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PubMed2006

Impact of Helicobacter pylori eradication on dyspepsia, health resource use, and quality of life in the Bristol helicobacter project: randomised controlled trial.

OBJECTIVE: To determine the impact of a community based Helicobacter pylori screening and eradication programme on the incidence of dyspepsia, resource use, and quality of life, including a cost consequences analysis. DESIGN: H pylori screening programme followed by randomised placebo controlled trial of eradication. SETTING: Seven general practices in southwest England. PARTICIPANTS: 10,537 unselected people aged 20-59 years were screened for H pylori infection (13C urea breath test); 1558 of the 1636 participants who tested positive were randomised to H pylori eradication treatment or placebo, and 1539 (99%) were followed up for two years. INTERVENTION: Ranitidine bismuth citrate 400 mg and clarithromycin 500 mg twice daily for two weeks or placebo. MAIN OUTCOME MEASURES: Primary care consultation rates for dyspepsia (defined as epigastric pain) two years after randomisation, with secondary outcomes of dyspepsia symptoms, resource use, NHS costs, and quality of life. RESULTS: In the eradication group, 35% fewer participants consulted for dyspepsia over two years compared with the placebo group (55/787 v 78/771; odds ratio 0.65, 95% confidence interval 0.46 to 0.94; P = 0.021; number needed to treat 30) and 29% fewer participants had regular symptoms (odds ratio 0.71, 0.56 to 0.90; P = 0.05). NHS costs were 84.70 pounds sterling (74.90 pounds sterling to 93.91 pounds sterling) greater per participant in the eradication group over two years, of which 83.40 pounds sterling (146 dollars; 121 euro) was the cost of eradication treatment. No difference in quality of life existed between the two groups. CONCLUSIONS: Community screening and eradication of H pylori is feasible in the general population and led to significant reductions in the number of people who consulted for dyspepsia and had symptoms two years after treatment. These benefits have to be balanced against the costs of eradication treatment, so a targeted eradication strategy in dyspeptic patients may be preferable.

Adult↗
PubMed2026

Community-tailored One Health educational intervention to enhance knowledge and practices for zoonotic disease prevention in rural Thailand: A protocol for a prospective cluster randomised controlled Trial in Chanthaburi, Thailand (Saan Suk trial).

BACKGROUND: Zoonotic infectious disease risk arises at human-animal-environment interfaces where pathogen spillover can occur. Rural communities living in biodiverse settings may experience frequent contact with wildlife and shared environments through livelihoods, food practices, and economic activities. Reducing spillover risk and strengthening pandemic prevention requires both structural and individual-level change. Community-based interventions that promote awareness, risk perception, self-efficacy, pro-environmental behaviour, and safe coexistence with wildlife may support prevention by shifting behavioural determinants of zoonotic disease risk. The Saan Suk intervention was co-developed with rural communities in Thailand using a Human-Centred Design approach and is grounded in the Health Belief Model and One Health principles. The intervention is intended to be feasible, acceptable, and deliverable through Thailand's established Village Health Volunteer (VHV) system. METHODS: This protocol describes a parallel-arm, cluster-randomised controlled superiority trial that will be conducted during July - October 2026, in Chanthaburi Province, Thailand. 24 villages will be equally randomised to the Saan Suk intervention or the current practice (control). In intervention villages, trained VHVs will deliver, once a week over four weeks, a multimodal One Health educational intervention designed to improve knowledge of zoonotic spillover, promote protective behaviours, reduce risky wildlife-related contacts, and support respectful coexistence with wildlife. Trained outcome assessment teams will conduct structured interviews with 42 adult participants per village, yielding a total sample size of 1,008 participants. The sample size was calculated for the primary outcome, accounting for clustering, with 90% power to detect a medium effect size (6 points on the 0-100 knowledge scale) at a significance level of 0.05, accounting for a design effect with an ICC of 0.028. The primary outcome is knowledge of zoonotic spillover, transmission pathways, risk factors, protective and risky behaviours, and safe coexistence with wildlife. Secondary outcomes include attitudes, self-efficacy, preventive and risky behaviours, and reported contacts with major local reservoir hosts. A structured questionnaire was developed, expert-reviewed, and piloted for the outcome assessment. Outcomes will be analysed using mixed-effects regression models with random effects for village and adjustment for relevant pre-specified confounders. Primary analyses will follow the intention-to-treat principle. DISCUSSION: This trial will evaluate whether a co-designed, VHV-delivered One Health educational programme can improve knowledge of zoonotic disease prevention and behavioural determinants in rural communities living in close contact with wildlife and shared ecosystems. If effective and feasible, Saan Suk could inform integration into routine VHV training and community-based zoonotic disease and pandemic prevention strategies. TRIAL REGISTRATION: The Saan Suk trial is registered with the German Clinical Trials Register (DRKS). Registration ID: DRKS00038582; date of registration: 11 May 2026.

