.gov and ICTRP, from launch until 29 October 2020. Observational studies examining the association between birth weight or gestational age and GDM were eligible. We pooled the odds ratios and 95% confidence intervals using the DerSimonian and Laird random-effects model. RESULTS: Eighteen studies were included (N = 827,382). The meta-analysis showed that being born preterm, with LBW or SGA was associated with increased risk of GDM (pooled odds ratio = 1.84; 95% confidence interval: 1.54-2.20; I2 = 78.3%; τ2 = 0.07). Given a GDM prevalence of 2.0, 10, and 20%, the absolute risk differences were 1.6%, 7.0%, and 11.5%, respectively. The certainty of the evidence was low due to serious concerns of risk of bias and publication bias. CONCLUSIONS: Women born prematurely, with LBW or SGA status, may be at increased risk for GDM. However, whether this should be considered in clinical decision-making depends on the prevalence of GDM.

Association of low birthweight and premature birth with hypertensive disorders in pregnancy: a systematic review and meta-analysis.

BACKGROUND: Growing evidence suggests that women born preterm or small have an increased risk of experiencing hypertensive disorders during pregnancy; however, a quantitative summary of the evidence on this issue is unavailable. OBJECTIVE: We aimed to systematically review the literature to describe the association between being born preterm, low birthweight (LBW), or small for gestational age (SGA), and future gestational hypertension, preeclampsia, or eclampsia. METHODS: We searched the MEDLINE, Embase, CINAHL, ClinicalTrials.gov, and ICTRP databases. We included all cohort and case-control studies examining the association between LBW, preterm birth, or SGA and hypertensive disorders in pregnancy. We pooled the odds ratios and 95% confidence intervals using the DerSimonian and Laird random-effects model. We assessed the certainty of evidence for each outcome using the Grading of Recommendations, Assessment, Development, and Evaluation criteria. RESULTS: Eleven studies were identified, totalling 752 316 participants. Being born preterm, LBW, or SGA was associated with gestational hypertension [pooled odds ratio (OR), 1.31; 95% confidence interval (CI) 1.15-1.50; moderate certainty of evidence] and preeclampsia (pooled OR, 1.35; 95% CI 1.23-1.48; moderate certainty of evidence). No study measured eclampsia as an outcome. CONCLUSION: Women born preterm, LBW, or SGA have an increased risk of gestational hypertension and preeclampsia. The course of the mother's own birth might be used to identify women at risk of gestational hypertension and preeclampsia.

Evaluation of Clinical Practice Guidelines for Rare Diseases in Japan.

Introduction: The insufficient quantity and quality of clinical epidemiological evidence in the field of rare diseases have posed methodological challenges to develop clinical practice guidelines (CPGs). Guideline development groups struggle to provide patients and their families with beneficial guidance, such as that for medical care and in complex circumstances. Motivated by the challenges, we focused on information on resources for supporting the daily and social life to improve the CPGs for users. We aimed to assess the methodological quality of CPGs for rare diseases in Japan and to evaluate information on resources to support the daily and social life in the CPGs. Methods: We conducted a systematic search using PubMed, three electronic Japanese databases, and two hand-searched sources in Japan. The Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument with six domains was used to assess the methodological quality of the CPGs. A content analysis of the CPG text was conducted using five keywords as information on non-medical resources, e.g., "Intractable Disease Consultation Support Center," "Japan Intractable Disease Information Center," and "Patient Association." Results: A total of 55 CPGs met the inclusion criteria. Among four domains of AGREE II with low scores (Stakeholder Involvement, Rigor of Development, Applicability, and Editorial Independence), Rigor of Development had the lowest median score. As for information on non-medical resources, 41 CPGs included at least 1 of the 5 keywords, while 14 CPGs included none. Conclusions: At the Rigor of Development domain, methodological challenges may have resulted in an insufficient description of items regarding the translation evidence to recommendations. As the sufficiency of five keywords as information on non-medical resources could be improved, the information will be advocative as clues to provide pragmatic guidance, particularly for rare diseases with limited medical evidence.

