Digital postpartum hemorrhage management device (DPHMD).

BACKGROUND: Primary postpartum hemorrhage (PPH) is an obstetric emergency caused by excessive blood loss that occurs most commonly after the placenta is delivered. PPH can lead to volume depletion, hypovolemic shock, anemia, and it is the leading cause of maternal mortality worldwide. With 470 deaths per 100,000 live births, the maternal mortality ratio in Ethiopia is one of the highest in the world. It is estimated that 94% of births occur at home in Ethiopia and that 10% of maternal deaths are attributed to PPH. Currently, physicians use visual estimation to calculate blood loss and provide fluid during delivery. This traditional method is subjective and generally inaccurate. METHOD: In this project, after delivery blood loss measurement system integrated with fluid delivery and vital sign monitoring method is proposed. The collection and measurement system collects blood loss after delivery and measures the amount of blood loss. The management system continuously monitors the mother's heart rate and blood pressure. These vital sign values are integrated with the measured blood loss to estimate the amount of IV fluid required to be delivered for the mother. The rate of IV fluid delivery is regulated by a flow rate sensor and solenoid valve. RESULTS: The prototype was built and undergone through different tests and iterations. The proposed device was tested for accuracy, cost effectiveness and ease to use. 91.28% accuracy has been achieved and the prototype was built with less than 210 USD. CONCLUSION: The proposed design allows physicians, especially those in low resource setting, to estimate blood loss and deliver fluid accurately. This helps to reduce maternal mortality rate that may occur due to postpartum hemorrhage.

A multiple-perspective approach for the assessment and learning of ultrasound skills.

Ultrasound has become a core skill in many specialties. We evaluated the learning and assessment of ultrasound skills in Obstetrics-Gynaecology in a series of eight studies. In the clinical setting, we found that trainees as well as experienced clinicians struggle with technical aspects of performance such as image optimization. We examined how to improve these aspects of performance in the simulated setting by determining mastery learning levels and exploring learning curves for novices. We then examined how to improve the efficiency of training as well as transfer of learning through the use of dyad practice as compared with single practice. We found that the use of simulation-based training focusing on technical aspects of performance in addition to clinical training led to sustained improvements in performance after two months of clinical training in all aspects of performance. In addition, we found an interaction effect between initial simulation-based training and subsequent clinical training on trainees' need for supervision. These findings suggest that simulation-based training can work as preparation for future learning rather than merely as added learning. Finally, we found that the use of simulation-based initial training led to a large decrease in patients' discomfort, improvements in their perceived safety and confidence in their ultrasound operator. However, simulation-based training comes at a cost and in the final study we developed a model for conducting cost-effectiveness studies and provided data from an example study on how to link training costs with quality of care.

Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial.

BACKGROUND: The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined. METHODS: The fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4-10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection. RESULTS: The package was implemented with high fidelity (85% of HCP trained, n = 204). The questionnaires indicated a good understanding of device use with 75% of participants scoring > 75% (n = 97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation. CONCLUSIONS: This feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial. TRIAL REGISTRATION: ISRCTN41244132 ; Registered 24/11/2015.

The Use and Perceived Barriers of the Partograph at Public Health Institutions in East Gojjam Zone, Northwest Ethiopia.

INTRODUCTION: The partograph is a vital tool used to reduce maternal and fetal mortality and morbidity and to prevent prolonged and obstructed labor, as well as postpartum hemorrhage and fistula formation. This study explored the use and barriers of the partograph among obstetric caregivers in East Gojam Zone, Northwest Ethiopia. METHODS AND MATERIALS: A cross-sectional study design consisting of both quantitative and qualitative methods was utilized. Data was collected through a structured clinical observation checklist and semistructured questions. The content of the checklists was developed according to modified WHO partograph. Thematic analysis was employed using open code software version 3.6. Coding was done immediately after the data was collected. The coded data was defined and categorized into groups. Once the categories were identified and the names given, the data was related to the objectives of the study. Data was crosschecked to ensure consistency between the themes and the categories. Then we summarized the themes and drew conclusions that gave answers to the research questions. RESULTS AND CONCLUSION: This study showed that participants believed partograph is an essential tool used to reduce maternal and fetal mortality and morbidity and to prevent prolonged and obstructed labor, as well as postpartum hemorrhage. They explained that work overload, lack of skill and competency, negligence, lack of motivation and a shortage of infrastructure and resources hindered utilization of the partograph.

