Early vs. delayed amniotomy in individuals undergoing pre-induction cervical ripening with transcervical Foley balloon: A meta-analysis.

OBJECTIVES: To systematically review randomized controlled trials (RCTs) and perform a meta-analysis comparing early amniotomy with delayed amniotomy in individuals undergoing pre-induction cervical ripening by Foley balloon. The primary outcome was the rate of cesarean delivery. Understanding the impact of the timing of amniotomy on the rate of cesarean delivery is crucial for obstetricians and healthcare providers when making decisions about the management of labor induction. DATA SOURCES: Data were sourced from electronic databases, including PubMed, OVID, Cochrane Library, Web of Science, and ClinicalTrials.gov through February 2024. The review adhered to Preferred Reporting Item for Systematic Reviews guidelines and registered with PROSPERO (ID CRD42023454520). STUDY ELIGIBILITY CRITERIA: Inclusion criteria comprised RCTs comparing early amniotomy with delayed amniotomy in individuals undergoing cervical ripening by Foley balloon. Early amniotomy was defined as amniotomy soon after cervical ripening. Delayed amniotomy was defined as withholding amniotomy until after the onset of the active phase of labor, until at least 4 hours from either initiation of oxytocin or Foley balloon removal/expulsion, or until achieving > 4 cm of dilation. Participants included nulliparous or multiparous individuals with singleton pregnancies undergoing labor induction at 37 weeks or later. STUDY APPRAISAL AND SYNTHESIS: A systematic literature search was conducted using defined search terms including "early amniotomy", "delayed amniotomy", "induction of labor", "cervical ripening", and "Foley balloon", and "Foley catheter." The quality of the included trials was assessed using the Cochrane Risk of Bias Tool for randomized controlled trials. The primary outcome was cesarean delivery. Secondary outcomes included outcomes related to labor duration and neonatal outcomes. Pooled relative risks (RR) and weighted mean differences (WMD) with 95% confidence intervals were calculated. RESULTS: Five trials involving 849 participants undergoing induction and cervical ripening by Foley balloon were included. The rate of cesarean delivery did not differ between individuals randomly assigned to the early amniotomy group compared with those assigned to the delayed amniotomy group (22.9% vs 23.3%; RR 1.00; 95%CI, 0.65-1.55). Early amniotomy compared to delayed amniotomy was associated with a higher proportion of delivery within 24 hours (79.9% vs. 67.1%; RR 1.19; 95%CI 1.04-1.36). Early amniotomy compared with delayed amniotomy was associated with a shorter interval from oxytocin to delivery (WMD -1.5 hours; 95%CI -2.1- -0.8), from Foley expulsion to vaginal delivery (WMD -2.5 hours; 95%CI -4.8- -0.1), and from the start of oxytocin to vaginal delivery (WMD -1.8 hours; 95%CI -3.2- -0.4). Other outcomes were not significantly different. CONCLUSION: Early amniotomy following cervical ripening by Foley balloon in individuals with singleton pregnancies did not impact rates of cesarean delivery compared with delayed amniotomy but led to shorter duration for various labor progress outcomes.

Central and Peripheral Hemodynamics in Young Adults Who Use Water Pipes and the Acute Effects of Water-Pipe Use.

