Design and development of the BD Odon DeviceTM : a human factors evaluation process.

OBJECTIVE: To (1) determine how intended users interact with and use the BD Odon Device in simulation, (2) use these findings to alter progressively the design of the BD Odon Device and (3) validate that these changes have improved the ability of practitioners to use the BD Odon Device. DESIGN: Human factors evaluation study. SETTING: Simulation suite designed to mimic delivery room. POPULATION OR SAMPLE: Three hundred and ninety simulated operative births, performed by 100 practising clinicians. METHODS: Simulated operative vaginal births performed using the BD Odon Device and the device Instructions for use were subjected to three formative human factors evaluations and one human factors validation test. Following each evaluation, findings were reviewed and the design of the BD Odon Device and Instructions for use were modified. MAIN OUTCOME MEASURES: Successful performance of an operative vaginal birth using the BD Odon Device in accordance with provided training and Instructions for use. RESULTS: Using version two of the BD Odon Device, and following exposure to face-to-face training and written instructions, 25% of accouchers were able successfully to perform a simulated operative vaginal birth. In the final evaluation, following device design and training material alterations, all accouchers were able successfully to perform a simulated operative vaginal birth using version four of the BD Odon Device. CONCLUSIONS: Human factors evaluations have enabled a multi-professional device and training materials design team to alter the design of the BD Odon Device and the Instructions for use in an evidence-based fashion. This process has resulted in a device which has a predictable and likely safe pattern of use. TWEETABLE ABSTRACT: Human Factors evaluations help make the BD Odon Device safe and usable for clinical practice.

From design to adoption: generating evidence for new technology designed to address leading global health needs: A comprehensive clinical evidence generation plan for the BD Odon Device™.

Transition from design to adoption of innovations must be evidence-based and inform product development, regulatory approval and adoption.

Effect of maternal zinc supplementation on the cardiometabolic profile of Peruvian children: results from a randomized clinical trial.

Zinc is an essential micronutrient for the development of the fetal renal, cardiovascular and metabolic systems; however, there is limited evidence of its effects on the postnatal cardiometabolic function. In this study, we evaluated the effect of maternal zinc supplementation during pregnancy on the cardiometabolic profile of the offspring in childhood. A total of 242 pregnant women were randomly assigned to receive a daily supplement containing iron+folic acid with or without zinc. A follow-up study was conducted when children of participating mothers were 4.5 years of age to evaluate their cardiometabolic profile, including anthropometric measures of body size and composition, blood pressure, lipid profile and insulin resistance. No difference in measures of child cardiometabolic risk depending on whether mothers received supplemental zinc during pregnancy. Our results do not support the hypothesis that maternal zinc supplementation reduces the risk of offspring cardiometabolic disease.

Are hypertensive disorders in pregnancy associated with congenital malformations in offspring? Evidence from the WHO Multicountry cross sectional survey on maternal and newborn health.

BACKGROUND: Annually, around 7.9 million children are born with birth defects and the contribution of congenital malformations to neonatal mortality is generally high. Congenital malformations in children born to mothers with hypertensive disorders during pregnancy has marginally been explored. METHODS: Country incidence of congenital malformations was estimated using data on the 310 401 livebirths of the WHO Multicountry Survey which reported information from 359 facilities across 29 countries. A random-effect logistic regression model was utilized to explore the associations between six broad categories of congenital malformations and the four maternal hypertensive disorders "Chronic Hypertension", "Preeclampsia" and "Eclampsia" and "Chronic hypertension with superimposed preeclampsia". RESULTS: The occupied territories of Palestine presented the highest rates in all groups of malformation except for the "Lip/Cleft/Palate" category. Newborns of women with chronic maternal hypertension were associated with a 3.7 (95 % CI 1.3-10.7), 3.9 (95 % CI 1.7-9.0) and 4.2 (95 % CI 1.5-11.6) times increase in odds of renal, limb and lip/cleft/palate malformations respectively. Chronic hypertension with superimposed preeclampsia was associated with a 4.3 (95 % CI 1.3-14.4), 8.7 (95 % CI 2.5-30.2), 7.1 (95 % CI 2.1-23.5) and 8.2 (95 % CI 2.0-34.3) times increase in odds of neural tube/central nervous system, renal, limb and Lip/Cleft/Palate malformations. CONCLUSIONS: This study shows that chronic hypertension in the maternal period exposes newborns to a significant risk of developing renal, limb and lip/cleft/palate congenital malformations, and the risk is further exacerbate by superimposing eclampsia. Additional research is needed to identify shared pathways of maternal hypertensive disorders and congenital malformations.

