Objective To evaluate the impact of a diet and physical activity intervention (BeWEL) on weight change in people with a body mass index >25 weight (kg)/height (m) 2 at increased risk of colorectal cancer and other obesity related comorbidities.Design Multicentre, parallel group, randomised controlled trial.Setting Four Scottish National Health Service health boards.Participants 329 overweight or obese adults (aged 50 to 74 years) who had undergone colonoscopy after a positive faecal occult blood test result, as part of the national bowel screening programme, and had a diagnosis of adenoma confirmed by histopathology. 163 were randomised to intervention and 166 to control.Intervention Participants were randomised to a control group (weight loss booklet only) or 12 month intervention group (three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls).A goal of 7% reduction in body weight was set and participants received a personalised energy prescription (2508 kJ (600 kcal) below that required for weight maintenance) and bodyweight scales. Motivational interviewing techniques explored self assessed confidence, ambivalence, and personal values concerning weight. Behavioural strategies included goal setting, identifying intentions of implementation, self monitoring of body weight, and counsellor feedback about reported diet, physical activity, and weight change. Main outcome measuresThe primary outcome was weight change over 12 months. Secondary outcomes included changes in waist circumference, blood pressure, fasting cardiovascular biomarkers, and glucose metabolism variables, physical activity, diet, and alcohol consumption.Results At 12 months, data on the primary outcome were available for 148 (91%) participants in the intervention group and 157 (95%) in the control group. Mean weight loss was 3.50 kg (SD 4.91) (95% confidence 3.67). Differences between groups were significant for waist circumference, body mass index, blood pressure, blood glucose level, diet, and physical activity. No reported adverse events were considered to be related to trial participation. ConclusionsSignificant weight loss can be achieved by a diet and physical activity intervention initiated within a national colorectal cancer screening programme, offering considerable potential for risk reduction of disease in older adults.Trial registration Current Controlled Trials ISRCTN53033856. IntroductionColorectal cancer is the third most common cancer and cause of cancer related death in the United Kingdom. 1 Most cases (95%) occur in people aged over 50, who often have other lifestyle related comorbidities, such as obesity, type 2 diabetes mellitus, and cardiovascular disease.2 3 These diseases share common risk factors, including increased waist circumference, altered glucose metabolism, and abnormal lipid levels. Consistent with findings for cardiovascular disease and type 2 diabetes mellitus, 6 7 high levels of body fat (body mass index >23 (weight (kg)/height (m)2 )) or a large waist circumferenc...
Objective To compare the maternal and neonatal outcomes of operative vaginal delivery in relation to the use of episiotomy. Design Pilot randomised controlled trial (RCT).Setting Two urban maternity units in Scotland and England.Sample Nulliparous women anticipating a singleton cephalic vaginal delivery were recruited in the antenatal period.Methods If an operative vaginal delivery was required in the second stage of labour, women were randomised to either routine (in all cases) or restrictive (only if tearing apparent) use of episiotomy.Main outcome measures The primary outcome was anal sphincter tearing (third or fourth degree). Secondary outcomes included postpartum haemorrhage (PPH), neonatal trauma and pelvic floor symptoms up until 10 days postpartum.Results In a group of 317 women requiring operative vaginal delivery, 200 were randomised: 99 to routine use of episiotomy and 101 to restrictive use. There were small differences in the rates of anal sphincter tears (8.1% routine versus 10.9% restrictive, OR 0.72, 95% CI 0.28-1.87) and primary PPH (36.4% routine versus 26.7% restrictive, OR 1.57, 95% CI 0.86-2.86). Neonatal trauma was similar between the two groups (45.5% routine versus 43.6% restrictive, OR 1.08, 95% CI 0.62-1.89), as was prolonged catheterisation, urinary incontinence, faecal incontinence, perineal infection and prolonged hospital admission.Conclusions This pilot study does not provide conclusive evidence that a policy of routine episiotomy is better or worse than a restrictive policy. A definitive RCT is feasible but will require a large sample size to inform clinical practice.Keywords Anal sphincter tears, episiotomy, operative vaginal delivery, randomised controlled trial.Please cite this paper as: Murphy D, Macleod M, Bahl R, Goyder K, Howarth L, Strachan B. A randomised controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicentre pilot study.
At all three gestational time points an imbalance in the MMP-2:TIMP-1 ratio was found in patients who subsequently developed preeclampsia. We speculate that increased net MMP-2 activity may contribute to the endothelial dysfunction that is central to the pathophysiology of preeclampsia.
