The OdonAssist™ inflatable device for assisted vaginal birth is an investigational device which underwent premarket clinical testing. The clinical evidence generation plan includes preclinical and ...clinical studies to support development, regulatory approval and post market surveillance of the device.
El dispositivo inflable OdonAssist™ para parto vaginal asistido es un dispositivo de investigación que se sometió a pruebas clínicas previas a la comercialización. El plan de generación de evidencia clínica incluye estudios preclínicos y clínicos para respaldar el desarrollo, la aprobación regulatoria y la vigilancia posterior a la comercialización del dispositivo.
Summary Background Definition of small for gestational age in various populations worldwide remains a challenge. References based on birthweight are deficient for preterm births, those derived from ...ultrasound estimates might not be applicable to all populations, and the individualised reference can be too complex to use in developing countries. Our aim was to create a generic reference for fetal weight and birthweight that overcame these deficiencies and could be readily adapted to local populations. Methods We used the fetal-weight reference developed by Hadlock and colleagues and the notion of proportionality proposed by Gardosi and colleagues and made the weight reference easily adjustable according to the mean birthweight at 40 weeks of gestation for any local population. For application and validation, we used data from 24 countries in Africa, Latin America, and Asia that participated in the 2004–08 WHO Global Survey on Maternal and Perinatal Health (237 025 births). We compared our reference with that of Hadlock and colleagues (non-customised) and with that of Gardosi and colleagues (individualised). For every reference, the odds ratio (OR) of adverse perinatal outcomes (stillbirths, neonatal deaths, referral to higher-level or special care unit, or Apgar score lower than 7 at 5 min) for infants who were small for gestational age versus those who were not was estimated with multilevel logistic regression. Findings OR of adverse outcomes for infants small for gestational age versus those not small for gestational age was 1·59 (95% CI 1·53–1·66) for the non-customised fetal-weight reference compared with 2·87 (2·73–3·01) for our country-specific reference, and 2·84 (2·71–2·99) for the fully individualised reference. Interpretation Our generic reference for fetal-weight and birthweight percentiles can be easily adapted to local populations. It has a better ability to predict adverse perinatal outcomes than has the non-customised fetal-weight reference, and is simpler to use than the individualised reference without loss of predictive ability. Funding None.
Objective The purpose of this study was to describe the unequal distribution in the performance of cesarean section delivery (CS) in the world and the resource-use implications of such inequity. ...Study Design We obtained data on the number of CSs performed in 137 countries in 2008. The consensus is that countries should achieve a 10% rate of CS; therefore, for countries that are below that rate, we calculated the cost to achieve a 10% rate. For countries with a CS rate of >15%, we calculated the savings that could be made by the achievement of a 15% rate. Results Fifty-four countries had CS rates of <10%, whereas 69 countries showed rates of >15%. The cost of the global saving by a reduction of CS rates to 15% was estimated to be $2.32 billion (US dollars); the cost to attain a 10% CS rate was $432 million (US dollars). Conclusion CSs that are potentially medically unjustified appear to command a disproportionate share of global economic resources.
To provide a better understanding of dietary intakes of pregnant women in low- and middle-income countries.
Systematic review was performed to identify relevant studies which reported nutrient ...intakes or food consumption of pregnant women in developing countries. Macronutrient and micronutrient intakes were compared by region and the FAO/WHO Estimated Average Requirements. Food consumption was summarized by region.
Developing countries in Africa, Asia, and the Caribbean and Central/South America.
Pregnant women in the second or third trimester of their pregnancies.
From a total of 1499 retrieved articles, sixty-two relevant studies were analysed. The ranges of mean/median intakes of energy, fat, protein and carbohydrate were relatively higher in women residing in the Caribbean and Central/South America than in Africa and Asia. Percentages of energy from carbohydrate and fat varied inversely across studies in all regions, whereas percentage of energy from protein was relatively stable. Among selected micronutrients, folate and Fe intakes were most frequently below the Estimated Average Requirements, followed by Ca and Zn. Usual dietary patterns were heavily cereal based across regions.
Imbalanced macronutrients, inadequate micronutrient intakes and predominantly plant-based diets were common features of the diet of pregnant women in developing countries. Cohesive public health efforts involving improving access to nutrient-rich local foods, micronutrient supplementation and fortification are needed to improve the nutrition of pregnant women in developing countries.
Inhaling fine particles (particulate matter with diameter ≤ 2.5 μm; PM2.5) can induce oxidative stress and inflammation, and may contribute to onset of preterm labor and other adverse perinatal ...outcomes.
