Liver biomarkers in adults: Evaluation of associations with reported green tea consumption and use of green tea supplements in U.S. NHANES.

Some events of hepatotoxicity have been linked to consumption of green tea supplements. The association between consumption of green tea or green tea supplements and abnormal liver biomarkers in adults was investigated using cross-sectional data from the 2009-2014 United States National Health and Nutrition Examination Survey (U.S. NHANES). Individuals with levels of either bilirubin or GGT, ALT, AST, and/or ALP in excess of the age- and gender-specific upper limits of normal ranges were classified as having abnormal liver biomarkers. Associations between green tea or green tea supplement use (consumption vs. not) and liver function were determined using multiple logistic regression modelling. 12,289 persons were included in the green tea analyses and 12,274 in the green tea supplement analyses. The odds of having one or more abnormal liver biomarkers were significantly reduced (p = 0.01) with consumption of green tea (OR: 0.49; 95% CI: 0.28, 0.85), while no significant association (p = 0.78) was determined for consumption of green tea supplements (OR: 0.92; 95% CI: 0.52, 1.64). Based on data from the 2009-2014 U.S. NHANES, green tea consumption was associated with reduced odds of having one or more abnormal liver biomarkers; whereas, no significant association was determined with consumption of green tea supplements.

'Accepting where I'm at' - a qualitative study of the mechanisms, benefits, and impact of a behavioral memory intervention for community-dwelling older adults.

OBJECTIVE: Gain novel, in-depth insight into therapeutic mechanisms, benefits, and impact of a multi-modal behavioral memory intervention for older adults with concerns about memory. METHODS: Participants were11 community-dwelling older adults (aged 63-88) who completed the Memory and Aging Program, an evidence-based multi-modal group intervention for normal age-related memory change. Semi-structured interviews were administered post-intervention. Responses were analyzed using qualitative content analysis until meaningful themes were agreed upon. RESULTS: Analyses revealed a main theme of normalization as the overarching benefit of participation. The mechanism for this comprised both specific intervention content and the process of participating with others. A positive impact of the intervention was demonstrated at emotional (feelings of reassurance, hope, and confidence) and functional (increasing motivation for lifestyle change) levels; for some, there was a direct link between emotion and function. CONCLUSION: This study highlighted a single, prominent therapeutic benefit of normalization, illustrated a dual mechanism for achieving this, and characterized a nuanced inter-relationship of the emotional and functional impact of the intervention for participants. Results support the notion that group behavioral interventions can educate, empower, and promote psychological well-being in older adults and may be an effective avenue to reduce risk of disease and promote sustained functional independence.

An open-label, acute clinical trial in adults to assess ketone levels, gastrointestinal tolerability, and sleepiness following consumption of (R)-1,3-butanediol (Avela™).

Introduction: A study was undertaken to determine the acute effects of a beverage made with Avela™ (R)-1,3-butanediol, on blood beta-hydroxybutyrate (BHB) levels (using the Keto-Mojo monitor), gastrointestinal (GI) tolerability (using the modified visual analogue scale GI Symptoms Tool), and sleepiness (using the Stanford Sleepiness Scale). Methods: Following a 12-h overnight fast, 26 healthy adults consumed one beverage containing 11.5 g of (R)-1,3-butanediol at each of 0, 30, and 60 min, culminating in a total intake of 34.5 g of (R)-1,3-butanediol. Blood BHB levels, GI tolerability, and sleepiness were assessed at baseline (0 min), and at 30, 60, 90, 120, 180, 240, and 300 min. At 240 min, a protein bar was consumed. Results: The mean (±SD) BHB fasting baseline level, maximal concentration, time at maximal concentration, and incremental area under the curve over 300 min were 0.23 ± 0.21 mmol/L, 2.10 ± 0.97 mmol/L, 133.85 ± 57.07 min, and 376.73 ± 156.76 mmol/L*min, respectively. BHB levels at each time point were significantly increased relative to baseline. In females, BHB Tmax was significantly greater (p = 0.046), and BHB iAUC0-300 min nearly significantly greater (p = 0.06) than in males. Discussion: The beverage formulated with Avela™ had no impact on sleepiness and was generally well-tolerated, with no or mild GI symptoms reported in most participants. Mild headaches were reported as an adverse event by five participants and judged possibly related to the study product in two of the participants.

Low- and no-calorie sweetener intakes in the Brazilian population estimated using added sugar substitution modelling.