Raman spectral signatures of cervical exfoliated cells from liquid-based cytology samples.

It is widely accepted that cervical screening has significantly reduced the incidence of cervical cancer worldwide. The primary screening test for cervical cancer is the Papanicolaou (Pap) test, which has extremely variable specificity and sensitivity. There is an unmet clinical need for methods to aid clinicians in the early detection of cervical precancer. Raman spectroscopy is a label-free objective method that can provide a biochemical fingerprint of a given sample. Compared with studies on infrared spectroscopy, relatively few Raman spectroscopy studies have been carried out to date on cervical cytology. The aim of this study was to define the Raman spectral signatures of cervical exfoliated cells present in liquid-based cytology Pap test specimens and to compare the signature of high-grade dysplastic cells to each of the normal cell types. Raman spectra were recorded from single exfoliated cells and subjected to multivariate statistical analysis. The study demonstrated that Raman spectroscopy can identify biochemical signatures associated with the most common cell types seen in liquid-based cytology samples; superficial, intermediate, and parabasal cells. In addition, biochemical changes associated with high-grade dysplasia could be identified suggesting that Raman spectroscopy could be used to aid current cervical screening tests.

Cytobrush: A tool for sequential evaluation of gene expression in bovine endometrium.

Aims were to (i) compare specific transcript abundance between endometrial samples collected by transcervical biopsy and cytobrush and (ii) measure the abundance of endometrial transcripts involved in PGF2α synthesis in samples collected by cytobrush. In Experiment 1, endometrial samples were taken transcervically by cytobrush and biopsy 10 days after ovulation. Compared to biopsy samples, abundance of transcripts for MSTN, AKR1C4 and PGR was similar, VIM, FLT1 and PTGES was lower (p < .05) and KRT18 and CD3D was greater in cytobrush samples (p < .05). Thus, there was an enrichment of epithelial and immune cells in the cytobrush samples. In Experiment 2, endometrial samples were collected by cytobrush on days 10, 13, 16 and 19 after ovulation. Abundance of PGR2 mRNA was maximum on day 10 then decreased (p < .05). Abundance of ESR1 decreased gradually from day 10 to day 16 then increased again on day 19. The greatest abundance of OXTR was noted on day 19. The sequential alterations in abundance of these transcripts are consistent with the release of PGF2α associated with luteolysis. In summary, cytobrush sampling provides representative, physiologically relevant samples of the luminal epithelium in cattle.

Endometrial sampling devices for early diagnosis of endometrial lesions.

PURPOSE: Endometrial carcinoma is the most common gynecologic malignancy in both developed and some developing countries. Unlike cervical cancer, for which there is routine screening, only patients symptomatic for endometrial carcinoma typically seek medical help for its diagnosis and treatment. Dilatation and curettage (D&C) has been the standard procedure for evaluating suspicious endometrial lesions. The discomfort and injury caused by the D&C procedure, however, restrict its use as a screening method for early diagnosis of endometrial lesions. High-risk endometrial cancer patients would benefit from an effective and low-cost screening test. In recent years, several endometrial devices have been developed and proposed as screening tools. METHODS: We have reviewed and evaluated the literature relating to the endometrial sampling devices in clinical use or clinical trials, with the goal of comparing devices and identifying the most appropriate ones for screening for endometrial lesions. Eligible literature was identified from systematic PubMed searches, and the relevant data were extracted. Comments, letters, unpublished data, conference proceedings, and case reports were excluded from our search. Seventy-four articles on endometrial sampling devices were obtained for this review. RESULTS: The main screening devices for endometrial carcinoma are aspiration devices (such as the Vabra aspirator), Pipelle, Tao Brush, and SAP-1 device. Among these devices, the Tao Brush is the most promising endometrial sampler for screening for endometrial lesions. However, its sampling insufficiency, cost, and unsuccessful insertion rate (20 % in nulliparous and 8 % in parous women) are problematic. CONCLUSIONS: A more accurate and low-cost endometrial sampler, with improved specimen sufficiency and higher sensitivity for endometrial lesions, needs tobe developed and clinically verified.