Zoonoses↗
PubMed2006

A randomised controlled trial evaluating the effects of two workstation interventions on upper body pain and incident musculoskeletal disorders among computer operators.

BACKGROUND: Call centre work with computers is associated with increased rates of upper body pain and musculoskeletal disorders. METHODS: This one year, randomised controlled intervention trial evaluated the effects of a wide forearm support surface and a trackball on upper body pain severity and incident musculoskeletal disorders among 182 call centre operators at a large healthcare company. Participants were randomised to receive (1) ergonomics training only, (2) training plus a trackball, (3) training plus a forearm support, or (4) training plus a trackball and forearm support. Outcome measures were weekly pain severity scores and diagnosis of incident musculoskeletal disorder in the upper extremities or the neck/shoulder region based on physical examination performed by a physician blinded to intervention. Analyses using Cox proportional hazard models and linear regression models adjusted for demographic factors, baseline pain levels, and psychosocial job factors. RESULTS: Post-intervention, 63 participants were diagnosed with one or more incident musculoskeletal disorders. Hazard rate ratios showed a protective effect of the armboard for neck/shoulder disorders (HR = 0.49, 95% CI 0.24 to 0.97) after adjusting for baseline pain levels and demographic and psychosocial factors. The armboard also significantly reduced neck/shoulder pain (p = 0.01) and right upper extremity pain (p = 0.002) in comparison to the control group. A return-on-investment model predicted a full return of armboard and installation costs within 10.6 months. CONCLUSION: Providing a large forearm support combined with ergonomic training is an effective intervention to prevent upper body musculoskeletal disorders and reduce upper body pain associated with computer work among call centre employees.

Adult↗
PubMed1998

Quantitative systematic review of randomised controlled trials comparing antibiotic with placebo for acute cough in adults.

OBJECTIVES: To assess whether antibiotic treatment for acute cough is effective and to measure the side effects of such treatment. DESIGN: Quantitative systematic review of randomised placebo controlled trials. DATA SOURCES: Nine trials (8 published, 1 unpublished) retrieved from a systematic search (electronic databases, contact with authors, contact with drug manufacturers, reference lists); no restriction on language. MAIN OUTCOME MEASURES: Proportion of subjects with productive cough at follow up (7-11 days after consultation with general practitioner); proportion of subjects who had not improved clinically at follow up; proportion of subjects who reported side effects from taking antibiotic or placebo. RESULTS: Eight trials contributed to the meta-analysis. Resolution of cough was not affected by antibiotic treatment (relative risk 0.85 (95% confidence interval 0.73 to 1.00)), neither was clinical improvement at re-examination (relative risk 0.62 (0.36 to 1.09)). The side effects of antibiotic were more common in the antibiotic group when compared to placebo (relative risk 1.51 (0.86 to 2.64)). CONCLUSIONS: Treatment with antibiotic does not affect the resolution of cough or alter the course of illness. The benefits of antibiotic treatment are marginal for most patients with acute cough and may be outweighed by the side effects of treatment.

Adult↗
PubMed2002

A randomised controlled trial to determine the effect of intensity of therapy upon length of stay in a neurological rehabilitation setting.

