Feasibility study to assess the delivery of a lifestyle intervention (TreatWELL) for patients with colorectal cancer undergoing potentially curative treatment.

OBJECTIVES: To assess the feasibility of delivering and evaluating a lifestyle programme for patients with colorectal cancer undergoing potentially curative treatments. STUDY DESIGN: Non-randomised feasibility trial. SETTING: National Health Service (NHS) Tayside. PARTICIPANTS: Adults with stage I-III colorectal cancer. INTERVENTION: The 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 OUTCOME: Feasibility measures (recruitment, retention, programme implementation, achieved measures, fidelity, factors affecting protocol adherence and acceptability). SECONDARY OUTCOMES: Measured changes in body weight, waist circumference, walking and self-reported physical activity, diet, smoking, alcohol intake, fatigue, bowel function and quality of life. RESULTS: Of 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. CONCLUSIONS: To 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 NUMBER: ISRCTN52345929; Post-results.

Feasibility study to assess the impact of a lifestyle intervention ('LivingWELL') in people having an assessment of their family history of colorectal or breast cancer.

OBJECTIVES: To assess the feasibility of delivering and evaluating a weight management (WM) programme for overweight patients with a family history (FH) of breast cancer (BC) or colorectal cancer (CRC). STUDY DESIGN: A two-arm (intervention vs usual care) randomised controlled trial. SETTING: National Health Service (NHS) Tayside and NHS Grampian. PARTICIPANTS: People with a FH of BC or CRC aged≥18 years and body mass index of ≥25 kg/m2 referred to NHS genetic services. INTERVENTION: Participants were randomised to a control (lifestyle booklet) or 12-week intervention arm where they were given one face-to-face counselling session, four telephone consultations and web-based support. A goal of 5% reduction in body weight was set, and a personalised diet and physical activity (PA) programme was provided. Behavioural change techniques (motivational interviewing, action and coping plans and implementation intentions) were used. PRIMARY OUTCOME: Feasibility measures: recruitment, programme implementation, fidelity measures, achieved measurements and retention, participant satisfaction assessed by questionnaire and qualitative interviews. SECONDARY OUTCOMES: Measured changes in weight and PA and reported diet and psychosocial measures between baseline and 12-week follow-up. RESULTS: Of 480 patients approached, 196 (41%) expressed interest in the study, and of those, 78 (40%) patients were randomised. Implementation of the programme was challenging within the time allotted and fidelity to the intervention modest (62%). Qualitative findings indicated the programme was well received. Questionnaires and anthropometric data were completed by >98%. Accelerometer data were attained by 84% and 54% at baseline and follow-up, respectively. Retention at 12 weeks was 76%. Overall, 36% of the intervention group (vs 0% in control) achieved 5% weight loss. Favourable increases in PA and reduction in dietary fat were also reported. CONCLUSIONS: A lifestyle programme for people with a family history of cancer is feasible to conduct and acceptable to participants, and indicative results suggest favourable outcomes. TRIAL REGISTRATION NUMBER: ISRCTN13123470; Pre-results.

Cancer prevention-the feasibility and acceptability of promoting breast cancer risk reduction in the screening setting through a lifestyle magazine.

Cancer prevention and early detection strategies are fundamental to reducing breast cancer burden. Offering prevention guidance on modifiable risk factors within early detection settings is rare. We aimed to evaluate the acceptability of a magazine focused on lifestyle and cancer prevention for use in breast screening clinics. A lifestyle magazine was developed and distributed within two breast screening settings in the West of Scotland over a 2-month period. Women were either offered the magazine on arrival or in a self-service format. Uptake was recorded by NHS staff. Women's views were sought via an evaluation questionnaire. Staff were interviewed on their experiences of intervention delivery. Uptake was greatest when offered to attendees (95% vs. 20% self-service). The evaluation questionnaire response rate was 17.3%. Almost 60% of respondents reported an increased knowledge about breast cancer and lifestyle and felt motivated to find out more about cancer prevention and 40% expressed intentions to make lifestyle changes. Over 90% of respondents thought lifestyle factors were important in breast cancer prevention. Staff feedback was positive, indicating no detrimental effects on workloads. In conclusion, a cancer prevention lifestyle magazine can be successfully delivered in the breast screening setting and deserves further exploration for roll out.