[HPV contamination of endocavity vaginal ultrasound probes]. / Contamination des sondes d'échographie endovaginale par les papillomavirus humains.

While the use of endovaginal ultrasound probes is increasing, the risk of contamination of women with endocavity vaginal probes was not assessed. In particular, the clinical significance of detection of human papillomavirus (HPV) infection, the most common sexually transmitted viral infection, on endovaginal ultrasound probes is uncertain. The recommendations of good practice for decontamination of these probes developed by the High Council for Public Health and the Academy of Medicine have not been evaluated. The objective of this article was to review recent publications concluding to the detection of HPV and human cellular DNA after gynecological examination and disinfection of vaginal ultrasound probes.

Evaluation of the accuracy in detecting cervical lesions by nurses versus doctors using a stationary colposcope and Gynocular in a low-resource setting.

OBJECTIVES: Evaluation of the performance of VIA (visual inspection with acetic acid) trained nurses to learn colposcopy and the Swede score method to detect cervical lesions by using stationary colposcope or a portable, hand-held colposcope; the Gynocular, as compared to doctors. DESIGN: A crossover randomised clinical trial. SETTING: The Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. PARTICIPANTS: 932 women attending the clinic as either screening naïve for VIA screening (404) or women referred as VIA positive (528) from other VIA screening centres in the Dhaka region. INTERVENTION: VIA trained nurses were trained on-site in colposcopy and in the Swede score systematic colposcopy method. The Swede score grade cervical acetowhiteness, margins plus surface. vessel pattern, lesion size and iodine staining. The women were randomised to start the examination by either a stationary colposcope or the Gynocular. Swede scores were first obtained by a nurse and the same patient was equally evaluated by a doctor. PRIMARY AND SECONDARY OUTCOME MEASURES: Agreement between nurses and doctors in Swede scores was evaluated using the weighted κ statistic for the Gynocular and standard colposcope. The ability to predict CIN 2+ (CIN 2, CIN 3 and invasive cervical cancer) using Swede scores was evaluated using receiver-operating characteristic curves. RESULTS: The Swede scores obtained by nurses and doctors using the Gynocular and stationary colposcope showed high agreement with a κ statistic of 0.858 and 0.859, respectively, and no difference in detecting cervical lesions in biopsy. Biopsy detected CIN 2+ in 39 (4.2%) women. CONCLUSIONS: Our study showed that VIA nurses can perform colposcopy. There was no significant differences compared to doctors in detecting cervical lesions by stationary colposcope or the Gynocular using the Swede score system. Swede scores obtained by nurses using the Gynocular could offer an accurate cervical diagnostic approach in low resource settings. TRIAL REGISTRATION NUMBER: ISRCTN53264564.

Overview of the methods available for biomechanical testing of the uterine cervix in vivo.

