scholarly journals A Randomised Controlled Trial Comparing Intravaginal Misoprostol and Intracervical Dinoprostone in Pre Induction Cervical Ripening

2013 ◽  
Vol 1 (03) ◽  
pp. 45-54
Author(s):  
B. H. Radhika ◽  
S. Soundara Raghavan
Keyword(s):  
Controlled Trial ◽  
Mode Of Delivery ◽  
Primary Outcome Measure ◽  
Cervical Ripening ◽  
Secondary Outcome ◽  
Bishop Score ◽  
Intervention Delivery ◽  
Misoprostol Group ◽  
Randomised Controlled ◽  
Mean Cost

Objective: To compare the efficacy and safety of intravaginal misoprostol with intracervical dinoprostone for preinduction cervical ripening. Material andMethods: It was a randomized controlled trial conducted at department of obstetrics and gynecology, JIPMER, Puducherry. Three hundred women with Bishop score of 6, were assigned randomly to receive either intravaginal misoprostol 25 μg every four hours for four doses, and intracervical dinoprostone gel 0.5 mg every eight hours for two doses. (one hundred women in each group). Oxytocin was initiated as per standardized protocol, if the cervix was favourable. If the cervical ripening was unsuccessful (Bishop score 6) after the maximum doses of drugs in both the groups, then further treatment was individualized. Efficacy and cost of the drugs were compared in both groups. Results: Primary outcome measure was change in Bishop score. Mean Bishop score change at the end of 16 hours was significantly higher in the misoprostol group, (2.57±0.59) compared to dinoprostone group (2.17±0.10, p=0.016). This finding was inspite of the fact that the dinoprostone group had higher Bishop score prior to the ripening.(3.55±0.56 vs 3.28±0.77, p=0.006). Secondary outcome measures such as mean intervention-delivery interval, oxytocin requirement, mode of delivery, maternal and neonatal outcomes were similar in both the groups. Overall mean cost of ripening agent per patient was significantly less in the misoprostol group, (22.56±93.16 rupees) compared to dinoprostone group (493.89±173.99 rupees, p0.0001).Conclusion: Low dose misoprostol is as effective as dinoprostone in cervical ripening and demonstrates similar fetal and maternal safety profile.

scholarly journals Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

2018 ◽  
Vol 213 (1) ◽  
pp. 404-411 ◽  
Author(s):  
Ulrika Karlsson Stigsdotter ◽  
Sus Sola Corazon ◽  
Ulrik Sidenius ◽  
Patrik Karlsson Nyed ◽  
Helmer Bøving Larsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Increasing Demand ◽  
Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

scholarly journals A randomised controlled trial of preinduction cervical ripening-dinoprostone versus foleys catheter

2017 ◽  
Vol 6 (6) ◽  
pp. 2387
Author(s):  
Mumtaj M. ◽  
Harilakshmi M.
Keyword(s):  
Controlled Trial ◽  
Mode Of Delivery ◽  
Cost Effective ◽  
Fetal Outcome ◽  
Cervical Ripening ◽  
Maternal Complications ◽  
Number Of Patients ◽  
Significant Difference ◽  
Failed Induction ◽  
Randomised Controlled

Background: Cervical ripening before induction of labour in women with unfavourable cervix is essential to shorten the induction to delivery interval and avoid unnecessary interventions.Methods: The study was carried out at Raja Sir Ramasamy Mudaliar hospital, Chennai during the period August 2012 to July 2013. 200 antenatal women were recruited and randomly allocated to Foleys and prostaglandin E2 gel group for induction. The change in bishops score, induction to delivery interval, mode of delivery, vaginal delivery within 24 hours, maternal complications, fetal outcome between both groups were compared.Results: The commonest indication for induction in both groups was postdated pregnancy followed by oligohydramnios in Foleys group and preeclampsia in PGE2 group. Foleys catheter induction improves bishops score better compared to PGE2 gel whereas PGE2 gel causes a significant reduction in the mean induction to delivery interval between the two groups. However, there was no significant difference between mean caesarean deliveries between the two groups. In both Foleys and the PGE2 group, failed induction was the commonest indication for caesarean section. The number of patients delivering vaginally within 24 hrs was similar between the two groups.Conclusions: Though prostaglandins are a better method of induction, this study shows that Foleys induction has reduced side effects and is also cost effective, making it a superior method for cervical ripening.

scholarly journals SAFE, a new therapeutic intervention for families of children with autism: a randomised controlled feasibility trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038411
Author(s):  
Rebecca McKenzie ◽  
Rudi Dallos ◽  
Jacqui Stedmon ◽  
Helen Hancocks ◽  
Patricia Jane Vickery ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Controlled Trial ◽  
Children With Autism ◽  
Primary Outcome Measure ◽  
Positive Change ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Recommended Care ◽  
Related Family ◽  
Randomised Controlled