A randomised single-blind controlled trial was designed to determine whether intensity of therapy (physiotherapy and occupational therapy) shortened length of stay for patients in a rehabilitation unit. Patients were under 65, primarily with stroke, but also with other conditions such as traumatic brain injury, and multiple sclerosis. The experimental group were timetabled to receive 67% more therapy in any given week, than the control group. After controlling for confounders and case mix (as expressed by type of therapy required) patients in the experimental group showed a significant 14-day reduction in length of stay (<0.01). Concurrently average length of stay was increased for both groups by 16 days due to delays in discharge.

Adult↗
PubMed2003

Stress debriefing after childbirth: a randomised controlled trial.

OBJECTIVE: To test whether critical incident stress debriefing after childbirth reduces the incidence of postnatal psychological disorders. DESIGN: Randomised single-blind controlled trial stratified for parity and delivery mode. SETTING: Two large maternity hospitals in Perth. PARTICIPANTS: 1745 women who delivered healthy term infants between April 1996 and December 1997 (875 allocated to intervention and 870 to control group). INTERVENTION: An individual, standardised debriefing session based on the principles of critical incident stress debriefing carried out within 72 hours of delivery. MAIN OUTCOME MEASURES: Diagnosis of stress disorders or depression in the 12 months postpartum, using structured psychological interview and criteria of the Diagnostic and statistical manual of mental disorders, 4th edition. RESULTS: Follow-up information was available for 1730 women (99.1%), 482 of whom underwent psychological interview. There were no significant differences between control and intervention groups in scores on Impact of Events or Edinburgh Postnatal Depression Scales at 2, 6 or 12 months postpartum, or in proportions of women who met diagnostic criteria for a stress disorder (intervention, 0.6% v control, 0.8%; P = 0.58) or major or minor depression (intervention, 17.8% v control, 18.2%; relative risk [95% CI], 0.99 [0.87-1.11]) during the postpartum year. Nor were there differences in median time to onset of depression (intervention, 6 [interquartile range, 4-9] weeks v control, 4 [3-8] weeks; P = 0.84), or duration of depression (intervention, 24 [12-46] weeks v control, 22 [10-52] weeks; P = 0.98). CONCLUSIONS: There is a high prevalence of depression in women during the first year after childbirth. A session of midwife-led, critical incident stress debriefing was not effective in preventing postnatal psychological disorders, but had no adverse effects.

Crisis Intervention↗
PubMed2005

First trimester threatened miscarriage treatment with human chorionic gonadotrophins: a randomised controlled trial.

OBJECTIVE: To determine whether administration of exogenous human chorionic gonadotrophin (hCG) treatment improve the pregnancy outcome in first trimester threatened miscarriages. DESIGN: A prospective, double blind, randomised, placebo-controlled trial. SETTING: The Early Pregnancy Assessment Unit, Royal Bolton Hospital, Bolton, United Kingdom. POPULATION: One hundred and eighty-three women with vaginal bleeding and a viable fetus seen on ultrasound scan (USS) in the first 12 weeks of pregnancy. METHODS: The patients were randomised to receive either hCG or placebo treatment until 14 weeks of gestation. MAIN OUTCOME MEASURES: The primary objective of the trial was to determine the miscarriage rate in the hCG arm compared from the placebo arm. RESULTS: Of the 183 cases, 87 were randomised to treatment with hCG while 96 were randomised to receive a placebo. Forty-seven (25%) did not comply with the study protocol. The mean [SD] gestational age at presentation was 7 [1.33] weeks. The mean [SD] age of women in study was 27 [5] years in the placebo and 28 [5] in the hCG group. The mean body mass index (kg/m(2)) was 25 [5] in the study. The number of patients actively bleeding per vaginum at presentation was 85 (93%) in placebo group and 79 (96%) in the hCG group. The median number of hCG or placebo injections for both groups was 7. Ten women (11%) in the placebo group proceeded to have a complete miscarriage, as did 10 women (12%) in the hCG group, relative risk (RR) [95% confidence interval (CI)] of 1.1 (0.63-1.6). CONCLUSION: Our study showed no evidence of a difference in the outcome of threatened miscarriages when treated with hCG in the first trimester, this may be because our study sample size was small and follow up was suboptimal. A large, randomised, multicentre trial is still needed to establish the usefulness of hCG treatment in cases of threatened miscarriage.