Objective To evaluate the maternal and neonatal morbidity of operative vaginal delivery in relation to the use of episiotomy.Design Prospective cohort study.Setting Two urban maternity units in Scotland and England.Population All nonrandomised nulliparous women delivered by forceps or vacuum during the recruitment period of a clinical trial evaluating the use of episiotomy at operative vaginal delivery.Methods Use of episiotomy was compared to no episiotomy for all operative vaginal deliveries with sub-group analyses for forceps or vacuum deliveries.Main outcome measures The primary outcome was anal sphincter tearing (third or fourth degree). Secondary outcomes included postpartum haemorrhage, neonatal trauma and pelvic floor symptoms up until 10 days postpartum.Results A total of 1360 women were included in the study, of whom 294 (21.6%) did not receive an episiotomy. Vacuum delivery was associated with less use of episiotomy than forceps (56.1 versus 89.4%, OR 0.15, 95% CI 0.11-0.20). Anal sphincter tear rates were not statistically different with use of episiotomy compared with no episiotomy (9.9 versus 7.1%, adjusted OR 1.11, 95% CI 0.66-1.87). Episiotomy use was associated with higher rates of postpartum haemorrhage (28.5 versus 18.4%, adjusted OR 1.72, 95% CI 1.21-2.45), need for moderate or strong analgesia (90.5 versus 67.6%, adjusted OR 3.70, 95% CI 2.60-5.27), perineal infection (5.1 versus 1.4%, adjusted OR 4.04, 95% CI 1.44-11.37) and neonatal trauma (38.1 versus 22.0%, adjusted OR 1.65, 95% CI 1.20-2.27). Use of episiotomy did not reduce the risk of shoulder dystocia (3.5 versus 1.7%, adjusted OR 1.42, 95% CI 0.53-3.85).Conclusions The use of episiotomy did not reduce or greatly increase anal sphincter tears and was associated with greater maternal and neonatal morbidity. This may reflect the complexity of deliveries. The role of episiotomy at operative vaginal delivery should be evaluated in a randomised controlled trial.Keywords Anal sphincter tear, episiotomy, operative vaginal delivery, prospective cohort study.
Abstract-Endothelial dysfunction is important in the pathophysiology of preeclampsia. No study has examined endothelial function sequentially at different gestations before development of the clinical syndrome and after delivery (to compare maternal from placental influences). We sought to determine whether endothelial function changes before the clinical development of preeclampsia. We measured skin microvascular function using iontophoresis of acetylcholine and sodium nitroprusside, and laser Doppler imaging at 22, 26, 34 weeks' gestation and 6 weeks postpartum in women identified as being at increased risk of preeclampsia, based on uterine artery Key Words: endothelium-derived factors Ⅲ hypertension Ⅲ microcirculation Ⅲ nitric oxide Ⅲ preeclampsia Ⅲ pregnancy P reeclampsia (PE) continues to be a leading cause of maternal and perinatal morbidity and mortality. Characteristic hemodynamic changes occur during normal human pregnancy, which include peripheral vasodilatation, reductions in total vascular resistance, and decreased arterial blood pressure. The precise reasons for such changes are not clear, but recent evidence points to changes in endothelial function and nitric oxide activity as contributory factors. 1,2 In PE there is accumulating evidence for a pathogenic model whereby deficient trophoblast invasion of the maternal spiral arteries leads to a poorly perfused feto-placental unit. 3 This results in secretion of a factor(s) by the placenta into the maternal circulation, which activates the vascular endothelium. 4,5 However, although endothelial dysfunction appears to be a key player in the pathophysiology of PE, there appears to be a difference in the way in which endothelial damage is expressed depending on the particular vascular bed studied. For example, arterial endothelial function, assessed using ultrasound measurements of flow-mediated dilatation, is diminished in women who have PE compared with normal pregnant women. 6 -8 Conversely in the microcirculation, endothelium-dependent vasodilatation is increased in women who have PE to levels over and above those seen in normal pregnancy. 9 After pregnancy, however, both arterial and microvascular endothelial functions are diminished in women who had PE. 10 -12 This suggests that either endothelial dysfunction is present before pregnancy and predisposes women to PE, or that PE induces long-term changes in endothelial function, which could have implications for development of cardiovascular disease in later life.There is no study however, that has examined vascular responses sequentially at different gestations before the clinical syndrome of PE develops and after delivery (to compare maternal from placental influences), and compared these changes to those in women who remain normotensive. The purpose of this study, therefore, was to measure endothelial function at 22, 26, and 34 weeks' gestation and 6 weeks postpartum in women identified as being at increased risk for PE, based on uterine artery Doppler waveforms at 18 to 20 weeks, and control sub...
BackgroundPregnancy is a life stage where excess weight gain may occur and the postpartum period is often characterised by weight retention. The aim of the current study was to evaluate the feasibility of undertaking a randomised controlled trial of a weight loss intervention (WeighWell) in postpartum women living in areas of social disadvantage.Subjects and methodsThe study aimed to recruit 60 women who were not pregnant, 6-18 months postpartum with a BMI >25kg/m2 living in areas of deprivation within Tayside, UK. Recruitment strategies focused on visits to community groups; writing directly to postpartum women living in areas of deprivation and primary care teams who covered the most deprived 15% of the population and advertising in community settings. The 12 week intervention used motivational interviewing techniques to promote an energy deficit diet and increased physical activity, delivered by 3 face to face consultations plus 3 structured telephone calls.ResultsOf 142 women screened, 63 were eligible and 52 (83%) were recruited and randomised to an intervention (n=29) or comparison group (n=23). Over the 12 week intervention, body weight changed significantly by −1.6 ± 2.0kg in the intervention group compared to +0.2 ± 2.2kg in the comparison group indicating the potential efficacy of the intervention. Loss to follow-up was 24% in the intervention group and 39% for the comparison group.ConclusionsThe findings support the development of a definitive trial that embraces personalised recruitment strategies and the development of approaches to improve retention over a clinically relevant intervention period.