Health Behaviors and their Relationship with Disease Control in People Attending Genetic Clinics with a Family History of Breast or Colorectal Cancer.

The current work aimed to assess health behaviors, perceived risk and control over breast/colorectal cancer risk and views on lifestyle advice amongst attendees at cancer family history clinics. Participants attending the East of Scotland Genetics Service were invited to complete a questionnaire (demographic data, weight and height, health behaviors and psycho-social measures of risk and perceived control) and to participate in an in-depth interview. The questionnaire was completed by 237 (49 %) of attendees, ranging from 18 to 77 years (mean age 46 (±10) years). Reported smoking rates (11 %) were modest, most (54 %) had a BMI > 25 kg/m2, 55 % had low levels of physical activity, 58 % reported inappropriate alcohol intakes and 90 % had fiber intakes indicative of a low plant diet. Regression analysis indicated that belief in health professional control was associated with higher, and belief in fatalism with poorer health behavior. Qualitative findings highlighted doubts about the link between lifestyle and cancer, and few were familiar with the current evidence. Whilst lifestyle advice was considered interesting in general there was little appetite for non-tailored guidance. In conclusion, current health behaviors are incongruent with cancer risk reduction guidance amongst patients who have actively sought advice on disease risk. There are some indications that lifestyle advice would be welcomed but endorsement requires a sensitive and flexible approach, and the acceptability of lifestyle interventions remains to be explored.

Awareness of Lifestyle and Colorectal Cancer Risk: Findings from the BeWEL Study.

It is estimated that 47% of colorectal cancers (CRC) could be prevented by appropriate lifestyles. This study aimed to identify awareness of the causes of CRC in patients who had been diagnosed with a colorectal adenoma through the Scottish Bowel Screening Programme and subsequently enrolled in an intervention trial (using diet and physical activity education and behavioural change techniques) (BeWEL). At baseline and 12-month follow-up, participants answered an open-ended question on factors influencing CRC development. Of the 329 participants at baseline, 40 (12%) reported that they did not know any risk factors and 36 (11%) failed to identify specific factors related to diet and activity. From a potential knowledge score of 1 to 6, the mean score was 1.5 (SD 1.1, range 0 to 5) with no difference between intervention and control groups. At follow-up, the intervention group had a significantly greater knowledge score and better weight loss, diet, and physical activity measures than the control group. Awareness of relevant lifestyle factors for CRC remains low in people at increased risk of the disease. Opportunities within routine NHS screening to aid the capability (including knowledge of risk factors) of individuals to make behavioural changes to reduce CRC risk deserve exploration.

Why are some people more successful at lifestyle change than others? Factors associated with successful weight loss in the BeWEL randomised controlled trial of adults at risk of colorectal cancer.

BACKGROUND: The BeWEL (BodyWEight and physicaL activity) randomised controlled trial demonstrated that a weight management programme offered in the colorectal cancer screening setting was effective. However, the differential responses of participants to the programme were notable. This study aimed to explore the factors associated with success and to identify implications for future programme design. METHODS: Analyses were conducted of quantitative data (n = 148) from the BeWEL intervention group to compare demographic and psychosocial characteristics and lifestyle changes in those who met and exceeded the target 7% weight loss ('super-achievers') with those who achieved only 'moderate' or 'low' amounts of weight loss (2-7% loss, or <2% loss, respectively). In-depth qualitative interviews (n = 24) explored in detail the motivations, actions, pathways to weight loss and circumstances of study participants. RESULTS: Over the 12 month intervention period, mean percentage weight loss of super-achievers (n = 33) was 11.5%, compared with moderate-achievers (n = 58) who lost 4.2%, and low-achievers (n = 57) who gained 0.8%. Compared to other groups, super- achievers increased their fruit and vegetable intake (p < 0.01) and physical activity (step count, p < 0.01). 'Super-achievers' did not differ in baseline demographic characteristics from other participants. However, significantly fewer reported that their activities were limited by physical and emotional health and they were more likely to perceive their current diet as harmful. Qualitative analyses found no consistent patterns among super-achievers in relation to some factors identified as important in previous studies, such as social support. However, super-achievers shared several characteristics such as determination and consistency in their engagement with the intervention, receptivity to new information and prompts, previous positive experience of changing health behaviours, being motivated by early success, making changes routine, and an ability to devise and apply strategies for dealing with setback and 'relapse' triggers. CONCLUSIONS: Successful lifestyle change depends on active engagement as well as effective intervention ingredients. Weight loss interventions are likely to be more effective where they can adapt to participants' differing characteristics and needs, while also providing core elements likely to build success.