This research examined the intakes of six low- and no-calorie sweeteners (LNCS) (acesulfame-K, aspartame, cyclamate, saccharin, steviol glycosides, and sucralose) by the Brazilian population using an added sugar substitution approach. Detailed exposure modelling requires the use of proprietary concentration data, which can be difficult to obtain. Two exposure models were conducted using nationally representative food consumption data. The first model ('per person') estimated added sugar intakes on an individual person basis, replacing 50% of added sugar intakes >10% total energy with each LNCS considering sucrose sweetness equivalence. The second model ('per food') replaced 50% of the added sugar content in foods and beverages with each LNCS, incorporating sucrose sweetness equivalence and Brazilian tonnage data. Both models predicted that intakes would be below the JECFA ADI for five of the six LNCS in all population groups examined (≥10 years) for average and heavy consumers. For cyclamate, exceedance of the ADI was determined for all age groups amongst heavy consumers in the 'per person' model, while estimated intakes in the 'per food' model were below or reached the ADI for the cohort. Additional research is needed for younger age groups to confirm whether these findings are applicable to the entire Brazilian population.

Babies admitted to NICU/ICU: province of birth and mode of delivery matter.

Neonatal intensive care units (NICUs) and intensive care units (ICUs) provide care for newborns in need of specialized medical attention. Across Canada, rates of NICU/ICU admission vary. Due to the high cost of monitoring and interventions these admissions cost more than general newborn stays - whether the newborn is in a specialized NICU or in an ICU in those facilities without specialized units for newborns. This study explores the variation in NICU/ICU admissions and the characteristics of mothers and newborns associated with an increased likelihood of NICU/ICU admission. We focus further on the association between NICU/ICU admission and Caesarean section (C-section). After excluding multiple births, preterm births, small for gestational age births and those delivered by women with select complications, we find an increased risk for NICU/ICU admission for babies born by C-section as their only indication. NICU/ICU admission following C-section alone may not represent the most desirable pathway of care for these newborns.

CIHI survey: bariatric surgery in Canada.

Bariatric surgery is a treatment option for obese patients when weight-reduction strategies such as lifestyle modifications and pharmacotherapy fail. To date, bariatric surgery has resulted in sustained weight loss; the resolution of diabetes for some patients has also been observed. The objective of this study was to explore changes in-patient bariatric surgery delivery in Canada between 2004-2005 and 2008-2009.

Bariatric surgery in Canada: a focus on day surgery procedures.

Given the rise in obesity rates, increasing capacity for bariatric surgery has become a focus for some provincial planners. Four types of bariatric procedures are now performed in Canada; however, funding for the procedures varies by jurisdiction. This article provides an update to our previous article documenting the volume of in-patient bariatric procedures but focuses on the extent to which Canadians are increasingly receiving bariatric procedures in day surgery settings.

Contribution of 100% Fruit Juice to Micronutrient Intakes in the United States, United Kingdom and Brazil.

The contribution of 100% fruit juice (FJ) to the total daily intakes of energy, sugars, and select vitamins and minerals and to the recommended dietary allowances (RDAs) or adequate intake (AI) of these micronutrients was assessed in individuals reporting the consumption of 100% FJ in the national dietary intake surveys of the United States (U.S.; n = 8661), the United Kingdom (UK; n = 2546) and Brazil (n = 34,003). Associations of 100% FJ intake with the odds of being overweight or obese also were assessed. Data from the U.S. National Health and Nutrition Examination Survey (2013-2014), the UK National Diet and Nutrition Survey (2012-2014), and Brazil's Pesquisa de Orçamentos Familiares (2008-2009) were used, and all analyses were limited to individuals reporting consumption of 100% FJ on at least one day of the dietary intake survey. Approximately 34%, 37%, and 42% of individuals surveyed reported the consumption of 100% FJ on at least one day of the dietary intake survey in the U.S., UK, and Brazil, respectively, and the average daily intakes of 100% FJ were 184 g, 130 g, and 249 g, respectively. Across the 3 countries, 100% FJ contributed to 3-6% of total energy intakes, 12-31% of total sugar intakes, 21-54% of total vitamin C intakes, 1-12% of total vitamin A intakes, 4-15% of total folate intakes, 7-17% of total potassium intakes, 2-7% of total calcium intakes, and 4-12% of total magnesium intakes. In a multivariate logistic regression model, juice intake was associated with a significant reduction in the odds of being overweight or obese in UK adults (OR = 0.79; 0.63, 0.99), and significant increases in the odds of being overweight or obese in UK children (OR = 1.16; 1.01, 1.33) and Brazilian adults (OR = 1.04; 1.00, 1.09). Nutrient contributions of 100% FJ vary according to regional intake levels. In all three countries studied, 100% FJ contributed to more than 5% of the RDAs for vitamin C and folate. In the U.S. and Brazil, 100% FJ contributed to more than 5% of the RDA for magnesium and more than 5% of the AI for potassium.