OBJECTIVE: To give an overview of the methods available for biomechanical testing of the non-pregnant and pregnant uterine cervix in vivo. METHODS: The following databases were searched. PubMed, Embase, and Cochrane Library. Additional studies were identified from reference lists. Only studies on in vivo biomechanical testing on both pregnant and non-pregnant women were included. MAIN OUTCOME MEASURES: Estimation of distensibility, compressibility, and biochemical composition of the uterine cervix. RESULTS: The distensibility methods evaluated a physiologic variable and might serve as a gold standard; however, they may never be clinically useful as they involve instrumentation of the cervical canal. The compression methods evaluated an unphysiological variable but despite that, they seemed to evaluate biologically relevant figures and were non-invasive. Of the methods evaluating the biomechanical properties indirectly, those based on ultrasound may be clinically useful. Other indirect methods only measured variables within the most superficial layer of the distal uterine cervix, so further studies are needed to evaluate whether these measurements reflect the entire organ. Both compression methods and indirect methods were similar or superior to the Bishop score and to cervical length measurements regarding prediction of spontaneous preterm delivery and successful induction of labor in small studies. CONCLUSION: The methods may have the potential to detect the biomechanical changes in the uterine cervix before the cervical length has shortened. The most promising methods need large-scale clinical testing regarding induction of labor and preterm delivery before they can be used in the clinic.

Cateterização vesical em mulheres / Urinary tubes management in women

Os procedimentos em Ginecologia e Obstetrícia estão vinculados à utilização de diversos equipamentos, para auxiliar na introdução de nutrientes, medicamentos e outros componentes terapêuticos, ou para remover fluidos, em decorrência de alguma afecção. Dentre esses dispositivos, os tubos ou cateteres, principalmente os vesicais, destacam-se por seu uso frequente em mulheres. Este artigo descreve os aspectos mais importantes desses cateteres, enfatizando sua indicação, cuidados técnicos e adversidades advindas de sua utilização incorreta.(AU)

The Gynecologic and Obstertrics procedures are frequently associated to the necessity of using equipments to promote the introduction of nutrients, drugs and other therapeutic compounds, or to remove fluids produced by different disturbances. The urinary catheters are the devices most frequently used in the woman health care. This paper describes important aspects of the urinary tubes usage, emphasising their indication, technique caution and complications due to their wrong employment.(AU)

Comparación de una prueba rápida y una prueba de amplificación mediada por transcripción para el diagnóstico de infección por Chlamydia trachomatis utilizando hisopados endocervicales / Comparison of a rapid test and a test of mediated amplification by transcription for diagnosis of Chlamydia trachomatis using endocervical swabs

La infección por Chlamydia trachomatis es la infección de transmisión sexual bacteriana más frecuente en todo el mundo, La Organización Mundial de la Salud estima que 90 millones de casos ocurren a nivel mundial. El objetivo de este estudio fue evaluar el desempeño de la prueba rápida HEXAGON CHLAMYDIA para el diagnóstico de infección por Chlamydia trachomatis en muestras de secreción endocervical de mujeres usuarias que asisten al consultorio de planificación familiar del "Hospital Nacional Dos de Mayo" y trabajadoras sexuales del servicio PROCETTS del Centro de Salud "Alberto Barton". Se estudiaron un total de 101 muestras de secreción endocervical, 50 muestras de mujeres que asistieron al consultorio de planificación familiar del "Hospital Nacional Dos de Mayo" y 51 muestras de trabajadoras sexuales del servicio PROCETTS del Centro de Salud "Alberto Barton". A todas las mujeres se les tomó dos muestras de secreción endocervical, una de las muestras fue procesada por la prueba rápida inmunocromatográfica HEXAGON CHLAMYDIA en evaluación y la otra por una prueba validada de amplificación de los ácidos nucleicos (nucleic acid amplification, NAATs, por sus siglas en inglés): APTIMA COMBO 2 basada en la metodología de amplificación mediada por transcripción (transcription mediated amplification, TMA, por sus siglas en inglés) Se detectaron 4 casos de infección por C. trachomatis, todos estos casos se encontraron en el grupo de usuarias del consultorio de planificación familiar mientras en el grupo de trabajadoras sexuales no se encontró ninguno. La sensibilidad y la especificidad de la prueba rápida HEXAGON CHLAMYDIA fue 75 por ciento y 84,5 por ciento. El valor predictivo positivo fue 16,7 por ciento y el valor predictivo negativo fue 98,7 por ciento. El valor Kappa fue 0,21. La prueba rápida HEXAGON CHLAMYDIA en este estudio tuvo un pobre desempeño al ser comparada con la prueba APTIMA COMBO 2.