Abortion, Threatened↗
PubMed2000

Effect of counselling mothers on their children's exposure to environmental tobacco smoke: randomised controlled trial.

OBJECTIVE: To test the efficacy of behavioural counselling for smoking mothers in reducing young children's exposure to environmental tobacco smoke. DESIGN: Randomised double blind controlled trial. SETTING: Low income homes in San Diego county, California. PARTICIPANTS: 108 ethnically diverse mothers who exposed their children (aged <4 years) to tobacco smoke in the home. INTERVENTION: Mothers were given seven counselling sessions over three months. MAIN OUTCOME MEASURES: Children's reported exposure to environmental tobacco smoke from mothers in the home and from all sources; children's cotinine concentrations in urine. RESULTS: Mothers' reports of children's exposure to their smoke in the home declined in the counselled group from 27.30 cigarettes/week at baseline, to 4.47 at three months, to 3.66 at 12 months and in the controls from 24.56, to 12.08, to 8.38. The differences between the groups by time were significant (P=0.002). Reported exposure to smoke from all sources showed similar declines, with significant differences between groups by time (P=0.008). At 12 months, the reported exposure in the counselled group was 41.2% that of controls for mothers' smoke (95% confidence interval 34.2% to 48.3%) and was 45.7% (38.4% to 53.0%) that of controls for all sources of smoke. Children's mean urine cotinine concentrations decreased slightly in the counselled group from 10.93 ng/ml at baseline to 10.47 ng/ml at 12 months but increased in the controls from 9.43 ng/ml to 17.47 ng/ml (differences between groups by time P=0.008). At 12 months the cotinine concentration in the counselled group was 55.6% (48.2% to 63.0%) that of controls. CONCLUSIONS: Counselling was effective in reducing children's exposure to environmental tobacco smoke. Similar counselling in medical and social services might protect millions of children from environmental tobacco smoke in their homes.

Adult↗
PubMed2001

The effects of Chinese medicinal herbs on postmenopausal vasomotor symptoms of Australian women. A randomised controlled trial.

OBJECTIVE: To evaluate the effects of a defined formula of Chinese medicinal herbs (CMH) on menopausal symptoms. DESIGN: A double-blind randomised placebo-controlled trial. METHODS: Between August 1998 and April 1999, 55 postmenopausal Australian women recruited from an urban population completed 12 weeks of intervention with either a defined formula of CMH (n = 28) or placebo (n = 27) taken twice daily as a beverage. MAIN OUTCOME MEASURES: The primary end-point was change in frequency of vasomotor events (hot flushes and night sweats). The secondary end-points were changes in score for the domains measured in the Menopause Specific Quality of Life (MENQOL) Questionnaire. RESULTS: There was a reduction in average weekly frequency of vasomotor events with CMH (-15%; 95% CI, -31% to +1%) and with placebo (-31%; 95% CI, -42% to -21%). The difference between groups favoured the use of placebo; however, this was not significant (P=0.09). Although significant reductions in scores for the various domains of the MENQOL Questionnaire were observed for both CMH and placebo, there were no significant differences between the two treatment groups for any domain. There was evidence for effect modification by previous use of natural therapies for the vasomotor, physical and sexual domains of the MENQOL Questionnaire: women with no prior use of natural therapies for their menopausal symptoms responded to therapy, whereas prior users did not. CONCLUSIONS: The defined formula of CMH was no more effective than placebo in reducing vasomotor episodes in Australian postmenopausal women, or in improving any of the four symptom domains in the MENQOL Questionnaire. Three of the MENQOL Questionnaire domains were modified by prior use of natural therapies. This finding has implications for future studies.

Aged↗
PubMed2003

Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomised controlled trial.