Predictive value of clinical and EEG features in the diagnosis of stroke and hypoxic ischemic encephalopathy in neonates with seizures.

BACKGROUND AND PURPOSE: In neonates, the differentiation of stroke and hypoxic ischemic encephalopathy (HIE) is important. Neuroimaging presents technical challenges in unstable neonates, resulting in frequently delayed or missed diagnosis of stroke. Differentiating clinical and electroencephalographic (EEG) features would assist physicians in the timely diagnosis. We sought to determine, in neonates with seizures, clinical and EEG features that differentiate stroke and HIE. METHODS: Retrospective cohort study comparing clinical, seizure, and EEG features in term neonates with ischemic stroke or HIE and seizures within 7 days after birth, admitted at The Hospital for Sick Children. Putative clinical and EEG predictors of stroke were analyzed with univariate and multivariate methods. RESULTS: Sixty-two newborns with stroke (n=27) or HIE (n=35) were studied. With univariate analysis, predictors of stroke included delayed seizure onset (>or=12-hours after birth) (P<0.0001; OR, 26.4; 95% CI, 6.8, 102.5), focal motor seizures (P=0.001; OR, 7.2; 95% CI, 2.0, 26.0) and pattern of neurological abnormalities (P<0.0001). With multivariate analysis, delayed seizure onset (P<0.0001; OR 39.7; 95% CI, 7.3, 217.0) and focal motor seizures (P=0.007; OR, 13.4; 95% CI, 2.1, 87.9) predicted stroke. Presence of both predictors had 100% positive predictive value and specificity, 61% negative predictive value and 37% sensitivity. CONCLUSIONS: In neonates, onset of seizures beyond 12 hours of birth and clinically observed focal seizures are predictive of stroke. These preinvestigation indicators of stroke may facilitate earlier diagnosis and institution of specific management strategies.

Estimating number of clusters based on a general similarity matrix with application to microarray data.

Many clustering methods require that the number of clusters believed present in a given data set be specified a priori, and a number of methods for estimating the number of clusters have been developed. However, the selection of the number of clusters is well recognized as a difficult and open problem and there is a need for methods which can shed light on specific aspects of the data. This paper adopts a model for clustering based on a specific structure for a similarity matrix. Publicly available gene expression data sets are analyzed to illustrate the method and the performance of our method is assessed by simulation.

Usefulness of improvement in walking distance versus peak oxygen uptake in predicting prognosis after myocardial infarction and/or coronary artery bypass grafting in men.

Information is limited on the influence of a change in fitness and/or physical activity on mortality in cardiac patients who undergo exercise rehabilitation. This was studied in 6,956 men (4,713 with myocardial infarctions, 2,243 who underwent coronary bypass surgery) completing a 12-month walking-based training regimen and followed for a median of 9 years (range 4 to 26; 67,820 patient-years). Peak oxygen uptake (VO2peak) was measured at the beginning and the end of the program, and walking distance and pace were recorded weekly. These and other pertinent data were entered into a Cox proportional-hazards model and tested for associations with time to cardiac and all-cause death. In total, 2,016 deaths were recorded (737 cardiac, 1,279 all-cause). The mean increase in VO2peak was 4.9 ml/kg/min (95% confidence interval [CI] 4.7 to 5.0, p <0.0001), and the mean increase in distance walked was 2.1 mi (95% CI 2.0 to 2.1, p <0.0001). Increase in VO2peak was significant on univariate analysis (hazard ratio [HR] 0.98) but not on multivariate analysis. Distance increase was a significant predictor of cardiac and all-cause death on multivariate analysis, with each 1-mi improvement conferring a 20% reduction in cardiac death (HR 0.80, 95% CI 0.71 to 0.87, p <0.0001). When categorized into groups of <1.3 (referent), 1.3 to 2.8, and >2.8 mi, increased walking distance of 1.3 to 2.8 and of >2.8 mi yielded 24% (HR 0.76, 95% CI 0.62 to 0.92, p = 0.005) and 48% (HR 0.52, 95% CI 0.40 to 0.68, p <0.0001) reductions in cardiac death, respectively. In conclusion, in men who underwent an exercise rehabilitation program, improvement in walking distance was a strong independent predictor, and a greater guide to prognosis, than gains in VO2peak.