Breast cancer risk reduction--is it feasible to initiate a randomised controlled trial of a lifestyle intervention programme (ActWell) within a national breast screening programme?

BACKGROUND: Breast cancer is the most commonly diagnosed cancer and the second cause of cancer deaths amongst women in the UK. The incidence of the disease is increasing and is highest in women from least deprived areas. It is estimated that around 42% of the disease in post-menopausal women could be prevented by increased physical activity and reductions in alcohol intake and body fatness. Breast cancer control endeavours focus on national screening programmes but these do not include communications or interventions for risk reduction. This study aimed to assess the feasibility of delivery, indicative effects and acceptability of a lifestyle intervention programme initiated within the NHS Scottish Breast Screening Programme (NHSSBSP). METHODS: A 1:1 randomised controlled trial (RCT) of the 3 month ActWell programme (focussing on body weight, physical activity and alcohol) versus usual care conducted in two NHSSBSP sites between June 2013 and January 2014. Feasibility assessments included recruitment, retention, and fidelity to protocol. Indicative outcomes were measured at baseline and 3 month follow-up (body weight, waist circumference, eating and alcohol habits and physical activity). At study end, a questionnaire assessed participant satisfaction and qualitative interviews elicited women's, coaches, and radiographers' experiences. Statistical analysis used Chi squared tests for comparisons in proportions and paired t tests for comparisons of means. Linear regression analyses were performed, adjusted for baseline values, with group allocation as a fixed effect. RESULTS: A pre-set recruitment target of 80 women was achieved within 12 weeks and 65 (81%) participants (29 intervention, 36 control) completed 3 month assessments. Mean age was 58 ± 5.6 years, mean BMI was 29.2 ± 7.0 kg/m(2) and many (44%) reported a family history of breast cancer. The primary analysis (baseline body weight adjusted) showed a significant between group difference favouring the intervention group of 2.04 kg (95% CI -3.24 kg to -0.85 kg). Significant, favourable between group differences were also detected for BMI, waist circumference, physical activity and sitting time. Women rated the programme highly and 70% said they would recommend it to others. CONCLUSIONS: Recruitment, retention, indicative results and participant acceptability support the development of a definitive RCT to measure long term effects. TRIAL REGISTRATION: The trial was registered with Current Controlled Trials (ISRCTN56223933).

The impact of a bodyweight and physical activity intervention (BeWEL) initiated through a national colorectal cancer screening programme: randomised controlled trial.

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 MEASURES: The 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 interval 2.70 to 4.30) in the intervention group compared with 0.78 kg (SD 3.77) (0.19 to 1.38) in the control group. The group difference was 2.69 kg (95% confidence interval 1.70 to 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. CONCLUSIONS: Significant 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.

Recruiting and retaining postpartum women from areas of social disadvantage in a weight-loss trial--an assessment of strategies employed in the WeighWell feasibility study.

Little is known about the response of post-partum women from deprived backgrounds to weight management interventions, however behavioural intervention trials in disadvantaged communities are often characterised by recruitment difficulties. Recruitment and retention is key to the robust conduct of an effective trial, and exploratory work is essential prior to a definitive randomised controlled trial. This paper describes strategies used to recruit to the WeighWell feasibility study, which aimed to recruit 60 overweight or obese post-partum women living in areas of deprivation to a trial of a weight-loss intervention. Recruitment strategies included the following: (1) distribution of posters and 'business cards'; (2) newspaper advertisements; (3) visits to community groups; and (4) personalised letters of invitation sent via the National Health Service (NHS). Potential participants were screened for eligibility following response to a Freephone number. Body mass index was calculated using self-reported body weight and height. Over 6 months, 142 women responded of whom 65 (46%) met the eligibility criteria. The most effective methods for recruiting eligible women and those who went on to complete the study (n = 36) were visits to community groups (37% and 42%, respectively), personalised letters (26% and 17%, respectively) and posters and 'business cards' (22% and 31%, respectively). These results emphasise the need to utilise a range of strategies beyond traditional NHS settings. Current approaches might be enhanced by sending personal contact letters via their General Practitioner to women identified as eligible at post-natal discharge. Under-reporting of body weight by self-report suggests that a threshold lower than 25 kg/m(2) should be utilised for screening purposes.