Helicobacter pylori Infection Mass Screening for Children and Adolescents: a Systematic Review of Observational Studies.

PURPOSE: Population-based Helicobacter pylori (H. pylori) screening and eradication for adults in areas with a high incidence of gastric cancer have been shown to be effective. The current status of H. pylori screening for young people, however, has not been sufficiently evaluated. METHODS: A systematic review of population-based H. pylori screening of young people was performed using four databases (MEDLINE, EMBASE, the Cochrane Library, and ICHUSHI) and independently evaluated by two investigators. Studies were evaluated with regard to the country, region, screening method, target age, number of screened people, and rate of positive screening. RESULTS: From 3231 studies, 39 studies were included (14 English original studies published in peer-review journals, 6 Japanese original studies, and 19 conference reports). These studies originated from 10 countries, with the largest number stemming from Japan (29 studies) followed by Germany (2 studies). Screening was performed using the urea breath test, blood antibodies, stool antigens, and urine antibodies. Five countries used the breath test as the first screening method, five used blood samples, two used stool antigens, and only Japan used urinary tests. CONCLUSION: Screening for H. pylori in young people was reviewed based on reports from several countries, and findings suggest that local authorities considering screening for H. pylori in young people need to scrutinize the age and potential methods. Further research is required to determine the effectiveness of mid- to long-term H. pylori screening for young people.

Severity and prevalence of burnout syndrome in paediatric intensive care nurses: A systematic review.

OBJECTIVES: The aim of this study is to identify burnout syndrome severity and prevalence in paediatric intensive care unit nurses. DESIGN: Systematic review. SETTING: Paediatric intensive care unit. MAIN OUTCOME MEASURES: A librarian was consulted on methodology before the search process. MEDLINE (via PubMed), EMBASE, the Cochrane Library, CINAHL, and PsycINFO were searched for full-text studies published before September 2019 in any language. Only those observational studies exploring burnout syndrome, including paediatric intensive care unit nurses, were included. Two authors independently screened studies. We assessed the risk of bias within each study based on the Office of Health Assessment and Translation tool. RESULT: After screening 1238 articles, we identified six studies which met the systematic review criteria. All studies included were published after 2012 and participant sample sizes were between 35 and 195 nurses. Three studies were conducted in the United States of America while the others were from the United Kingdom, Turkey and Taiwan. Prevalence of burnout syndrome in pediatric intensive care unit nurses was reported in these studies as between 42% and 77%. The assessment tools used in these studies were the (abbreviated) Maslach Burnout Inventory, Abbreviated Maslach Burnout Inventory, Occupational Burnout Inventory, and Professional Quality of Life Scale Version 5. We could not conduct a meta-analysis due to the lack of studies. CONCLUSION: Our systematic review identifies that a low number (6 total) of relevant studies focused on burnout syndrome for pediatric intensive care unit nurses with a prevalence of burnout syndrome in paediatric intensive care unit nurses of between 42% and 77%.

Maternal and neonatal outcomes in birth centers versus hospitals among women with low-risk pregnancies in Japan: A retrospective cohort study.

AIM: In order for low-risk pregnant women to base birth decisions on the risks and benefits, they need evidence of birth outcomes from birth centers. The purpose of this study was to describe and compare the maternal and neonatal outcomes of low-risk women who gave birth in birth centers and hospitals in Japan. METHODS: The participants were 9588 women who had a singleton vaginal birth at 19 birth centers and two hospitals in Tokyo. The data were collected from their medical records, including their age, parity, mode of delivery, maternal position at delivery, duration of labor, intrapartum blood loss, perineal trauma, gestational weeks at birth, birth weight, Apgar score, and stillbirths. For the comparison of birth centers with hospitals, adjusted odds ratios for the birth outcomes were estimated by using a logistic regression analysis. RESULTS: The number of women who had a total blood loss of >1 L was higher in the midwife-led birth centers than in the hospitals but the incidence of perineal lacerations was lower. There were fewer infants who were born at the midwife-led birth centers with Apgar scores of <7, compared to the hospitals. CONCLUSION: This study was the first to compare important maternal and neonatal outcomes of birth centers and hospitals. Additional research, using matched baseline characteristics, could clarify the comparisons for maternal and neonatal outcomes.