Complications of exteriorized compared with in situ uterine repair at cesarean delivery under spinal anesthesia: a randomized controlled trial.

OBJECTIVE: To compare intraoperative complications of exteriorized and in situ uterine repair during elective cesarean delivery under spinal anesthesia. METHODS: This study was a randomized, single-blinded trial in 80 women undergoing elective cesarean delivery under spinal anesthesia. Patients were randomly assigned to exteriorized or in situ uterine repair. Obstetricians were asked to perform assisted delivery of the placenta. Spinal anesthesia and oxytocin management were standardized. Phenylephrine was used to maintain systolic blood pressure within 10% of the baseline. The primary outcome was intraoperative, postdelivery nausea or vomiting. RESULTS: Postdelivery nausea or vomiting (18% compared with 38%; P=.04) and tachycardia (3% compared with 18%; P=.03) were significantly reduced in the in situ group compared with the exteriorized group. The duration of uterine repair was significantly shorter in the exteriorized group (median 10 minutes [first and third quartiles 9, 13], compared with 11 minutes [9, 15]) (P=.04). The duration of surgery (36 minutes [30, 41] compared with 37 minutes [30, 45]) and estimated blood loss (mean+/-standard deviation 625+/-489 mL compared with 653+/-416 mL) were similar between the in situ and the exteriorized groups. There was no correlation between duration of uterine repair and estimated blood loss. CONCLUSION: Exteriorization of the uterus for repair is associated with an increased incidence of nausea and vomiting and tachycardia during cesarean delivery under spinal anesthesia. Uterine repair should be done in situ where possible. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00452972 LEVEL OF EVIDENCE: I.

Usefulness of a placental profile in high-risk pregnancies.

OBJECTIVE: Test the hypothesis that a placental function profile can reassure most high-risk women with normal test results yet accurately can identify a subset of women who are destined for major complications that will be attributable to placental disease. STUDY DESIGN: This was a prospective study of 212 high-risk pregnancies that used the placental profile (16- to 18-week maternal serum screening, 18- to 23-week uterine artery Doppler imaging, and placental morphologic condition). Odds ratios (95% CI) were derived for intrauterine fetal death (IUFD), preterm delivery at < 34 weeks of gestation, preeclampsia/hemolysis, elevated liver enzymes, and low platelet count syndrome (HELLP) syndrome, small for gestational age delivery, and early-onset intrauterine growth restriction (IUGR); all normal test results (n =125) were compared with > or = 1 abnormal test results. RESULTS: The odds of the development of adverse outcomes were significantly less in women with all normal test results (preeclampsia/HELLP [odds ratio, 0.2; 95% CI, 0.1-0.4]), preterm delivery (odds ratio, 0.1; 95% CI, 0.06-0.3), small for gestational age delivery (odds ratio, 0.2; 95% CI, 0.09-0.3), early-onset IUGR (0), and IUFD (odds ratio, 0.05 [0.01-0.2]). Combining those women with two (n = 21) of 3 (n = 15) abnormal test results together predicted 14 of 19 severe IUGR and 15 of 22 IUFD cases. CONCLUSION: This placental function profile at 16-23 weeks of gestation can reassure women with normal test results by identifying a smaller subset of women who are at reduced risk of perinatal morbidity or death from severe IUGR.

A randomized controlled trial of a bedside partogram in the active management of primiparous labour.

OBJECTIVE: The partogram is a pictorial representation of the progress of labour, used in an effort to enhance early recognition of dystocia and help avoid Caesarean section (CS). The objective of this study was to evaluate the effect of partogram use on the CS and obstetric intervention rates. METHODS: We conducted a randomized controlled trial of use of the partogram in 1932 primiparous women with uncomplicated pregnancies at term. Patients were randomly assigned to one of two groups: the standard group, who had the progress of labour charted in written notes, or the partogram group, whose progress in labour was recorded using a bedside graphical partogram as well as in written notes. Outcomes were stratified according to whether labour was spontaneous or induced and whether membranes were initially intact or ruptured. The primary outcome was the rate of CS; secondary outcome measures were rates of obstetric intervention for dystocia. RESULTS: There was no significant difference between the groups in rates of CS (partogram 24%, standard notes 25%), rates of other interventions, amniotomy, oxytocin use, or the mean cervical dilatation in labour. CONCLUSION: In this study, the use of a partogram without a mandatory management of labour protocol had no effect on rates of CS or other intrapartum interventions in healthy primiparous women at term.