Infection with Chlamydia trachomatis is the most common bacterial sexually transmitted worldwide. The World Health Organization estimates that 90 million cases occur worldwide. The objective in this study was to evaluate the performance of point of care HEXAGON CHLAMYDIA for the diagnosis of Chlamydia trachomatis infection in endocervical secretion samples from women who attended in the family planning service of "Hospital Nacional Dos de Mayo" and female sex workers who attend in the PROCETSS service of "Alberto Barton" Health Center. A total of 101 endocervical secretion samples were collected, 50 sample from women who attended family planning service of "Dos de Mayo" Hospital and 51 samples from female sex workers that were attended in PROCETTS service of "Alberto Barton" Health Center. AII women were taking two samples of endocervical secretion; one swab was tested with point of care Hexagon Chlamydia and the other swab was validated test nucleic acid amplification (NAAT): APTIMA COMBO 2 based on transcription mediated amplification reaction (TMA). Four cases of C. trachomatis were detected; all these cases were found in women who attended in the family planning service while in the group of female sex workers no cases were detected. The sensitivity and specificity of the point of care HEXAGON CHLAMYDIA were 75 per cent and 84.5 per cent respectively. The positive predictive value was 16.7 per cent and negative predictive value was 98.7 per cent. The Kappa value was 0.21. The point of care HEXAGON CHLAMYDIA had a poorly performance when was compared to the APTIMA COMBO 2 (TMA).

Semiología gineco - obstétrica por competencias / Semiology gynecology - obstetric by competences

El libro semiología gine-obstétrica por competencias, está dirigido a docentes y alumnos de la carrera de ginecología y obstetricia del pregrado de la carrera de medicina, que anhelen mejorar sus conocimientos y destrezas, con la intención de alcanzar las competencias necesarias para la atención de pacientes gineco-obstétricas. Los contenidos ase han organizado en sesiones siguiendo una secuencia para facilitar el aprendizaje. 1- Donde examino?: región anatómica 2 Que examino?: el o los órganos ubicados en dicha región y que serán objeto de examen 3- Cómo examino?: los pasos a seguir para lograr realizar el examen físico en forma correcta 4- Cuáles son los posibles hallazgos fisiológicos o patológicos?: en este punto el alumno pone en práctica sus conocimientos teóricos para llegar al diagnóstico presuntivo de modo a adoptar la conducta adecuada la caso. Al finalizar casa sesión, se encuentras las guías de aprendizaje y las listas de verificación. Las guías de aprendizaje contienen los pasos que se deben seguir para realizar un determinado procedimiento. Las listas de verificación sirven para medir el progreso del aprendizaje y sirven como mecanismo de auto evaluación para el estudiante y evaluación del alumno por parte del profesor. Finalmente, el libro de texto, Semiología gineco-obstétrica por competencias, busca integrar el saber con el saber hacer sin descuidar el saber ya que da pautas para el manejo de pacientes no solo con calidad técnica sino también con calidad humana al establecer normas para una correcta relación médico-paciente.

Cytological diagnosis of endometritis in the mare: investigations of sampling techniques and relation to bacteriological results.