Prophylactic management of postpartum haemorrhage in the third stage of labour: an overview of systematic reviews.

BACKGROUND: Postpartum haemorrhage is a direct cause of maternal death worldwide and usually occurs during the third stage of labour. Most women receive some type of prophylactic management, which may include pharmacological or non-pharmacological interventions. The objective of this study was to summarize systematic reviews that assessed the effects of postpartum haemorrhage prophylactic management during the third stage of labour. METHODS: We applied the guidelines for conducting an overview of reviews from the Cochrane Handbook for Systematic Reviews of Interventions. We searched MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews to identify all relevant systematic reviews of randomized controlled trials of prophylactic management of postpartum haemorrhage in the third stage of labour compared with no treatment, placebo, or another management technique. Two review authors independently extracted data and assessed methodological quality using a measurement tool to assess reviews and quality of evidence using the Grades of Recommendation, Assessment, Development, and Evaluation for primary outcomes, summarizing results narratively. RESULTS: We identified 29 systematic reviews: 18 Cochrane and 11 non-Cochrane. Cochrane systematic reviews were high quality, while the quality of non-Cochrane systematic reviews varied. The following techniques suggested effective, third-stage interventions to reduce the incidence of severe postpartum haemorrhage: active management of the third stage of labour compared to physiological management, active management compared to expectant management, administration of oxytocin compared to placebo, and use of tranexamic acid compared to placebo. The following third-stage management approaches reduced the need for blood transfusion: active management compared to physiological management, active management compared to expectant management, oral misoprostol compared to placebo, and tranexamic acid compared to placebo. CONCLUSIONS: No effective prophylactic management techniques were identified for maternal mortality. Most methods of effective prophylactic management of postpartum haemorrhage were supported by evidence; however, they were limited to low- or moderate-quality evidence, and high-quality studies are therefore needed. Outcome measures of the included systematic reviews varied. It is recommended that outcome measures in preventive postpartum haemorrhage intervention trials align with the World Health Organization guidelines. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42016049220 .

Uterine activity during the two hours after placental delivery among low-risk pregnancies: an observational study.

OBJECTIVE: The purpose of this study was to describe uterine activity within the first two hours after placental delivery among low-risk pregnant women. MATERIALS AND METHODS: Participants were 17 low-risk pregnant women who had a singleton birth at midwifery birth centers in Japan. Contractile waves of uterine activity were measured by using an external tocodynamometer. RESULTS: Spontaneous uterine contraction frequency during the first two hours after the placental delivery decreased over time (F9, 54 = 19.7, p < 0.001). The mean contraction intervals were 1.9 ± 0.3 min, 2.4 ± 0.9 min, 4.2 ± 0.7 min and 7.9 ± 2.1 min for the second stage, third stage, and the first hour and second hour after placental delivery, respectively. Uterine contraction frequency increased with oxytocin administration and infant suckling; however, an icepack to cool the uterus did not change the contraction waves. No correlations were found between uterine activity and blood loss or pain. CONCLUSION: Contraction of the myometrium is the primary mechanism for hemostasis. The uterine contraction intervals became prolonged over time, and blood loss did not increase. The findings provide insight into the role of myometrium contraction as a hemostasis mechanism.

Cooling the lower abdomen to reduce postpartum blood loss: A randomized controlled trial.