A cluster randomized controlled trial of the non-pneumatic anti-shock garment for obstetric haemorrhage: sub-analysis of the Zimbabwean Arm.

Objectives: To determine whether earlier application of the Non-pneumatic Anti-Shock Garment (NASG) at clinic level compared to the referral hospital level reduces maternal morbidity and mortality and recovery time from shock due to severe Obstetric Haemorrhage (OH) and to determine the safety of the NASG when applied at clinic level. Design: A cluster Randomized Controlled Trial (RCT) Setting: Harare and Parirenyatwa Referral Hospitals (RH) in Harare and the twelve Harare City Council clinics that offer maternity care. Subjects: Women who had suffered severe OH at clinic level and were being transferred to a Referral Hospital (RH). Iterventions: The clinics were randomized into two groups. In the early NASG group eligible women were given the standard management for OH and had the NASG applied at the clinic level before transport to RH. In the control group, eligible women were given the standard management for OH at the clinic level, transferred to the RH, and received the NASG at the RH. All women received equivalent OH/hypovolemic shock management at the RH. Main Outcome Measures: The main outcome measures were maternal mortality and morbidity, blood loss, recovery from shock and the occurrence of side effects whilst in the NASG. Results: There were few maternal deaths and morbidities, and no statistically significant differences between the two groups were noted. Women in the early NASG group spent a statistically significant shorter time in the NASG at referral hospital level (OR 0.64, 95% CI 0.52 - 0.79, p < 0.001) and had a non-significant 40% faster recovery from shock (HR 1.39; 95% CI 0.98-1.97, p=0.07). There were no differences in reported side effects. Conclusion: Earlier NASG application at the clinic level was associated with faster recovery from shock in women who had suffered severe OH and appears safe to use.

What do popular Spanish women's magazines say about caesarean section? A 21-year survey.

OBJECTIVES: Caesarean section (CS) rates are increasing worldwide and maternal request is cited as one of the main reasons for this trend. Women's preferences for route of delivery are influenced by popular media, including magazines. We assessed the information on CS presented in Spanish women's magazines. DESIGN: Systematic review. SETTING: Women's magazines printed from 1989 to 2009 with the largest national distribution. SAMPLE: Articles with any information on CS. METHODS: Articles were selected, read and abstracted in duplicate. Sources of information, scientific accuracy, comprehensiveness and women's testimonials were objectively extracted using a content analysis form designed for this study. MAIN OUTCOME MEASURES: Accuracy, comprehensiveness and sources of information. RESULTS: Most (67%) of the 1223 selected articles presented exclusively personal opinion/birth stories, 12% reported the potential benefits of CS, 26% mentioned the short-term and 10% mentioned the long-term maternal risks, and 6% highlighted the perinatal risks of CS. The most frequent short-term risks were the increased time for maternal recovery (n = 86), frustration/feelings of failure (n = 83) and increased post-surgical pain (n = 71). The most frequently cited long-term risks were uterine rupture (n = 57) and the need for another CS in any subsequent pregnancy (n = 42). Less than 5% of the selected articles reported that CS could increase the risks of infection (n = 53), haemorrhage (n = 31) or placenta praevia/accreta in future pregnancies (n = 6). The sources of information were not reported by 68% of the articles. CONCLUSIONS: The portrayal of CS in Spanish women's magazines is not sufficiently comprehensive and does not provide adequate important information to help the readership to understand the real benefits and risks of this route of delivery.

OS029. Severe anemia, sickle cell disease, and thalassemia as riskfactors for preeclampsia in developing countries.