Provision of weight management advice for obese women during pregnancy: a survey of current practice and midwives' views on future approaches.

A semi-structured, web-based questionnaire was developed to survey midwives (n = 241) employed by NHS Tayside, UK, to identify current practice and views on weight management of obese women during pregnancy and the puerperium. A total of 78 (32%) midwives submitted responses following email invitation. Most respondents (79%) reported always calculating women's body mass index (BMI) at booking, with 73% routinely explaining the BMI category. In terms of future practice for obese women, although few respondents (15%) currently offer personalised advice regarding weight management based on a woman's diet and physical activity levels, 77% of respondents thought such advice would be appropriate and 69% thought it could possibly be feasible to offer such advice. The respondents viewed weight management to be of importance and felt that universal advice is appropriate, but confidence in discussing weight management and knowledge of the subject was low. Strategies to improve midwife confidence and weight management services should include training, ongoing support and definition of the midwife's role within the multidisciplinary team to support practice in the future.

A feasibility study of a personalised lifestyle programme (HealthForce) for individuals who have participated in cardiovascular risk screening.

OBJECTIVE: To assess the feasibility of a lifestyle intervention, focusing on diet and activity, in adults participating in cardiovascular screening. METHODS: The 12-week lifestyle intervention comprised three personalised counselling sessions plus telephone contact. Outcome data were collected by anthropometry, activity monitoring and lifestyle questionnaires. Acceptability of study measures was assessed by questionnaire and the intervention delivery by in-depth interviews. RESULTS: Between June 2008 and March 2009, 75 (62%) of 121 eligible individuals were recruited from Tayside, Scotland. Randomisation was to intervention (IV) (n=55) or comparison group (CG) (n=20). Retention was 99% across both groups. In the IV group, 63% increased moderate-vigorous activity by ≥ 30 minutes/week, 82% successfully maintained or lost weight (mean loss 1.1 kg, and 2.6 cm waist circumference) and 85% reported eating five portions of fruit and vegetables compared with 56% at baseline. No behaviour changes were detected in the CG. Feedback highlighted the value of lifestyle "checks," realising that current habits were sub-optimal, receiving personalised advice on specific behaviours, and feeling "healthier" through participation. CONCLUSIONS: HealthForce was feasible to deliver and implement, acceptable to participants, and associated with reported changes in health behaviours over a 12-week period.

A cohort study of maternal and neonatal morbidity in relation to use of sequential instruments at operative vaginal delivery.

OBJECTIVE: To evaluate the risk factors and maternal and neonatal morbidity associated with sequential use of instruments (vacuum and forceps) at operative vaginal delivery. STUDY DESIGN: A cohort study of 1360 nulliparous women delivered by a single instrument (vacuum or forceps) or by both instruments, within two university teaching hospitals in Scotland and England. Outcomes were compared for use of sequential instruments versus use of any single instrument. A sub-group analysis compared sequential instruments versus forceps alone. Outcomes of interest included anal sphincter tears, postpartum haemorrhage, urinary retention, urinary incontinence, prolonged hospital admission, neonatal trauma, low Apgar scores, abnormal cord bloods and admission to the neonatal intensive care unit (NICU). RESULTS: Use of sequential instruments at operative vaginal delivery was associated with fetal malpositions, Odds Ratio (OR) 1.8 (95% Confidence Interval (CI) 1.3-2.6), and large neonatal head circumference (>37 cm) (OR 5.0, 95% CI 2.6-9.7) but not with maternal obesity or grade of operator. Sequential use of instruments was associated with greater maternal and neonatal morbidity than single instrument use (anal sphincter tear 17.4% versus 8.4%, adjusted OR 2.1, 95% CI 1.2-3.3; umbilical artery pH <7.10, 13.8% versus 5.0%, adjusted OR 3.3, 95% CI 1.7-6.2). Sequential instrument use had greater morbidity than single instrument use with forceps alone (anal sphincter tear OR 1.8, 95% CI 1.1-2.9; umbilical artery pH <7.10 OR 3.0, 95% CI 1.7-5.5). CONCLUSIONS: The use of sequential instruments significantly increases maternal and neonatal morbidity. Obstetricians need training in the appropriate selection and use of instruments with the aim of completing delivery safely with one instrument.