Minimum oxytocin dose requirement after cesarean delivery for labor arrest.

OBJECTIVE: To estimate the minimum effective intravenous dose of oxytocin required for adequate uterine contraction after cesarean delivery for labor arrest. METHODS: A randomized single-blinded study was undertaken in 30 parturients undergoing cesarean deliveries under epidural anesthesia for labor arrest despite intravenous oxytocin augmentation. Oxytocin was administered as a slow intravenous bolus immediately after delivery of the infant, according to a biased coin up-down sequential allocation scheme. After assisted spontaneous delivery of the placenta, the obstetrician, blinded to the oxytocin dose, assessed uterine contraction as either satisfactory or unsatisfactory. Additional boluses of oxytocin were administered as required, followed by a maintenance infusion. Data were interpreted and analyzed by a logistic regression model at 95% confidence intervals. RESULTS: All patients received oxytocin infusions at a mean +/- standard deviation of 9.8 +/- 6.3 hours before cesarean delivery (maximum infusion dose 10.3 +/- 8.2 mU/min). The minimum effective dose of oxytocin required to produce adequate uterine response in 90% of women (ED90) was estimated to be 2.99 IU (95% confidence interval 2.32-3.67). The estimated blood loss was 1,178 +/- 716 mL. CONCLUSION: Women requiring cesarean delivery for labor arrest after oxytocin augmentation require approximately 3 IU rapid intravenous infusion of oxytocin to achieve effective uterine contraction after delivery. This dose is 9 times more than previously reported after elective cesarean delivery in nonlaboring women at term, suggesting oxytocin receptor desensitization from exogenous oxytocin administration during labor. Therefore, alternative uterotonic agents, rather than additional oxytocin, may achieve superior uterine contraction and control of blood loss during cesarean delivery for labor arrest. LEVEL OF EVIDENCE: I.

Assessment of Intakes and Patterns of Cooked Oatmeal Consumption in the U.S. Using Data from the National Health and Nutrition Examination Surveys.

The objective of the present study was to characterize the consumption of cooked oatmeal in the United States (U.S.) and to determine whether oatmeal consumption is associated with body mass index (BMI). To estimate current intakes of cooked oatmeal in the various age and gender population groups, we used dietary intake data from Day 1 of the U.S. 2009-2010 and 2011-2012 National Health and Nutrition Examination Surveys (NHANES). We also used dietary intake data from Day 1 of the U.S. 2003-2012 NHANES to assess associations between intakes of cooked oatmeal (in g/kg body weight) and NHANES cycle (2003-2004, 2005-2006, 2007-2008, 2009-2010, 2011-2012), age category (3-11 years, 12-18 years, 19-44 years, 45 years+), gender, and BMI classification (underweight, normal weight, overweight, or obese), using a multiple linear regression model. A consumer of oatmeal was defined as any individual who reported the consumption of any amount of oatmeal on Day 1 of the survey. Approximately 6% of the total population consumed oatmeal, with an average intake of 238 g/day of cooked oatmeal among consumers. The greatest prevalence of oatmeal consumption was in infants (14.3%) and older female adults (11.1%). Amongst oatmeal consumers, underweight, normal weight, and overweight individuals consumed significantly more oatmeal than obese individuals. Oatmeal was consumed almost exclusively at breakfast and, among consumers, contributed an average of 54.3% of the energy consumed at breakfast across all age groups examined. The association between oatmeal consumption and BMI is interesting and requires confirmation in future clinical studies.

Slow Stream Rehabilitation: A New Model of Post-Acute Care.

OBJECTIVES: To identify characteristics and outcomes of elderly patients admitted to a slow stream, low-intensity, and long-duration inpatient rehabilitation (SSR) program after an acute hospitalization because they were unable to tolerate traditional inpatient rehabilitation. DESIGN: Single group pre-post study with assessments conducted on admission and discharge. SETTING: Baycrest's 30-bed SSR Unit in Toronto, Ontario, Canada. PARTICIPANTS: A total of 104 patients older than 60 years admitted between September 2011 and December 2012. MEASUREMENTS: Admission assessments included demographic data, Functional Independence Measure (FIM), and ability to ambulate. Discharge outcomes included change in motor and total FIM scores from admission to discharge, discharge residential status, and length of stay. RESULTS: Mean age was 81.6 ± 8.4 years and 68.3% were women. Mean changes in motor and total FIM were 21.0 ± 12.2 (P < .001) and 22.6 ± 14.0 (P < .001), respectively. On admission, only 30.8% of patients were ambulatory even with mobility assistive devices, while on discharge, 68.3% of patients were ambulatory; 61.5% of patients returned to their preadmission living arrangement; 8.6% went from their own home to a retirement or relative's home. Only 16.3% were discharged to long-term nursing home care and 13.4% were transferred to an acute hospital. Mean length of SSR stay was 82.5 ± 26.4 days. CONCLUSION: SSR programs can benefit elderly patients at risk for institutionalization after acute hospitalization by improving their functioning and mobility, and allowing them to return to the community.