INTRODUCTION: Hypertensive disorders during pregnancy contribute greatly to maternal and perinatal morbidity and mortality in developing countries. The pathogenesis of such conditions may be illuminated by exploring their relationship to anemia. OBJECTIVES: To determine whether several types of anemia are risk factors for hypertensive disorders during pregnancy in developing countries. METHODS: Using data from the World Health Organization Global Survey for Maternal and Perinatal Health, collected in hospitals in six African and six Latin American countries from 2007 to 2008 and in four Asian countries from 2004 to 2005, we examined the associations between severe anemia, sickle cell disease and thalassemia and gestational hypertension or preeclampsia/eclampsia. After exclusions for comorbidities (chronic hypertension, diabetes, HIV infection) and missing data, the severe anemia, sickle cell disease, and thalassemia groups consisted of 219,627,117,383, and 9376 women, respectively. RESULTS: Multiparous women with severe anemia were at an increased risk of gestational hypertension (adjusted odds ratio (OR): 1.58; 95% confidence interval (CI): 1.15-2.19). Severe anemia had a significant association with preeclampsia/eclampsia for nulliparous (OR: 3.55; 95% CI: 2.87-4.41) and multiparous (OR: 3.94; 95% CI: 3.05-5.09) women. Sickle cell disease exhibited a significant association with gestational hypertension among nulliparous (OR: 2.49; 95% CI: 1.46-4.25) and multiparous (OR: 3.27; 95% CI: 2.33-4.58) women. No significant associations were found between sickle cell disease and preeclampsia/eclampsia, or between thalassemia and either gestational hypertension or preeclampsia/eclampsia. CONCLUSION: Severe anemia appears to be a risk factor for preeclampsia/eclampsia, while sickle cell disease appears to be a risk factor for gestational hypertension among women seeking hospital care in developing countries.

Synopsis of preterm birth genetic association studies: the preterm birth genetics knowledge base (PTBGene).

AIM: Our goal wasto produce a field synopsis of genetic associations with preterm birth and to set up a publicly available online database summarizing the data. METHODS: We performed a systematic review and meta-analyses to identify genetic associations with preterm birth. We have set up a publicly available online database of genetic association data on preterm birth called PTBGene (http://ric.einstein.yu.edu/ptbgene/index.html) and report on a structured synopsis thereof as of December 1, 2008. RESULTS: Data on 189 polymorphisms in 84 genes have been included and 36 meta-analyses have been performed. Five gene variants (4 in maternal DNA, one in newborn DNA) have shown nominally significant associations, but all have weak epidemiological credibility. CONCLUSION: After publishing this field synopsis, the PTBGene database will be regularly updated to keep track of the evolving evidence base of genetic factors in preterm birth with the goal of promoting knowledge sharing and multicenter collaboration among preterm birth research groups.

World Health Organisation multicentre randomised trial of supplementation with vitamins C and E among pregnant women at high risk for pre-eclampsia in populations of low nutritional status from developing countries.

OBJECTIVE: To determine if vitamin C and E supplementation in high-risk pregnant women with low nutritional status reduces pre-eclampsia. DESIGN: Multicentred, randomised, controlled, double-blinded trial. SETTING: Antenatal care clinics and Hospitals in four countries. POPULATION: Pregnant women between 14 and 22 weeks' gestation. METHOD: Randomised women received 1000 mg vitamin C and 400 iu of vitamin E or placebo daily until delivery. MAIN OUTCOME MEASURES: Pre-eclampsia, low birthweight, small for gestational age and perinatal death. RESULTS: Six hundred and eighty-seven women were randomised to the vitamin group and 678 to the placebo group. Groups had similar gestational ages (18.1; SD 2.4 weeks), socio-economic, clinical and demographical characteristics and blood pressure at trial entry. Risk factors for eligibility were similar, except for multiple pregnancies: placebo group (14.7%), vitamins group (11.8%). Previous pre-eclampsia, or its complications, was the most common risk factor at entry (vitamins 41.6%, placebo 41.3%). Treatment compliance was 87% in the two groups and loss to follow-up was low (vitamins 2.0%, placebo 1.3%). Supplementation was not associated with a reduction of pre-eclampsia (RR: 1.0; 95% CI: 0.9-1.3), eclampsia (RR: 1.5; 95% CI: 0.3-8.9), gestational hypertension (RR: 1.2; 95% CI: 0.9-1.7), nor any other maternal outcome. Low birthweight (RR: 0.9; 95% CI: 0.8-1.1), small for gestational age (RR: 0.9; 95% CI: 0.8-1.1) and perinatal deaths (RR: 0.8; 95% CI: 0.6-1.2) were also unaffected. CONCLUSION: Vitamins C and E at the doses used did not prevent pre-eclampsia in these high-risk women.