BACKGROUND: Tumour necrosis factor production is increased in the mucosa of patients with active ulcerative colitis. The benefits of infliximab in Crohn's disease are established. We investigated its efficacy in ulcerative colitis. METHODS: We conducted a randomised placebo controlled trial of infliximab (5 mg/kg) in the treatment of glucocorticoid resistant ulcerative colitis. Infusions were given at weeks 0 and 2. Disease activity and quality of life were recorded over eight weeks of follow up. Remission was defined as an ulcerative colitis symptom score (UCSS) of < or =2 and/or Baron score of 0 at week 6. Patients not in remission were offered open label infliximab 10 mg/kg and reviewed two weeks later. RESULTS: After two weeks, there was no statistically significant difference between the infliximab and placebo groups in the proportion of patients with a Baron score of 0 (13% (3/23) v 5% (1/19) (95% confidence interval (CI) -9% to 24%); p=0.74). After six weeks, remission (UCSS < or =2) rates were 39% (9/23) versus 30% (6/20) (95% CI -19 to 34%; p=0.76). The median improvement in UCSS was 3 for the infliximab group and 2.5 for the placebo group (p=0.82, Mann-Whitney U test). A Baron score of 0 was likely in either group (26% (6/23) v 30% (6/20) (95% CI -30% to 23%); p=0.96). Improvement in the IBDQ and EuroQol was not significantly different between the groups (p=0.22 and 0.3, respectively, Mann-Whitney U test). Twenty eligible patients were given open labelled infusions. Remission was achieved in 3/11 (27%) patients initially treated with infliximab and in 1/9 (11%) patients treated with placebo. CONCLUSION: These data do not support the use of infliximab in the management of moderately active glucocorticoid resistant ulcerative colitis.

Adult↗
PubMed2026

Post-trial 12-month follow-up of TRACE (targeted research on addictive and compulsive eating) randomised controlled trial participants: A brief report.

Few treatment interventions for addictive eating have evaluated long-term effectiveness. This post-trial follow-up study evaluates secondary changes in addictive eating symptoms and quality of life at 12-months in a sample of individuals who participated in the TRACE (Targeted Research for Addictive and Compulsive Eating) RCT. Thirty-three adults out of possible 144 (82% female), median age 53 years, randomised to either the active intervention (five telehealth sessions delivered over 3-months), passive intervention (self-guided workbook) or control group completed an online post-trial survey. Pre- and immediate post-intervention (3-months) outcomes were compared to 12-months post-trial outcomes. Positive effects reported in the short term showed a rebound effect at post-trial follow-up in &#x223c;50% of participants. The findings suggest that longer term support is needed to maintain changes in addictive eating behaviours and improve quality of life. Future research is needed to identify optimal intervention durations and support options for sustained change. Australian New Zealand Clinical Trials Registry (ACTRN12621001079831).

Humans↗
PubMed2005

Randomised controlled trial evaluating effects of morphine on plasma adrenaline/noradrenaline concentrations in newborns.

OBJECTIVES: To determine the effects of continuous morphine infusion in ventilated newborns on plasma concentrations of adrenaline (epinephrine) and noradrenaline (norepinephrine) and their relation to clinical outcome. DESIGN: Blinded, randomised, placebo controlled trial. SETTING: Level III neonatal intensive care units in two centres. PATIENTS: A total of 126 ventilated neonates (inclusion criteria: postnatal age <3 days, duration of ventilation <8 hours, indwelling arterial catheter for clinical purposes; exclusion criteria: severe asphyxia, severe intraventricular haemorrhage, major congenital anomalies, neuromuscular blockers). INTERVENTIONS: Plasma adrenaline and noradrenaline concentrations were determined in patients during blinded morphine (n = 60) and placebo (n = 66) infusion (100 microg/kg plus 10 microg/kg/h). RESULTS: Plasma concentrations at baseline (nmol/l with interquartile range in parentheses) were comparable in infants treated with morphine (adrenaline, 0.22 (0.31); noradrenaline, 2.52 (2.99)) or placebo (adrenaline, 0.29 (0.46); noradrenaline, 2.44 (3.14)). During infusion, median adrenaline concentrations were 0.12 (0.28) and 0.18 (0.35) and median noradrenaline concentrations were 2.8 (3.7) and 3.8 (4.0) for the morphine and placebo treated infants respectively. Multivariate analyses showed that noradrenaline (p = 0.029), but not adrenaline (p = 0.18), concentrations were significantly lower in the morphine group than the placebo group. Furthermore, noradrenaline concentrations were related to the length of stay in the neonatal intensive care unit. CONCLUSIONS: Continuous morphine infusion significantly decreased plasma noradrenaline concentrations in ventilated newborns compared with placebo treatment. The results of this study support the idea that routine morphine administration decreases stress responses in ventilated neonates.