Agreement of carbon dioxide levels measured by arterial, transcutaneous and end tidal methods in preterm infants < or = 28 weeks gestation.

OBJECTIVE: To assess the agreement of transcutaneous carbon dioxide (TcPCO(2)) and end tidal carbon dioxide (PetCO(2)) with arterial carbon dioxide (PaCO(2)) values in infants < 28 weeks gestational age. STUDY DESIGN: In all, 27 ventilated preterm infants were prospectively studied. PaCO(2) was compared with TcPCO(2) and PetCO(2) measured at three similar time points within first 24 hours after birth. RESULTS: The Intraclass correlation coefficients for TcPCO(2) and PaCO(2) were 0.45, 0.73 and 0.53; and for PetCO(2) and PaCO(2) were 0.61, 0.56 and 0.57 at 4, 12 and 24 hours after birth, respectively. CONCLUSION: A moderate agreement with a wide variation in individual values was observed between noninvasive methods and PaCO(2) in preterm infants in the first 24 hours. Noninvasive monitoring methods cannot be substituted for PaCO(2) analyses in preterm infants during this critical period.

Genome-wide linkage analysis of systolic blood pressure slope using the Genetic Analysis Workshop 13 data sets.

Systolic blood pressure (SBP) is an age-dependent complex trait for which both environmental and genetic factors may play a role in explaining variability among individuals. We performed a genome-wide scan of the rate of change in SBP over time on the Framingham Heart Study data and one randomly selected replicate of the simulated data from the Genetic Analysis Workshop 13. We used a variance-component model to carry out linkage analysis and a Markov chain Monte Carlo-based multiple imputation approach to recover missing information. Furthermore, we adopted two selection strategies along with the multiple imputation to deal with subjects taking antihypertensive treatment. The simulated data were used to compare these two strategies, to explore the effectiveness of the multiple imputation in recovering varying degrees of missing information, and its impact on linkage analysis results. For the Framingham data, the marker with the highest LOD score for SBP slope was found on chromosome 7. Interestingly, we found that SBP slopes were not heritable in males but were for females; the marker with the highest LOD score was found on chromosome 18. Using the simulated data, we found that handling treated subjects using the multiple imputation improved the linkage results. We conclude that multiple imputation is a promising approach in recovering missing information in longitudinal genetic studies and hence in improving subsequent linkage analyses.

Intrathecal plain vs hyperbaric bupivacaine for labour analgesia: efficacy and side effects.

PURPOSE: Baricity is an important determinant of block characteristics of the spinal component of a combined spinal epidural (CSE) for labour analgesia. This study compares the analgesic efficacy and side effects of intrathecally administered plain and hyperbaric bupivacaine (both with fentanyl) during active labour. METHODS: Sixty-two women in active labour (cervical dilatation >or=5 cm and pain score > 5) were randomized in a prospective, single-blinded fashion to receive 2.5 mg of either hyperbaric or plain bupivacaine both combined with 15 microg of fentanyl as the spinal component of a CSE. The primary outcome was failure of satisfactory analgesia within ten minutes of the intrathecal injection as defined by a verbal pain score > 3. Secondary outcomes included need for rescue analgesia, hypotension, respiratory depression, nausea and vomiting, pruritus and sustained fetal bradycardia. RESULTS: Sixty patients were analyzed. The failure rates were 20% in the hyperbaric group vs 0% in the plain group (P=0.024). The plain solution provided faster onset, higher sensory levels and less motor block at all times during the first 30 min. The incidence of both pruritus and sustained fetal bradycardia was 33% in the plain group and 10% in the hyperbaric group (P=0.03). CONCLUSION: A plain rather than hyperbaric solution of bupivacaine 2.5 mg with fentanyl 15 microg provides a faster onset of analgesia, higher sensory levels and less motor block, while demonstrating an increased incidence of pruritus and sustained fetal bradycardia.