BACKGROUND: Tobacco use via water pipe (commonly referred to as water-pipe smoking [WPS]) is popular among young adults globally and exposes those who smoke to toxicants. RESEARCH QUESTION: Is WPS associated with impaired measures of arterial function and does WPS acutely impair these measures in young adults? STUDY DESIGN AND METHODS: We assessed heart rate (HR), brachial and aortic BP, HR-adjusted augmentation index (AI), and carotid-femoral pulse wave velocity (CFPWV) in 62 individuals who use water pipes and 34 individuals who have never used a water pipe recruited from the community (mean age, 22.5 ± 3.0 years; 48% female). Measurements were obtained before and after an outdoor session of WPS among participants who use water pipes and among the control group of participants who have never used a water pipe. Measurements were compared after vs before exposure and between those who use and those who do not use water pipes, adjusting for possible confounders using linear regression. RESULTS: Participants who use water pipes and control participants had similar demographic characteristics. BP and HR increased acutely after WPS (brachial systolic BP by 4.13 mm Hg [95% CI, 1.91-6.36 mm Hg]; aortic systolic BP by 2.31 mm Hg [95% CI, 0.28-4.33 mm Hg]; brachial diastolic BP by 3.69 mm Hg [95% CI, 1.62-5.77 mm Hg]; aortic diastolic BP by 3.03 mm Hg [95% CI, 0.74-5.33 mm Hg]; and HR by 7.75 beats/min [95% CI, 5.46-10.04 beats/min]), but not in the control group. AI was significantly higher in participants who use water pipes compared with those who do not (9.02% vs 3.06%; P = .03), including after adjusting for BMI and family history of cardiovascular disease (ß = 6.12; 95% CI, 0.55-11.69; P = .03) and when assessing habitual tobacco use via water-pipe extent (water pipes used/day × water-pipe use duration) in water-pipe-years (ß = 2.51/water-pipe-year; 95% CI, 0.10-4.92/water-pipe-year; P = .04). However, CFPWV was similar in those who use water pipes and those who do not, and AI and CFPWV did not change acutely after WPS. INTERPRETATION: In apparently healthy young individuals from the community, habitual WPS was associated with increased AI, a predictor of cardiovascular risk, and one WPS session acutely increased HR and brachial and aortic BP.

A-kinase anchoring protein 13 interacts with the vitamin D receptor to alter vitamin D-dependent gene activation in uterine leiomyoma cells.

OBJECTIVE: To determine if A-kinase anchoring protein 13 (AKAP13) interacts with the vitamin D receptor (VDR) to alter vitamin D-dependent signaling in fibroid cells. Uterine leiomyomas (fibroids) are characterized by a fibrotic extracellular matrix and are associated with vitamin D deficiency. Treatment with vitamin D (1,25-dihydroxyvitamin D3) reduces fibroid growth and extracellular matrix gene expression. A-kinase anchoring protein 13 is overexpressed in fibroids and interacts with nuclear hormone receptors, but it is not known whether AKAP13 may interact with the VDR to affect vitamin D signaling in fibroids. DESIGN: Laboratory studies. SETTING: Translational science laboratory. INTERVENTION(S): Human immortalized fibroid or myometrial cells were treated with 1,25-hydroxyvitamin D3 (1,25(OH)2D3) and transfected using expression constructs for AKAP13 or AKAP13 mutants, RhoQL, C3 transferase, or small interfering ribonucleic acids (RNAs). MAIN OUTCOME MEASURE(S): Messenger ribonucleic acid (mRNA) levels of AKAP13, fibromodulin, and versican as measured by quantitative real-time polymerase chain reaction. Glutathione S-transferase-binding assays. Vitamin D-dependent gene activation as measured by luciferase assays. RESULT(S): 1,25(OH)2D3 resulted in a significant reduction in mRNA levels encoding AKAP13, versican, and fibromodulin. Small interfering RNA silencing of AKAP13 decreased both fibromodulin and versican mRNA levels. Glutathione S-transferase-binding assays revealed that AKAP13 bound to the VDR through its nuclear receptor interacting region. Cotransfection of AKAP13 and VDR significantly reduced vitamin D-dependent gene activation. RhoA pathway inhibition partially relieved repression of vitamin D-dependent gene activation by AKAP13. CONCLUSION(S): These data suggest that AKAP13 inhibited the vitamin D receptor activation by a mechanism that required, at least in part, RhoA activation.

SPECT-CT Imaging of Dog Spontaneous Diffuse Large B-Cell Lymphoma Targeting CD22 for the Implementation of a Relevant Preclinical Model for Human.