Relationship between maternal arterial wave reflection, microvascular function and fetal growth in normal pregnancy.

OBJECTIVE: In 50 normotensive pregnancies, we examined the relationship between fetal growth, arterial wave reflection, and microvascular function at 22, 34 weeks gestation, and six weeks postpartum. METHODS: Arterial wave reflection was determined by measuring augmentation index (AIx). Changes in skin microcirculation to acetylcholine (ACh) and sodium nitroprusside (SNP) were assessed using laser Doppler imaging. RESULTS: At 22 weeks, birth weight centile correlated with AIx adjusted for maternal age, MAP, heart rate and timing of reflected wave (r = -0.363, p = 0.012), and with ACh responses (r = 0.317, p = 0.022). ACh responses correlated with adjusted AIx (r = -0.420, p = 0.003). At 34 weeks, birth weight centile correlated with the adjusted AIx (r = -0.301, p = 0.048). ACh responses were borderline correlated with adjusted AIx (r = -0.323, p = 0.074). At six weeks postpartum, no significant correlations were found between birth weight centile, AIx, and ACh responses. SNP responses did not correlate with AIx or birth weight centile at any time point. CONCLUSION: During normal pregnancy, changes in vascular function might reflect important adaptations that are required to facilitate normal fetal growth. This was highlighted in the present study by the findings of a positive correlation between birth weight and endothelial function and a negative correlation between birth weight and arterial wave reflection.

Implementation of guidelines on oxytocin use at caesarean section: a survey of practice in Great Britain and Ireland.

OBJECTIVE: Caesarean section is one of the most commonly performed major operations on women worldwide. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. Various clinical guidelines address oxytocin use at the time of caesarean section. We previously reported wide variation in practice amongst clinicians in the United Kingdom in the use of oxytocin at caesarean section. The aim of this current study was to determine whether the variation in approach is universal across the individual countries of Great Britain and Ireland and whether this reflects differences in interpretation and implementation of clinical practice guidelines. STUDY DESIGN: We conducted a survey of practice in the five individual countries of Great Britain and Ireland. A postal questionnaire was sent to all lead consultant obstetricians and anaesthetists with responsibility for the labour ward. We explored the use of oxytocin bolus and infusion, the measurement of blood loss at caesarean section and the rates of major haemorrhage. Existing clinical guidelines from the National Institute for Clinical Excellence (NICE), the Royal College of Obstetricians and Gynaecologists (RCOG) and ALSO (Advanced Life Support in Obstetrics) were used to benchmark reported practice against recommended practice for the management of blood loss at caesarean section. RESULTS: The response rate was 82% (391 respondents). Use of a 5 IU oxytocin bolus was reported by 346 respondents (85-95% for individual countries). In some countries, up to 14% used a 10 IU oxytocin bolus despite recommendations against this. Routine use of an oxytocin infusion varied greatly between countries (11% lowest-55% highest). Marked variations in choice of oxytocin regimens were noted with inconsistencies in the country-specific recommendations, e.g. NICE (which covers England and Wales) recommends a 30 IU oxytocin infusion over 4h, but only 122 clinicians (40%) used this. CONCLUSIONS: Clinicians' approach to the use of oxytocin at the time of caesarean delivery varies between countries. Even in countries with on-site visits to ensure guideline implementation (e.g. Clinical Negligence Scheme for Trusts in England), deviations from guideline recommendations exist. These variations may reflect a lack of robust evidence and the need for future research in this area.