ObjectivesTo establish the feasibility of a definitive randomised controlled trial of Systemic Autism-related Family Enabling (SAFE), an intervention for families of children with autism.DesignA randomised, controlled, multicentred feasibility study.SettingParticipants were identified from three National Health Service (NHS) diagnosing centres in Plymouth and Cornwall and a community pathway.Participants34 families of a child with a diagnosis of autism severity level 1 or 2 between 3 and 16 years. Four families were lost to follow-up.InterventionsSAFE is a manualised five-session family therapy-based intervention delivered over 16 weeks and designed for families of children with autism. SAFE involves families attending five 3-hour sessions led by systemic practitioners.Primary and secondary outcome measuresThe proposed primary outcome measure was the Systemic CORE 15 (SCORE-15). Proposed secondary outcome measures: Patient Health Questionnaire-Somatic Anxiety Depressive Symptoms, the Coding of Attachment-Related Parenting for use with children with Autism, the Child Behaviour Checklist (CBCL), the Reflective Functioning Questionnaire (RFQ) and the Caregiving Helplessness Questionnaire. Outcome measures were collected at baseline and 24 weeks post randomisation.ResultsAll primary caregivers retained in the study completed the SCORE-15 at both time points. 34 of the target of 36 families were recruited and 88% of families were retained. Training for therapists was effective. Feedback revealed willingness to undergo randomisation. There was 100% attendance at appropriate sessions for core family members. The SCORE-15 showed reduction in scores for families receiving SAFE compared with controls suggesting positive change. Qualitative data also revealed that families found the study acceptable and families receiving SAFE experienced positive change. Feedback indicated that the SCORE-15 should be retained as a primary measure in a future trial, but secondary measures should be reduced.ConclusionsThis study indicates that a larger trial of SAFE is feasible. Findings suggest that SAFE can address current gaps in recommended care, can be confidently delivered by NHS staff and has potential as a beneficial treatment.Trial registration numbersISCTRN83964946 and IRAS213527.

scholarly journals The effect of ‘Zesy002’ kiwifruit (Actinidia chinensisvar.chinensis) on gut health function: a randomised cross-over clinical trial

2019 ◽  
Vol 8 ◽  
Author(s):  
Sarah L. Eady ◽  
Alison J. Wallace ◽  
Christine A. Butts ◽  
Duncan Hedderley ◽  
Lynley Drummond ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Functional Gastrointestinal Disorders ◽  
Primary Outcome Measure ◽  
Positive Control ◽  
Secondary Outcome ◽  
Bowel Habit ◽  
Gut Health ◽  
Daily Consumption ◽  
Gastrointestinal Discomfort ◽  
Randomised Controlled

AbstractFunctional gastrointestinal disorders including constipation affect up to 14 % of the world's population. Treatment is difficult and challenging resulting in a need for alternative safe and effective therapies. The present study investigated whether daily consumption of three gold-fleshed kiwifruit could alleviate constipation and improve gastrointestinal discomfort in mildly constipated individuals with and without pain. A total of thirty-two participants were enrolled in a 16-week randomised, single-blind, crossover study. Participants received either three ‘Zesy002’ kiwifruit or 14·75 g Metamucil®(5 g dietary fibre/d (a positive control)) for 4 weeks each with a 4-week washout between treatments. A 2-week washout period was included at the beginning and end of the study. Daily bowel habit diaries were kept throughout the study. The primary outcome measure was differences in the number of complete spontaneous bowel movements (CSBM). Secondary outcome measures were bowel movement frequency and stool form as well as digestive symptoms and comfort. The number of CSBM per week was significantly greater during daily consumption of three kiwifruit compared with the baseline (6·3v.3·3;P< 0·05) and the Metamucil®treatment (6·3v.4·5;P< 0·05). Stool consistency was also improved, with kiwifruit producing softer stools and less straining (P< 0·05). Gastrointestinal discomfort was also improved compared with baseline for abdominal pain, constipation and indigestion (P< 0·05) during the kiwifruit intervention and constipation during the Metamucil®intervention (P< 0·05). This randomised controlled trial demonstrates that daily consumption of three gold-fleshed kiwifruit is associated with a significant increase of two CSBM per week and reduction in gastrointestinal discomfort in mildly constipated adults.

scholarly journals Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017912 ◽  
Author(s):  
Yiyi Cai ◽  
Claire Shuiqing Zhang ◽  
Wenwei Ouyang ◽  
Jianmin Li ◽  
Wenheng Nong ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Ethics Committees ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Main Trial ◽  
Parallel Group ◽  
Registration Number ◽  
Randomised Controlled

IntroductionSpasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC).Methods and analysisThis study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored.Ethics and disseminationEthics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences.Trial registration numberChiCTR-IOR-16010283; Pre-results.

scholarly journals Early use of donepezil against psychosis and cognitive decline in Parkinson’s disease: a randomised controlled trial for 2 years