BACKGROUND: Cooling the lower abdomen is one of the Japanese traditional non-pharmacological prophylactic managements for postpartum hemorrhage. This study aimed to evaluate the effectiveness of cooling the lower abdomen in reducing postpartum blood loss compared with no intervention. In both cases, women delivered vaginally without prophylactic oxytocin in the third stage of labor. METHODS: In this randomized controlled trial, the lower abdomen was cooled by placement of an 8.6°C icepack during the first 2 h after placental delivery. The primary outcome was measured as the total blood loss within 2 h after delivery. This study had 80% power at the two tails of 5% significance level to detect the mean difference (MD, 70 g) in total blood loss within 2 h after delivery between the two groups. The sample size was calculated as 144 women (72 women per group). RESULTS: Between January and May 2016, 160 women were randomly assigned to the intervention group (cooling the lower abdomen, n = 81) or the control group (n = 79). Baseline characteristics were similar between groups, with the exception of mean blood loss during the third stage of labor. The primary outcome was not reduced by cooling, compared with no intervention (mean blood loss, 513.3 vs. 478.1 g, respectively; MD = 35.2 g; 95% confidence interval = -65.3-135.7). No adverse events occurred; however, seven (8.7%) women in the intervention group declined to continue cooling the lower abdomen because of discomfort. CONCLUSION: Compared with the control group, cooling the lower abdomen did not reduce the total amount of blood loss up to 2 h after delivery. TRIAL REGISTRATION: UMIN-CTR UMIN000019834.

Elevated D-dimer level is a risk factor for coronary artery lesions accompanying intravenous immunoglobulin-unresponsive Kawasaki disease.

Although there are many reports on the resistance of Kawasaki disease (KD) to initial intravenous immunoglobulin (IVIg) therapy, risk factors for coronary artery lesions in such cases remain to be established. The objective of this study was to explore when additional therapies should be administered and to identify factors helpful for selecting a therapeutic option. Based on their written clinical records, we performed a retrospective review of KD patients who did not respond to initial IVIg therapy and who therefore then underwent plasma exchange (PE) therapy. This was a case-control study to compare the presence or absence of acute coronary lesions in patients treated by PE for IVIg-unresponsive KD at Yokohama City University Hospital or at Yokohama City University Medical Center. Fifteen of 44 patients had acute coronary artery lesions (CAL) correlating with high levels of white blood cells (WBC) (P = 0.045), D-dimer (P = 0.008), and fibrin/fibrinogen degradation products (P = 0.009) and lower levels of fibrinogen (P = 0.013) prior to PE therapy. There was a strong correlation between pre-PE levels of albumin and D-dimer (Pearson's correlation coefficient of 0.610). Multivariate analyses revealed that the odds ratio for CAL when D-dimer was ≥ 4.5 µg/mL was 25.06 (95% CI, 2.56-244.91, P = 0.006). D-dimer elevation and albumin decline in IVIg-unresponsive KD patients could be risk factors for acute CAL, suggesting the possibility that angitis has spread throughout the arterial system, as far as the coronary artery.

Direct interaction of Cucurbitacin E isolated from Alsomitra macrocarpa to actin filament.

A methanol extract of Alsomitra macrocarpa leaves and branches induced a marked alteration of cell morphology in a human stellate cell line (LX-2). Similar morphologic alterations were observed in several other cell lines. Active compound was purified from the extract and determined to be cucurbitacin E (Cuc E). It has been known that Cuc E causes marked disruption of the actin cytoskeleton, supporting our observation, but how Cuc E altered the actin cytoskeleton has not been elucidated. By using the standard fluorescence assay using copolymerization and depolymerization of native and pyrene labelled actin, this study revealed that Cuc E interacted directly with actin consequently stabilizing the polymerized actin. When NIH-3T3 cells exogenously expressing YFP-labeled actin were treated with Cuc E, firstly the aggregation of globular actin and secondly the aggregation of actin including disrupted fibrous actin in the cells was observed.