Analgesics, Opioid↗
PubMed2004

Preventing pressure ulcers with the Australian Medical Sheepskin: an open-label randomised controlled trial.

OBJECTIVE: To estimate the effectiveness of a new high-performance Australian medical sheepskin (meeting Australian Standard 4480.1-1998) in preventing pressure ulcers in a general hospital population at low to moderate risk of these ulcers. DESIGN: Open-label randomised controlled clinical trial. SETTING: A large metropolitan teaching hospital in Melbourne, Victoria, in 2000. PARTICIPANTS: 441 patients aged over 18 years admitted between 12 June and 30 November 2000, with expected length of stay over 2 days and assessed as at low to moderate risk of developing pressure ulcers. INTERVENTION: Patients were randomly allocated to receive a sheepskin mattress overlay for the duration of their hospital stay (218 patients) or usual treatment, as determined by ward staff (referent group, 223 patients). MAIN OUTCOME MEASURES: Incidence rate and cumulative incidence of pressure ulcers, assessed daily throughout hospital stay. RESULTS: 58 patients developed pressure ulcers (sheepskin group, 21; referent group, 37). Cumulative incidence risk was 9.6% in the sheepskin group (95% CI, 6.1%-14.3%) versus 16.6% in the referent group (95% CI, 12.0%-22.1%). Patients in the sheepskin group developed new pressure ulcers at a rate less than half that of referent patients (rate ratio, 0.42; 95% CI, 0.26-0.67). CONCLUSIONS: The Australian Medical Sheepskin is effective in reducing the incidence of pressure ulcers in general hospital inpatients at low to moderate risk of these ulcers.

Adolescent↗
PubMed1999

Cluster randomised controlled trial of expert system based on the transtheoretical ("stages of change") model for smoking prevention and cessation in schools.

OBJECTIVES: To examine whether a year long programme based on the transtheoretical model of behaviour change, incorporating three sessions using an expert system computer program and three class lessons, could reduce the prevalence of teenage smoking. DESIGN: Cluster randomised trial comparing the intervention to a control group exposed only to health education as part of the English national curriculum. SETTING: 52 schools in the West Midlands region. PARTICIPANTS: 8352 students in year 9 (age 13-14 years) at those schools. MAIN OUTCOME MEASURES: Prevalence of teenage smoking 12 months after the start of the intervention. RESULTS: Of the 8352 students recruited, 7444 (89.1%) were followed up at 12 months. The intention to treat odds ratio for smoking in the intervention group relative to control was 1.08 (95% confidence interval 0.89 to 1.33). Sensitivity analysis for loss to follow up and adjustment for potential confounders did not alter these findings. CONCLUSIONS: The smoking prevention and cessation intervention based on the transtheoretical model, as delivered in this trial, is ineffective in schoolchildren aged 13-14.

Adolescent↗
PubMed1996

Randomised controlled trial of percutaneous transluminal angioplasty for intermittent claudication.