Use of oxytocin to prevent haemorrhage at caesarean section--a survey of practice in the United Kingdom.

OBJECTIVE: To establish the views and current practice of obstetricians and anaesthetists with regard to the use of oxytocin to prevent haemorrhage at caesarean section. STUDY DESIGN: A national survey of all lead consultant obstetricians and anaesthetists for the labour ward in the United Kingdom. A postal questionnaire was sent to all clinicians with one subsequent reminder to non-responders. The use of oxytocin bolus and infusion, perceived side effects of intravenous oxytocin, estimated blood loss at caesarean section, and willingness to participate in a future clinical trial were explored. RESULTS: The response rate was 84% (365 respondents). A slow bolus of 5 IU oxytocin was the preferred approach of obstetricians and anaesthetists (153, 86% and 171, 92%, respectively). Oxytocin infusions were used routinely by 72 clinicians (20%) with selective use for particular clinical circumstances by 289 (80%). Most clinicians used either 30 IU (158, 43%) or 40 IU (192, 53%) infusions over 4h, with a total of 38 different regimens. The perceived risk of side effects with an oxytocin infusion was low. Estimated "average" blood loss varied (150-1,500 ml) with 56 clinicians (17%) and 93 (28%) reporting a >20% risk of postpartum haemorrhage for elective and emergency caesarean sections, respectively. CONCLUSION: There is wide variation in the use of oxytocin at caesarean section reflecting limited research in this area. Excess haemorrhage is considered to occur frequently and the perceived risk of oxytocin bolus and infusion is low. Further research is required addressing the optimal use of oxytocic agents at caesarean section.

Operative vaginal delivery and the use of episiotomy--a survey of practice in the United Kingdom and Ireland.

OBJECTIVE: To establish the views and current practice of obstetricians with regard to operative vaginal delivery and the use of episiotomy. STUDY DESIGN: A national survey of consultant obstetricians and specialist registrars practising in the United Kingdom and Ireland registered with the Royal College of Obstetricians and Gynaecologists (RCOG), London. A postal questionnaire was sent to all obstetricians with two subsequent reminders to non-responders. The choice of procedure for specific circumstances, instrument preference, use of episiotomy and views on the relationship between episiotomy use and anal sphincter tears at operative vaginal delivery were explored. RESULTS: The response rate was 80.4%. Instrument preference varied according to the fetal position and station and the grade of operator. Vacuum and forceps were both used for mid-cavity non-rotational deliveries (64% and 56% reported frequent use respectively). Rotational vacuum was preferred for a mid-cavity mal-position (69%) followed by equal numbers using rotational forceps or manual rotation and forceps (34% and 36%, respectively). Inexperienced operators were more likely to proceed directly to caesarean section (35%). A restrictive approach to use of episiotomy was preferred for vacuum delivery (72%) and a routine approach for forceps (73%). Obstetricians varied greatly in their perception of the relationship between episiotomy use and anal sphincter tears at operative vaginal delivery. CONCLUSION: There is wide variation in the use of episiotomy at operative vaginal delivery with uncertainty about its role in preventing anal sphincter tears. A randomised controlled trial would address this important aspect of obstetric care.

Decision-making about mode of delivery after previous caesarean section: development and piloting of two computer-based decision aids.

OBJECTIVE: To develop and pilot two computer-based decision aids to assist women with decision-making about mode of delivery after a previous caesarean section (CS), which could then be evaluated in a randomized-controlled trial. BACKGROUND: Women with a previous CS are faced with a decision between repeat elective CS and vaginal birth after caesarean. Research has shown that women may benefit from access to comprehensive information about the risks and benefits of the delivery options. DESIGN: A qualitative pilot study of two novel decision aids, an information program and a decision analysis program, which were developed by a multidisciplinary research team. PARTICIPANTS AND SETTING: 15 women who had recently given birth and had previously had a CS and 11 pregnant women with a previous CS, recruited from two UK hospitals. Women were interviewed and observed using the decision aids. RESULTS: Participants found both decision aids useful and informative. Most liked the computer-based format. Participants found the utility assessment of the decision analysis program acceptable although some had difficulty completing the tasks required. Following the pilot study improvements were made to expand the program content, the decision analysis program was accompanied by a training session and a website version of the information program was developed to allow repeat access. CONCLUSIONS: This pilot study was an essential step in the design of the decision aids and in establishing their acceptability and feasibility. In general, participating women viewed the decision aids as a welcome addition to routine antenatal care. A randomized trial has been conducted to establish the effectiveness and cost-effectiveness of the decision aids.