We examined whether outdoor PM2.5 was associated with adverse birth outcomes among 22 countries in the World Health Organization Global Survey on Maternal and Perinatal Health from 2004 through 2008.
Long-term average (2001-2006) estimates of outdoor PM2.5 were assigned to 50-km-radius circular buffers around each health clinic where births occurred. We used generalized estimating equations to determine associations between clinic-level PM2.5 levels and preterm birth and low birth weight at the individual level, adjusting for seasonality and potential confounders at individual, clinic, and country levels. Country-specific associations were also investigated.
Across all countries, adjusting for seasonality, PM2.5 was not associated with preterm birth, but was associated with low birth weight odds ratio (OR) = 1.22; 95% CI: 1.07, 1.39 for fourth quartile of PM2.5 (> 20.2 μg/m3) compared with the first quartile (< 6.3 μg/m3). In China, the country with the largest PM2.5 range, preterm birth and low birth weight both were associated with the highest quartile of PM2.5 only, which suggests a possible threshold effect (OR = 2.54; CI: 1.42, 4.55 and OR = 1.99; CI: 1.06, 3.72 for preterm birth and low birth weight, respectively, for PM2.5 ≥ 36.5 μg/m3 compared with PM2.5 < 12.5 μg/m3).
Outdoor PM2.5 concentrations were associated with low birth weight but not preterm birth. In rapidly developing countries, such as China, the highest levels of air pollution may be of concern for both outcomes.
Celotno besedilo
Dostopno za:
CEKLJ, DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
Normal fetal growth is a critical component of a healthy pregnancy and influences the long-term health of the offspring. However, defining normal and abnormal fetal growth has been a long-standing ...challenge in clinical practice and research. We review various references and standards that are used widely to evaluate fetal growth and discuss common pitfalls of current definitions of abnormal fetal growth. Pros and cons of different approaches to customize fetal growth standards are described. We further discuss recent advances toward an integrated definition for fetal growth restriction . Such a definition may incorporate fetal size with the status of placental health that is measured by maternal and fetal Doppler velocimetry and biomarkers, biophysical findings, and genetics. Although the concept of an integrated definition appears promising, further development and testing are required. An improved definition of abnormal fetal growth should benefit both research and clinical practice.
Virtual worlds are rapidly becoming part of the educational technology landscape. Second Life (SL) is one of the best known of these environments. Although the potential of SL has been noted for ...health professions education, a search of the world's literature and of the World Wide Web revealed a limited number of formal applications of SL for this purpose and minimal evaluation of educational outcomes. Similarly, the use of virtual worlds for continuing health professional development appears to be largely unreported.
We designed and delivered a pilot postgraduate medical education program in the virtual world, Second Life. Our objectives were to: (1) explore the potential of a virtual world for delivering continuing medical education (CME) designed for physicians; (2) determine possible instructional designs using SL for CME; (3) understand the limitations of SL for CME; (4) understand the barriers, solutions, and costs associated with using SL, including required training; and (5) measure participant learning outcomes and feedback. We trained and enrolled 14 primary care physicians in an hour-long, highly interactive event in SL on the topic of type 2 diabetes. Participants completed surveys to measure change in confidence and performance on test cases to assess learning. The post survey also assessed participants' attitudes toward the virtual learning environment.
Of the 14 participant physicians, 12 rated the course experience, 10 completed the pre and post confidence surveys, and 10 completed both the pre and post case studies. On a seven-point Likert scale (1, strongly disagree to 7, strongly agree), participants' mean reported confidence increased from pre to post SL event with respect to: selecting insulin for patients with type 2 diabetes (pre = 4.9 to post = 6.5, P= .002); initiating insulin (pre = 5.0 to post = 6.2, P= .02); and adjusting insulin dosing (pre = 5.2 to post = 6.2, P= .02). On test cases, the percent of participants providing a correct insulin initiation plan increased from 60% (6 of 10) pre to 90% (9 of 10) post (P= .2), and the percent of participants providing correct initiation of mealtime insulin increased from 40% (4 of 10) pre to 80% (8 of 10) post (P= .09). All participants (12 of 12) agreed that this experience in SL was an effective method of medical education, that the virtual world approach to CME was superior to other methods of online CME, that they would enroll in another such event in SL, and that they would recommend that their colleagues participate in an SL CME course. Only 17% (2 of 12) disagreed with the statement that this potential Second Life method of CME is superior to face-to-face CME.