Safety of ultrasonography in pregnancy: WHO systematic review of the literature and meta-analysis.

OBJECTIVE: In the context of the planned International Society of Ultrasound in Obstetrics and Gynecology-World Health Organization multicenter study for the development of fetal growth standards for international application, we conducted a systematic review and meta-analysis to evaluate the safety of human exposure to ultrasonography in pregnancy. METHODS: A systematic search of electronic databases, reference lists and unpublished literature was conducted for trials and observational studies that assessed short- and long-term effects of exposure to ultrasonography, involving women and their fetuses exposed to ultrasonography, using B-mode or Doppler sonography during any period of pregnancy, for any number of times. The outcome measures were: (1) adverse maternal outcome; (2) adverse perinatal outcome; (3) abnormal childhood growth and neurological development; (4) non-right handedness; (5) childhood malignancy; and (6) intellectual performance and mental disease. RESULTS: The electronic search identified 6716 citations, and 19 were identified from secondary sources. A total of 61 publications reporting data from 41 different studies were included: 16 controlled trials, 13 cohort and 12 case-control studies. Ultrasonography in pregnancy was not associated with adverse maternal or perinatal outcome, impaired physical or neurological development, increased risk for malignancy in childhood, subnormal intellectual performance or mental diseases. According to the available clinical trials, there was a weak association between exposure to ultrasonography and non-right handedness in boys (odds ratio 1.26; 95% CI, 1.03-1.54). CONCLUSION: According to the available evidence, exposure to diagnostic ultrasonography during pregnancy appears to be safe.

Calcium supplementation during pregnancy for preventing hypertensive disorders is not associated with changes in platelet count, urate, and urinary protein: a randomized control trial.

OBJECTIVE: To test the hypothesis that calcium supplementation inhibits the underlying pathological processes in women with preeclampsia. METHODS: Seven hundred and eight nulliparous women were enrolled in a WHO randomized double-blind trial, who received 1.5 g of calcium or placebo from 20 weeks of pregnancy or earlier. Platelet count, serum urate, and urinary protein/creatinine ratio were measured at or near 35 gestational weeks. RESULTS: No difference was detected in rates of abnormal platelet count (relative risk [RR] 1.18; 95% confidence interval [CI], 0.63 to 2.18), serum urate level (1.0; 0.64 to 1.57) or urine protein/creatinine ratio (1.01; 0.76 to 1.34). This was consistent with the main trial finding of no difference in the incidence of 'dipstick' proteinuria between women receiving calcium and those receiving placebo (8312 women; RR, 1.01; 95% CI, 0.88 to 1.15). CONCLUSIONS: An effect of calcium supplementation in the second half of pregnancy on the rate of abnormal laboratory measures associated with preeclampsia was not demonstrated.

Fetal growth in Peru: comparisons with international fetal size charts and implications for fetal growth assessment.

OBJECTIVES: To compare fetal biometry measurements obtained in a Peruvian population with reference fetal size charts obtained in Peruvian and non-Peruvian populations. METHODS: Fetal biometry measurements collected prospectively in 195 uncomplicated pregnancies were included in the presented analysis. At 20, 24, 28, 32, 36 and 38 weeks' gestation, fetal head circumference, abdominal circumference and femur diaphysis length were measured. Fetal biometry measurements were compared with fetal size charts obtained from another Peruvian and two non-Peruvian populations from North America and Europe. RESULTS: When compared with ultrasound-based reference fetal size charts obtained from North American and European populations, fetuses from the studied population appeared to grow more slowly with advancing gestational age. This trend was not observed when a Peruvian population, similar to the one studied here, was used as a reference. CONCLUSIONS: The results suggest that fetal growth in this Peruvian population may not be adequately assessed by using reference charts obtained from other populations and have implications for the use of growth standards in antenatal management.