OBJECTIVES: To determine differences between PTA and conventional medical treatment in treadmill distance until onset of claudication, treadmill maximum walking distance, patient reported maximum walking distance, ankle brachial pressure index (ABPI), quality of life (Nottingham Health Profile, NHP) and Duplex measured extent of occlusive disease. DESIGN: Randomised controlled clinical trial. METHODS: Six hundred claudicants were screened. Fifty-one men and 11 women with intermittent claudication due to short femoral stenoses or occlusions (n = 47) and iliac stenoses (n = 15) were randomised to either PTA plus medical treatment (PTA group, n = 30) or to medical treatment alone (control group, n = 32). Medical treatment consisted of daily low dose aspirin and advice on smoking and exercise. RESULTS: At 6 month follow up: In the PTA group more patients reported no claudication (p < or = 0.05) and were asymptomatic on the treadmill (p < or = 0.01) compared to the control group. The ABPI was significantly higher in the PTA group. More of the PTA group reported lower NHP pain scores (p < or = 0.05). In the control group there were more occluded arteries (p < or = 0.001), and the stenosis velocity ratio of patient arteries was significantly higher (p < or = 0.001). CONCLUSIONS: Only 10% of claudicants had discrete lesions suitable for PTA. Treatment of these patients with PTA produces a greater short-term improvement in walking and quality of life than medical treatment alone and is associated with less progression of disease.

Angioplasty, Balloon↗
PubMed2001

A randomised controlled trial of antibiotic prophylaxis in elective caesarean delivery.

OBJECTIVE: To determine whether prophylactic antibiotic administration using cefoxitin at the time of elective caesarean section significantly reduces infectious morbidity. SETTING: A tertiary teaching hospital in a large urban city in South Africa. PARTICIPANTS: Women undergoing elective caesarean section. DESIGN: A prospective, double-blind randomised placebo-controlled trial. METHODS: Four hundred and eighty women undergoing elective caesarean section had cefoxitin or placebo administration after umbilical cord clamping. Postpartum complications including febrile morbidity, wound infection, endometritis, urinary tract infection, pneumonia and transient postpartum fever were recorded, as were the duration of hospital stay and the need for therapeutic antibiotics. RESULTS: Wound infection was the most common complication occurring in 13.3% and 12.5% of women in the placebo and cefoxitin groups, respectively. Prophylactic antibiotics did not decrease febrile morbidity, wound infection, endometritis, urinary tract infection and pneumonia. Women who received cefoxitin stayed on average a day less in hospital than those who received placebo (6.9 vs 7.8 days, risk difference 0.94 CI 1.57 - 0.31 days). Eleven women (4.6%) in the placebo group and eight (3.4%) in the cefoxitin group had microbiological evidence of wound infection. Staphylococcus aureus was the most common pathogen (43%) isolated. Similar proportions in both groups (6.3% placebo and 5.1% cefoxitin) required a course of therapeutic antibiotics. CONCLUSION: Antibiotic prophylaxis with cefoxitin in elective caesarean section did not reduce post-operative infectious morbidity in this double-blind randomised placebo controlled trial.

Adult↗
PubMed1999

Screening for ovarian cancer: a pilot randomised controlled trial.

BACKGROUND: The value of screening for ovarian cancer is uncertain. We did a pilot randomised trial to assess multimodal screening with sequential CA 125 antigen and ultrasonography. METHODS: Postmenopausal women aged 45 years or older were randomised to a control group (n=10,977) or screened group (n=10,958). Women randomised to screening were offered three annual screens that involved measurement of serum CA 125, pelvic ultrasonography if CA 125 was 30 U/mL or more, and referral for gynaecological opinion if ovarian volume was 8.8 mL or more on ultrasonography. All women were followed up to see whether they developed invasive epithelial cancers of the ovary or fallopian tube (index cancers). FINDINGS: Of 468 women in the screened group with a raised CA 125, 29 were referred for a gynaecological opinion; screening detected an index cancer in six and 23 had false-positive screening results. The positive predictive value was 20.7%. During 7-year follow-up, ten further women with index cancers were identified in the screened group and 20 in the control group. Median survival of women with index cancers in the screened group was 72.9 months and in the control group was 41.8 months (p=0.0112). The number of deaths from an index cancer did not differ significantly between the control and screened groups (18 of 10,977 vs nine of 10,958, relative risk 2.0 [95% CI 0.78-5.13]). INTERPRETATION: These results show that a multimodal approach to ovarian cancer screening in a randomised trial is feasible and justify a larger randomised trial to see whether screening affects mortality.

CA-125 Antigen↗