Aim of this study was to compare uterine smears made using the Knudsen catheter, the cytology brush and a uterine culture swab with regard to diagnostic usefulness and the occurrence of neutrophils. Additionally correlation between culture results and the occurrence of neutrophils in uterine smears was investigated. Samples were collected from 340 mares, 81.5% of which were in estrus. Smears made using the cytology brush yielded more endometrial cells per high-power field than those made using the other two instruments (p<0.0001), and a larger proportion had PMNs compared with smears made using the uterine swab (p<0.0001). For smears made with the cytology brush, cultures of ß-hemolytic streptococci were more often (p=0.002) accompanied by PMNs than cultures of bacteria other than ß-hemolytic streptococci, and there was a positive correlation (r(s)=0.2 p=0.01) between the number of PMNs in smears and the number of colonies of ß-hemolytic streptococci. The cytology brush was superior to the other methods because it generated a larger proportion of diagnostic useful smears and the occurrence of PMNs in smears was significantly correlated with the occurrence of cultures of ß-hemolytic streptococci.

Comparison of the cytobrush, cottonswab, and low-volume uterine flush techniques to evaluate endometrial cytology for diagnosing endometritis in chronically infertile mares.

Endometritis is the most important cause of infertility in barren mares. The quick method of endometrial cytology (EC) has a relatively high reliability in diagnosing endometrial inflammation in the mare. For reliable cytological results, a collection technique that yields many well-preserved cells representative of a large uterine surface area without causing harm to the reproductive tract is required. The aim of the study was to compare three usually employed techniques for collection of endometrial and inflammatory cells (guarded cotton swab, uterine lavage, and cytobrush) in chronically infertile mares. Twenty Standardbred mares were used. In each mare, samples for EC were collected, first by a cotton swab (DGS), then by a cytobrush (CB), and finally by low volume flush (LVF). The slides were stained using the Diff Quick stain. The following parameters were assessed for each tested technique: background content of the slides; quality of the cells harvested; total cellularity; neutrophils; ratio PMN/uterine epithelial cells; inflammatory cells; vaginal epithelium cells. Categorical variables were compared using contingency tables and Pearson Chi-square tests, whereas continuous variables were compared using one-way analysis of variance (ANOVA); P<0.05 was considered significant. Samplings by DGS and CB resulted easy and quick to perform via a single operator in all cases. LVF was performed easily, but required the presence of 2-3 players and took more time. The background content of the slides prepared by DGS appeared proteinaceous, slides prepared by LVF appeared contaminated by red blood cells or debris, whereas slides prepared by CB appeared clear. All smears showed a good total cellularity. The CB yielded significantly more cells (P<0.0001) than DGS and LVF. The DGS produced significant more cells than LVF (P<0.0001). The DGS produced significantly more (P=0.003) intact cells than CB and LVF. Distorted cells were significantly (P=0.001) more frequent in smears by LVF. The CB harvested significantly (P=0.009) more fragmented cells. CB and LVF produced significantly (P<0.0001; P=0.02) more PMNs/HPF than DGS. In smears collected by LVF the proportion of PMNs/uterine epithelial cells was significantly (P=0.0062; P=0.0023) higher than in smears by CB and DGS. CB collected a significantly higher (P=0.0011) proportion of PMNs than DGS. Acute endometritis was diagnosed in 50% (10/20) of the mares by DGS cytological samples, 25% (5/20) by CB, and 75% (15/20) by LVF. Inflammatory cells other than PMN (lymphocytes, macrophages, eosinophils) were collected exclusively by CB method. Epithelial cells from the vagina were only detected in LVF slides. The agreement of the diagnosis of endometritis between the three techniques of collection and between the different criteria adopted to evaluate smears obtained with the same technique was poor (k≤0.3). In conclusion, results show that cytobrush and flush specimens were superior in all parameters to cotton swab smears. Even though the cytobrush technique requires specialized equipment, sample collection by this method was easier, more consistent, and quicker than the lavage method, indicating that the brush would be the preferred collection method for use on field in the mare. More studies are needed to establish criteria for interpretation of inflammation in the mare on cytobrush samples.

Medical devices; immunology and microbiology devices; classification of ovarian adnexal mass assessment score test system. Final rule.

The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System." The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices

PP13 as a marker of pre-eclampsia: A two platform comparison study.