Objective To compare the maternal and neonatal morbidity associated with alternative instruments used to perform a mid-cavity rotational delivery.Design A prospective cohort study.Setting Two university teaching hospitals in Scotland and England.Population Three hundred and eighty-one nulliparous women who had a mid-cavity rotational operative vaginal delivery.Methods A data collection sheet was completed by the research team following delivery.Main outcome measures Postpartum haemorrhage, thirdand fourth-degree perineal tears, low cord pH, neonatal trauma, and failed or sequential operative vaginal delivery.Results One hundred and sixty-three women (42.8%) underwent manual rotation followed by non-rotational forceps delivery, 73 (19.1%) had a rotational vacuum delivery, and 145 (38.1%) delivered with the assistance of rotational (Kielland) forceps. The rates of postpartum haemorrhage were similar when comparing manual rotation with rotational vacuum (adjusted OR 1.42, 95% CI 0.66-3.98), and when comparing manual rotation with Kielland forceps (adjusted OR 1.22, 95% CI 0.71-2.88). The results were comparable for third-and fourth-degree perineal tears (adjusted OR 0.85, 95% CI 0.13-1.89; adjusted OR 0.94, 95% CI 0.39-1.82), low cord pH (adjusted OR 1.76, 95% CI 0.44-6.91; adjusted OR 1.12, 95% CI 0.44-2.83), neonatal trauma (adjusted OR 0.50, 95% CI 0.16-1.55; adjusted OR 3.25, 95% CI 0.65-16.17), and admission to the neonatal intensive care unit (adjusted OR 1.47, 95% CI 0.45-4.81; adjusted OR 1.04, 95% CI 0.49-2.19). The sequential use of instruments was less likely with manual rotation and forceps than with rotational vacuum delivery (0.6 versus 36.9%, OR 0.01, 95% CI 0.002-0.090).Conclusions Maternal and perinatal outcomes are comparable with Kielland forceps, vacuum extraction, and manual rotation, with few serious adverse outcomes. With appropriate training mid-cavity rotational delivery can be practiced safely, including the use of Kielland forceps.Keywords Mid-cavity, morbidity, operative vaginal delivery, prospective cohort study, rotational.Please cite this paper as: Bahl R, Van de Venne M, Macleod M, Strachan B, Murphy DJ. Maternal and neonatal morbidity in relation to the instrument used for mid-cavity rotational operative vaginal delivery: a prospective cohort study . BJOG 2013;120:1526-1533
ObjectivesTo assess the feasibility of delivering and evaluating a lifestyle programme for patients with colorectal cancer undergoing potentially curative treatments.Study designNon-randomised feasibility trial.SettingNational Health Service (NHS) Tayside.ParticipantsAdults with stage I–III colorectal cancer.InterventionThe programme targeted smoking, alcohol, physical activity, diet and weight management. It was delivered in three face-to-face counselling sessions (plus nine phone calls) by lifestyle coaches over three phases (1: presurgery, 2: surgical recovery and 3: post-treatment recovery).Primary outcomeFeasibility measures (recruitment, retention, programme implementation, achieved measures, fidelity, factors affecting protocol adherence and acceptability).Secondary outcomesMeasured changes in body weight, waist circumference, walking and self-reported physical activity, diet, smoking, alcohol intake, fatigue, bowel function and quality of life.ResultsOf 84 patients diagnosed, 22 (26%) were recruited and 15 (18%) completed the study. Median time for intervention delivery was 5.5 hours. Coaches reported covering most (>70%) of the intervention components but had difficulties during phase 2. Evaluation measures (except walk test) were achieved by all participants at baseline, and most (<90%) at end of phase 2 and phase 3, but <20% at end of phase 1. Protocol challenges included limited time between diagnosis and surgery and the presence of comorbidities. The intervention was rated highly by participants but limited support from NHS staff was noted. The majority of participants (77%) had a body mass index>25 kg/m2 and none was underweight. Physical activity data showed a positive trend towards increased activity overall, but no other changes in secondary outcomes were detected.ConclusionsTo make this intervention feasible for testing as a full trial, further research is required on (a) recruitment optimisation, (b) appropriate assessment tools, (c) protocols for phase 2 and 3, which can build in flexibility and (d) ways for NHS staff to facilitate the programme.Trial registration numberISRCTN52345929; Post-results.
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