Methodological and technical issues related to the diagnosis, screening, prevention, and treatment of pre-eclampsia and eclampsia.

In contrast with advances made in treating or eliminating many other serious disorders, severe morbidity and mortality associated with pre-eclampsia/eclampsia remain among the leading problems that threaten safe motherhood, particularly in developing countries. This article reviews technical issues related to diagnosis, screening, prevention, and treatment of pre-eclampsia and identifies corresponding needs. The authors stress the lack of standardized definitions of pre-eclampsia and eclampsia and discuss problems in blood-pressure measurements and assessment of urinary protein. They summarize the evidence for prevention strategies and screening tests for early detection. For treatment, magnesium sulfate has been proven effective, but not widely used. The authors outline priorities for narrowing the identified gaps and emphasize the need for coordinated efforts to reduce the morbidity and mortality due to pre-eclampsia/eclampsia. They conclude that the mystery of this disease must be resolved to achieve primary prevention of it.

Adding zinc to prenatal iron and folate tablets improves fetal neurobehavioral development.

OBJECTIVE: Our objective was to examine whether improvement in maternal zinc status during pregnancy is positively associated with fetal neurobehavioral development in a Peruvian population. STUDY DESIGN: We electronically monitored, at 32 and 36 weeks' gestation, 55 fetuses whose mothers were randomly assigned to receive, during pregnancy, a daily supplement containing 60 mg iron and 250 microg folate, with or without 15 mg zinc. Fetal heart rate and movement patterns were quantified in 55 and 34 fetuses, respectively, as indexes of neurobehavioral development. RESULTS: Fetuses of mothers who received zinc supplementation showed fewer episodes of minimal fetal heart rate variability, increased fetal heart rate range, an increased number of accelerations, an increased number of movement bouts, an increased amount of time spent moving, and an increased number of large movements. Differences by supplementation type increased with gestational age and were statistically significant at 36 weeks' gestation (P <.05). CONCLUSION: Improving maternal zinc status through prenatal supplementation may improve fetal neurobehavioral development.

Potential contribution of maternal zinc supplementation during pregnancy to maternal and child survival.

Mild-to-moderate zinc deficiency may be relatively common worldwide, but the public health importance of this degree of zinc deficiency is not well defined. The purpose of this review was to provide a conceptual framework for evaluating the public health importance of maternal zinc deficiency as it relates to fetal growth and development, complications of pregnancy, labor and delivery, and maternal and infant health. The mechanisms through which zinc deficiency could influence health outcomes are well described. The results of experimental studies conducted in animal models have motivated concern about the potential health effects of mild-to-moderate maternal zinc deficiency. Observational studies in human populations have produced strong associations between poor maternal zinc status and various indicators of poor pregnancy outcome, but supplementation trials have not produced strong, or even consistent results. Supplementation trials are needed to define the public health importance of maternal zinc deficiency worldwide.

[Resectoscopic endometrial ablation in the treatment of recurrent, dysfunctional menometrorrhagia: our experience]. / L'ablazione di endometrio tramite resettoscopio nel trattamento delle menometrorragie recidivanti disfunzionali: nostra esperienza.

UNLABELLED: Advances in hysteroscopic surgery provide additional options to hysterectomy for the treatment of dysfunctional uterine bleeding resistant to medical therapy and multiple curettages. Two techniques are now available: (a) Resectoscopic endometrial ablation. (b) Electrocoagulation or laser photovaporisation of endometrium. 52 patients underwent resectoscopic endometrial ablation at the Gynaecology Department of Parma University from January 1991 to April 1993. All patients suffered from dysfunctional uterine bleeding without atypical histologic findings on endometrial biopsies and had a normal shaped uterine cavity. 41 patients were subsequently contacted for follow-up. Follow-up period ranged from a minimum of 3 months to a maximum of 24 months. 78.1% of the patients reported a satisfactory outcome (amenorrhea or decreased menstrual flow). No operative complication occurred. Post operative complications included one case of hematometra. CONCLUSIONS: resectoscopic endometrial ablation is an advantageous technique but our follow-up period is relatively short and long term sequelae have yet to be determined.