The results of this pilot suggest that virtual worlds offer the potential of a new medical education pedagogy to enhance learning outcomes beyond that provided by more traditional online or face-to-face postgraduate professional development activities. Obvious potential exists for application of these methods at the medical school and residency levels as well.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
To analyse preterm birth rates worldwide to assess the incidence of this public health problem, map the regional distribution of preterm births and gain insight into existing assessment strategies.
...Data on preterm birth rates worldwide were extracted during a previous systematic review of published and unpublished data on maternal mortality and morbidity reported between 1997 and 2002. Those data were supplemented through a complementary search covering the period 2003-2007. Region-specific multiple regression models were used to estimate the preterm birth rates for countries with no data.
We estimated that in 2005, 12.9 million births, or 9.6% of all births worldwide, were preterm. Approximately 11 million (85%) of these preterm births were concentrated in Africa and Asia, while about 0.5 million occurred in each of Europe and North America (excluding Mexico) and 0.9 million in Latin America and the Caribbean. The highest rates of preterm birth were in Africa and North America (11.9% and 10.6% of all births, respectively), and the lowest were in Europe (6.2%).
Preterm birth is an important perinatal health problem across the globe. Developing countries, especially those in Africa and southern Asia, incur the highest burden in terms of absolute numbers, although a high rate is also observed in North America. A better understanding of the causes of preterm birth and improved estimates of the incidence of preterm birth at the country level are needed to improve access to effective obstetric and neonatal care.
Rising cesarean section (CS) rates are a major public health concern and cause worldwide debates. To propose and implement effective measures to reduce or increase CS rates where necessary requires ...an appropriate classification. Despite several existing CS classifications, there has not yet been a systematic review of these. This study aimed to 1) identify the main CS classifications used worldwide, 2) analyze advantages and deficiencies of each system.
Three electronic databases were searched for classifications published 1968-2008. Two reviewers independently assessed classifications using a form created based on items rated as important by international experts. Seven domains (ease, clarity, mutually exclusive categories, totally inclusive classification, prospective identification of categories, reproducibility, implementability) were assessed and graded. Classifications were tested in 12 hypothetical clinical case-scenarios. From a total of 2948 citations, 60 were selected for full-text evaluation and 27 classifications identified. Indications classifications present important limitations and their overall score ranged from 2-9 (maximum grade =14). Degree of urgency classifications also had several drawbacks (overall scores 6-9). Woman-based classifications performed best (scores 5-14). Other types of classifications require data not routinely collected and may not be relevant in all settings (scores 3-8).
This review and critical appraisal of CS classifications is a methodologically sound contribution to establish the basis for the appropriate monitoring and rational use of CS. Results suggest that women-based classifications in general, and Robson's classification, in particular, would be in the best position to fulfill current international and local needs and that efforts to develop an internationally applicable CS classification would be most appropriately placed in building upon this classification. The use of a single CS classification will facilitate auditing, analyzing and comparing CS rates across different settings and help to create and implement effective strategies specifically targeted to optimize CS rates where necessary.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Most maternal deaths, intrapartum-related stillbirths, and newborn deaths in low income countries are preventable but simple, effective methods for improving safety in institutional births have not ...been devised. Checklist-based interventions aid management of complex or neglected tasks and have been shown to reduce harm in healthcare. We hypothesized that implementation of the WHO Safe Childbirth Checklist program, a novel childbirth safety program for institutional births incorporating a 29-item checklist, would increase delivery of essential childbirth practices linked with improved maternal and perinatal health outcomes.
A pilot, pre-post-intervention study was conducted in a sub-district level birth center in Karnataka, India between July and December 2010. We prospectively observed health workers that attended to women and newborns during 499 consecutively enrolled birth events and compared these with observed practices during 795 consecutively enrolled birth events after the introduction of the WHO Safe Childbirth Checklist program. Twenty-nine essential practices that target the major causes of childbirth-related mortality, such as hand hygiene and uterotonic administration, were evaluated. The primary end point was the average rate of successful delivery of essential childbirth practices by health workers. Delivery of essential childbirth-related care practices at each birth event increased from an average of 10 of 29 practices at baseline (95%CI 9.4, 10.1) to an average of 25 of 29 practices afterwards (95%CI 24.6, 25.3; p<0.001). There was significant improvement in the delivery of 28 out of 29 individual practices. No adverse outcomes relating to the intervention occurred. Study limitations are the pre-post design, potential Hawthorne effect, and focus on processes of care versus health outcomes.
Introduction of the WHO Safe Childbirth Checklist program markedly improved delivery of essential safety practices by health workers. Future study will determine if this program can be implemented at scale and improve health outcomes.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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