Changes in endothelial function precede the clinical disease in women in whom preeclampsia develops.

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 Doppler waveforms at 18 to 20 weeks, and controls with normal Doppler waveforms. Fifty-four women remained normotensive and preeclampsia developed in 15. In normotensive and preeclamptic women, acetylcholine responses were augmented during pregnancy compared with postpartum responses (P<0.001). Sodium nitroprusside responses were augmented during pregnancy compared with those postpartum (P<0.005) in preeclamptic women only. Microvascular responses were augmented in women in whom preeclampsia developed, compared with those in normotensive women, at 26 and 34 weeks for acetylcholine (P<0.05 and P<0.001, respectively) and at 22 and 26 weeks for sodium nitroprusside (P<0.05 and P<0.02, respectively). Postpartum acetylcholine and sodium nitroprusside responses were not significantly different between preeclamptic and normal women. Microvascular responses are enhanced during pregnancy in women in whom preeclampsia develops to a level above that seen in normotensive women. These changes precede the onset of clinical disease and might be related to a compensatory increased sensitivity of the microcirculation to nitric oxide.

MMP-2 levels are elevated in the plasma of women who subsequently develop preeclampsia.

OBJECTIVE: To determine levels of matrix metalloproteinase (MMP)-2 and MMP-9, and the tissue inhibitors of metalloproteinases (TIMP)-1 and TIMP-2 in the plasma of women destined to develop preeclampsia prior to the onset of clinical disease. STUDY DESIGN: Plasma samples were taken from women whose pregnancies were subsequently complicated by preeclampsia and from normal pregnant women at 22 and 26 weeks and at delivery or diagnosis. Following equal protein loading, MMP-2 and 9 and TIMP-1 and 2 were quantified using zymography and Western blot analysis, respectively. RESULTS: Plasma MMP-2 levels were significantly elevated at 22 weeks (p = 0.02) and at diagnosis (p = 0.003) in the preeclampsia group, but there was no difference at 26 weeks. TIMP-1 levels were significantly reduced in the preeclampsia group at 26 weeks (p = 0.0002), but TIMP-2 levels were not quantifiable. CONCLUSION: 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.

Cohort study of maternal and neonatal morbidity in relation to use of episiotomy at instrumental vaginal delivery.

OBJECTIVE: The aim of this study was to investigate the maternal and neonatal morbidity related to use of episiotomy for vacuum and forceps deliveries. DESIGN: Retrospective population-based cohort study. SETTING: Dundee, Scotland. POPULATION: Two thousand one hundred and fifty three women who experienced an instrumental vaginal delivery between January 1998 and December 2002. METHODS: Univariate and multivariate logistic regression analyses were performed comparing deliveries with and without the use of episiotomy. MAIN OUTCOME MEASURES: Extensive perineal tears (third and fourth degree) and shoulder dystocia. RESULTS: Two hundred and forty-one (11%) of the 2153 women who underwent instrumental vaginal deliveries did not receive an episiotomy. Vacuum delivery was associated with less use of episiotomy compared with forceps (odds ratio 0.10, 95% CI 0.07-0.14). Extensive perineal tears were more likely with use of episiotomy (7.5%vs 2.5%, adjusted OR 2.92, 95% CI 1.27-6.72) as was neonatal trauma (6.0%vs 1.7%, adjusted OR 2.62, 95% CI 1.05-6.54). Use of episiotomy did not reduce the risk of shoulder dystocia (6.9%vs 4.6%, adjusted OR 1.43, 95% CI 0.74-2.76). The findings were similar for delivery by vacuum and forceps. CONCLUSION: The use of episiotomy increased the risk of extensive perineal tears without a reduction in the risk of shoulder dystocia.