Antibodies directed against CD22 have been used in radioimmunotherapy (RIT) clinical trials to treat patients with diffuse large B-cell lymphoma (DLBCL) with promising results. However, relevant preclinical models are needed to facilitate the evaluation and optimization of new protocols. Spontaneous DLBCL in dogs is a tumor model that may help accelerate the development of new methodologies and therapeutic strategies for RIT targeting CD22. Seven murine monoclonal antibodies specific for canine CD22 were produced by the hybridoma method and characterized. The antibodies' affinity and epitopic maps, their internalization capability and usefulness for diagnosis in immunohistochemistry were determined. Biodistribution and PET imaging on a mouse xenogeneic model of dog DLBCL was used to choose the most promising antibody for our purposes. PET-CT results confirmed biodistribution study observations and allowed tumor localization. The selected antibody, 10C6, was successfully used on a dog with spontaneous DLBCL for SPECT-CT imaging in the context of disease staging, validating its efficacy for diagnosis and the feasibility of future RIT assays. This first attempt at phenotypic imaging on dogs paves the way to implementing quantitative imaging methodologies that would be transposable to humans in a theranostic approach. Taking into account the feedback of existing human radioimmunotherapy clinical trials targeting CD22, animal trials are planned to investigate protocol improvements that are difficult to consider in humans due to ethical concerns.

Authorship in reports of clinical practice guidelines: A systematic cross-sectional analysis.

BACKGROUND: A transparent and explicit reporting on authors' contributions to the development of clinical practice guidelines and on panelists' characteristics is essential for their credibility and trustworthiness. We did not find published studies on authorship or panel involvement in clinical practice guidelines. OBJECTIVE: To describe the approach to authorship in reports of clinical practice guidelines, and the characteristics of individual authors. METHODS: We conducted a cross-sectional survey of guidelines listed in the National Guideline Clearing House (NGC) in 2016. We abstracted data on the general characteristics of the guidelines, report approach to authorship, and individual authors characteristics. Data abstraction was in duplicate and independent manner using standardised form. Data analyses were both descriptive and regression analyses. RESULTS: Overall, 139 eligible guidelines with published papers were identified. Of these, 48 (35%) included a group authorship statement in the author byline. A third of these guidelines (n = 45; 32%) reported on authors' contributions, while about half of the guidelines (n = 74; 53%) reported who of the authors served as panel members. Around one-fifth of the guidelines (n = 30; 22%) reported group membership (eg, content expert, patient representative) for at least 1 author. Less than one-seventh of the eligible guidelines indicated who selected the panel members (n = 18; 13%), reported the types of panel members (n = 18; 13%) or the selection criteria (n = 12; 9%). Higher journal impact factor was associated with both "reporting of the author contributions" (OR = 1.07) and "the inclusion of a panel membership section in the guideline report" (OR = 1.21). CONCLUSION: Low percentages of clinical practice guidelines report information on important aspects of authorship and characteristics of individual authors. Better reporting of some of these criteria was associated with journal impact factor.

Long-Term Toxicity of 213Bi-Labelled BSA in Mice.

BACKGROUND: Short-term toxicological evaluations of alpha-radioimmunotherapy have been reported in preclinical assays, particularly using bismuth-213 (213Bi). Toxicity is greatly influenced not only by the pharmacokinetics and binding specificity of the vector but also by non-specific irradiation due to the circulating radiopharmaceutical in the blood. To assess this, an acute and chronic toxicity study was carried out in mice injected with 213Bi-labelled Bovine Serum Albumin (213Bi-BSA) as an example of a long-term circulating vector. METHOD: Biodistribution of 213Bi-BSA and 125I-BSA were compared in order to evaluate 213Bi uptake by healthy organs. The doses to organs for injected 213Bi-BSA were calculated. Groups of nude mice were injected with 3.7, 7.4 and 11.1 MBq of 213Bi-BSA and monitored for 385 days. Plasma parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, were measured and blood cell counts (white blood cells, platelets and red blood cells) were performed. Mouse organs were examined histologically at different time points. RESULTS: Haematological toxicity was transient and non-limiting for all evaluated injected activities. At the highest injected activity (11.1 MBq), mice died from liver and kidney failure (median survival of 189 days). This liver toxicity was identified by an increase in both ALT and AST and by histological examination. Mice injected with 7.4 MBq of 213Bi-BSA (median survival of 324 days) had an increase in plasma BUN and creatinine due to impaired kidney function, confirmed by histological examination. Injection of 3.7 MBq of 213Bi-BSA was safe, with no plasma enzyme modifications or histological abnormalities. CONCLUSION: Haematological toxicity was not limiting in this study. Liver failure was observed at the highest injected activity (11.1 MBq), consistent with liver damage observed in human clinical trials. Intermediate injected activity (7.4 MBq) should be used with caution because of the risk of long-term toxicity to kidneys.