2018 ◽  
Vol 89 (12) ◽  
pp. 1332-1340 ◽  
Author(s):  
Hideyuki Sawada ◽  
Tomoko Oeda ◽  
Masayuki Kohsaka ◽  
Atsushi Umemura ◽  
Satoshi Tomita ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Subgroup Analysis ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Auditory Memory ◽  
Secondary Outcome ◽  
Beneficial Effects ◽  
Randomised Controlled ◽  
Apolipoprotein Ε4

ObjectivesBrain acetylcholine is decreased even in patients with cognitively preserved Parkinson’s disease (PD). We investigated whether early and long-term use of donepezil prevents psychosis in non-demented PD patients.MethodsA double-blinded, placebo-controlled trial was conducted. A total of 145 non-demented PD patients were randomly assigned to receive 5 mg/day donepezil (n=72) or placebo (n=73) for 96 weeks. Medications for PD were not restricted, but antipsychotic drugs were not permitted throughout the study. The primary outcome measure was survival time to psychosis that was predefined by Parkinson’s Psychosis Questionnaire (PPQ) B score ≥2 or C score ≥2. Secondary outcome measures included psychosis developing within 48 weeks, total PPQ score, Mini-Mental State Examination (MMSE), Wechsler Memory Scale (WMS) and subgroup analysis by apolipoprotein ε4 genotyping.ResultsKaplan-Meier curves for psychosis development were very similar between the two groups, and the Cox proportional hazard model revealed an adjusted HR of 0.87 (95%CI 0.48 to 1.60). The changes in MMSE and WMS-1 (auditory memory) were significantly better with donepezil than in placebo. In the subgroup analysis, donepezil provided an HR of 0.31 (0.11–0.86) against psychosis in 48 weeks for apolipoprotein ε4 non-carriers.ConclusionsAlthough donepezil provided beneficial effects on PPQ, MMSE and auditory WMS score changes in 2 years, it had no prophylactic effect on development of psychosis in PD. Apolipoprotein ε4 may suppress the antipsychotic effect of donepezil.Trial registration numberUMIN000005403.

scholarly journals Metformin reduces 12-month change in body weight among people newly commenced on clozapine: a retrospective naturalistic cohort study

2021 ◽  
Vol 11 ◽  
pp. 204512532110006
Author(s):  
Jessica Spokes ◽  
Samantha Hollingworth ◽  
Karl Winckel ◽  
Steve Kisely ◽  
Andrea Baker ◽  
...  
Keyword(s):  
Cohort Study ◽  
Weight Gain ◽  
Tobacco Smoking ◽  
Digital Health ◽  
Controlled Trial ◽  
Bodyweight Gain ◽  
Metabolic Effects ◽  
Secondary Outcome ◽  
Standard Clinical Practice ◽  
Randomised Controlled

Background: People with schizophrenia have a 15–20-year reduction in life expectancy, driven in part by the metabolic effects of antipsychotics. Clozapine is associated with the highest rates of weight gain. As clozapine remains the most effective antipsychotic for treatment-resistant schizophrenia (TRS), identifying treatments to ameliorate clozapine-induced weight gain (CIWG) is urgently needed to reduce this morality gap. Methods: We retrospectively analysed digital health records of patients with TRS aged 18–65 newly initiated on clozapine at four tertiary hospitals in south-east Queensland from 1 March 2017 to 30 June 2019. Our primary outcome was the effect of metformin on change in percentage bodyweight at 12 months after clozapine initiation, with secondary outcome being proportion with >5% or >7% bodyweight change. We also explored impact on bodyweight change of other variables including sex, tobacco smoking, type 2 diabetes (T2DM), age, clozapine level and dose and clozapine/norclozapine ratio. Results: Among 90 patients initiated on clozapine, metformin use ( n = 48) was associated with a smaller increase in percentage bodyweight (1.32% versus 5.95%, p = 0.031), lower rates of >7% gain in bodyweight (37.8% versus 63.0%, p = 0.025) but not >5% gain in bodyweight. Age below the median (32.0 years) was associated with greater bodyweight gain (5.55% versus 1.22%, p = 0.046). Sex, tobacco smoking, T2DM, clozapine dose and level and clozapine/norclozapine ratio were not associated with differences in change in bodyweight. Conclusion: In this small retrospective cohort study, use of metformin within 12-months of clozapine initiation was associated with a statistically and clinically significant reduction in CIWG. Although there is increasing evidence for the role of metformin to ameliorate bodyweight gain at time of clozapine initiation, our findings need replication and testing in a randomised controlled trial before recommending metformin co-commencement with clozapine as standard clinical practice.

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042365
Author(s):  
Jessica Leight ◽  
Negussie Deyessa ◽  
Vandana Sharma
Keyword(s):  
Intimate Partner Violence ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Partner Violence ◽  
Controlled Trial ◽  
Intimate Partner ◽  
Community Level ◽  
Secondary Outcome ◽  
Randomised Controlled ◽  
The Cost

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)

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