OBJECTIVE: To evaluate the role of PP13 as a marker for pre-eclampsia (PE) by comparing two different immunoassay platforms. METHODS: In this case-control study, first-trimester serum samples from 195 normal pregnancies and 37 pregnancies with PE were analysed for PP13 by using a manual DTL ELISA and the AutoDELFIA(®) platform. RESULTS: Levels of PP13 in first-trimester pregnancies increased with gestational age in controls and pre-eclampsia cases using both methods of analysis, but at different rates. PP13 levels were decreased in women with PE. Levels of the marker are found to be more reduced in PE cases when measured using the DTL ELISA compared to AutoDELFIA(®). CONCLUSION: Further studies are needed to compare the performance of the DTL ELISA and the AutoDELFIA(®) PP13 assays in terms of reproducibility, robustness and clinical performance in predicting pre-eclampsia.

Avaliação da qualidade de imagens de equipamentos de ultrassom modo B / Image quality evaluation of B-mode ultrasound equipment

Este trabalho teve por objetivo o desenvolvimento e avaliação da eficácia de um protocolo de controle de qualidade de imagens geradas por equipamentos de ultrassom operando no modo B, que fosse de fácil implementação e que utilizasse um único objeto de testes. O protocolo proposto foi avaliado em 25 equipamentos de ultrassom utilizados em medicina obstétrica, ginecologia e clínica médica, selecionados em várias clínicas e hospitais de Curitiba, Brasil. Somente modelos de equipamentos que suportavam os três tipos padrões de transdutores (convexo, linear e endocavitário) foram incluídos nos testes. No entanto, em alguns dos equipamentos, nem todos os transdutores estavam disponíveis, totalizando 72 transdutores avaliados durante os testes. Um objeto de testes de uso geral foi utilizado para avaliar os seguintes parâmetros: resoluções laterais e axiais, profundidade de visualização e exatidão das distâncias medidas, entre outras. O protocolo foi implementado em duas partes: uma envolvendo a inspeção física do equipamento/monitor e outra para avaliação dos transdutores. Entre os resultados obtidos, pode-se destacar a efetividade e simplicidade do protocolo proposto, o qual é completamente baseado em um único objeto de testes. Considerando as normas e relatórios técnicos utilizados, para aproximadamente 86% dos transdutores avaliados, falhas foram detectadas em um ou mais indicadores de qualidade de imagem. Os resultados obtidos estão de acordo com outros estudos realizados no Brasil, mostrando que um grande número de equipamentos utilizados diariamente em clínicas e hospitais apresenta um ou mais parâmetros fora dos limites estabelecidos em normas técnicas, tornando difícil o diagnóstico médico e, consequentemente, submetendo o paciente a riscos.

This study aims the development of a quality control protocol of images generated by B-mode ultrasound equipment, being of simple implementation and making use of a single phantom, as well as the evaluation of the proposed protocol effectiveness. The proposed protocol was evaluated on 25 ultrasound equipment used in obstetric medicine, gynaecology and medical clinic, selected from several clinics and hospitals of Curitiba, Brazil. Only systems with three standard transducers (convex, linear and endocavitary types) should be selected, however for some units not all of them were available, thus a total of 72 transducers were tested. A general purpose phantom was used to evaluate the following parameters: lateral and axial resolution, deepness of visualization and accuracy between distances, among others. The protocol was implemented in two parts: one involving the physical inspection of the equipment/monitor and another for the transducers evaluation. Among the results obtained, one is highlighted by the effectiveness and simplicity of the proposed protocol, which is completely based on a single phantom. Considering the utilized standards and technical reports, for approximately 86% of the evaluated transducers, some kind of failure or problem was detected in one or more image quality indicators. The results, inaccordance to those obtained by other authors in Brazil, showed that agreat number of equipment used daily in clinics and hospitals present one or more parameters out of the standards, making the medical diagnosis difficult and consequently submitting the patient to risks.