scholarly journals Prophylactic Administration of Per Rectal Misoprostol vs Intramuscular Injection of Oxytocin in Third-stage of Labour for Prevention of Postpartum Haemorrhage: A Randomised Controlled Trial

2021 ◽  
Author(s):  
Sougata Kumar Burman ◽  
Ritwik Samanta ◽  
Kumari Kanak Lata ◽  
Jayeeta Mukherjee ◽  
Tapan Kumar Dey
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Effects ◽  
Blood Loss ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Effective Control ◽  
Control Group ◽  
Third Stage ◽  
The Mean ◽  
Randomised Controlled

Introduction: In India, the routine Active Management of Third- Stage of Labour (AMTSL) with conventional intramuscular oxytocin, at the rural, resource-constrained areas, is often compromised due to lack of trained healthcare personnel and proper maintenance of cold chain system, causing maternal mortality and morbidity from Postpartum Haemorrhage (PPH). In these scenarios, tablet misoprostol, can be efficacious and convenient alternative. Aim: To evaluate efficacy and safety of misoprostol administered per rectum with respect to intramuscular oxytocin for effective control of PPH in a Randomised Controlled Trial (RCT). Materials and Methods: In this RCT, conducted in Sambhunath Pandit Hospital, kolkata, West Bengal, India from September 2015 to August 2016, total 80 eligible pregnant mothers in normal labour with prior consent and fulfilled criteria, were allocated to two separated groups (n=40) by computer generated randomisation table. Control group received 10 IU injection oxytocin and case group received 600 μg misoprostol tablet per rectally within one minute of cord clamping and cutting. The primary outcome measures were mean third- stage and mean postpartum blood loss up to eight hours after delivery. Secondary outcome variables were Mean Arterial Pressure (MAP) after eight hours postdelivery, haemoglobin and haematocrit after 24 hours of delivery and reported side effects. Data was entered into a Microsoft excel spreadsheet and statistical analysis was done by Statistical Package for the Social Sciences (SPSS) version 20.0.1 and Graph Pad Prism version 5.0. Results: Total sample size was 80 equally divided into two groups, with a mean age of 23.20±3.1558 years and 23.7750±3.8927 years in case and control group respectively. The mean third-stage blood loss (332.4105±72.6632 mL versus {vs} 329.0088±59.4503 mL, p=0.8193) and mean total blood loss (426.5575±80.0215 mL vs 424.8783±61.5808 mL, p=0.9165) were statistically indifferent between misoprostol and oxytocin groups by two-sample t-tests. The mean for eight hours postpartum MAP (p=0.0894), 24 hours postpartum haemoglobin (p=0.4534) and haematocrit (p=0.1325) were statistically insignificant between the two groups by two- sample t-tests. Incidence of adverse effects like shivering, diarrhoea, compared by Pearson’s Chi-square test, were found to be more but non significant in misoprostol group. Conclusion: This study concludes that per-rectal misoprostol is equally effective as intramuscular oxytocin to control PPH without significant adverse effects.

scholarly journals Effect of a financial incentive (shopping point) on increasing the number of daily walking steps among community-dwelling adults in Japan: a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037303
Author(s):  
Fumiya Tanji ◽  
Yasutake Tomata ◽  
Saho Abe ◽  
Sanae Matsuyama ◽  
Yumika Kotaki ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Intervention Period ◽  
The Mean ◽  
Randomised Controlled

ObjectiveThe aim of this study was to investigate the effect of a financial incentive on the number of daily walking steps among community-dwelling adults in Japan.Study designTwo-arm, parallel-group randomised controlled trial.Setting/participantsWe recruited physically inactive community-dwelling adults from Sendai city, Japan. Eligible participants were randomly allocated to an intervention or a wait list control group. Pedometers were used to assess the mean number of daily steps in three periods: baseline (weeks 1–3), intervention (weeks 4–6) and follow-up (weeks 7–9).InterventionThe intervention group was offered a financial incentive (shopping points) to meet the target number of increased daily steps in the intervention period.Main outcome measuresThe primary outcome was an increase in the mean number of daily steps in the intervention and follow-up periods compared with baseline.ResultsSeventy-two participants (69.4% women; mean age, 61.2±16.2 years; mean number of daily steps at baseline, 6364±2804) were randomised to the intervention (n=36) and control groups (n=36). During the intervention period, the increase in mean daily steps was significantly higher in the intervention group (1650, 95% CI=1182 to 2119) than in the control group (514, 95% CI=136 to 891; p<0.001). However, the difference between groups was not significant at follow-up after the incentives were removed (p=0.311). In addition, compared with controls, a significantly higher proportion of participants in the intervention group showed an increase in mean daily steps of ≥1000 (69.4% vs 30.6%, respectively; OR=5.17, 95% CI=1.89 to 14.08). There were no adverse effects from the intervention.ConclusionsThe present results suggest that financial incentives are effective in promoting short-term increases in physical activity.Trial registration numberUMIN000033276.

scholarly journals Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016590 ◽  
Author(s):  
Alexandre Dumont ◽  
Cécile Bodin ◽  
Benjamin Hounkpatin ◽  
Thomas Popowski ◽  
Mamadou Traoré ◽  
...  
Keyword(s):  
Relative Risk ◽  
Randomised Controlled Trial ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Case Fatality ◽  
Control Group ◽  
Total Blood ◽  
Balloon Tamponade ◽  
Uterine Balloon Tamponade ◽  
Randomised Controlled

ObjectiveTo assess the effectiveness of low-cost uterine tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage (PPH) in low-resource settings.DesignRandomised controlled trial.SettingSeven healthcare facilities in Cotonou, Benin and Bamako, Mali.PopulationWomen delivering vaginally who had clinically diagnosed PPH that was suspected to be due to uterine atony, who were unresponsive to oxytocin and who needed additional uterotonics.MethodsWomen were randomly assigned to receive uterine balloon tamponade with a condom-catheter device or no tamponade; both groups were also given intrarectal or sublingual misoprostol.Main outcome measureProportion of women with invasive surgery or who died before hospital discharge.ResultsThe proportion of primary composite outcome did not differ significantly between the tamponade arm (16%; 9/57) and the standard second line treatment arm (7%; 4/59): relative risk 2.33 (95% CI 0.76 to 7.14, p=0.238). A significantly increased proportion of women with tamponade and misoprostol versus misoprostol alone had total blood loss more than 1000 mL: relative risk 1.52 (95% CI 1.15 to 2.00, p=0.01). Case fatality rate was higher in the tamponade group (10%; 6/57) than in the control group (2%; 1/59) (p=0.059).Trial registration numberISRCT Registry Number 01202389; Post-results.

scholarly journals Effects of an actual insulin injection demonstration on insulin acceptance among patients with T2DM: a pragmatic randomised controlled trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Atthayaporn Choomai ◽  
Apichai Wattanapisit ◽  
Orathai Tiangtam
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Intervention Group ◽  
Insulin Injection ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial ◽  
Hba1c Levels

AbstractIntroduction. Insulin injection refusal is a challenge when initiating insulin therapy. This study aimed to investigate the effects of an actual insulin injection demonstration on insulin acceptance in patients with type 2 diabetes mellitus (T2DM).Methods. A pragmatic randomised controlled trial (RCT) was conducted. The participants were patients with T2DM aged 18–65 years old. The control group (CG) received an educational programme regarding T2DM. The intervention group (IG) received the educational programme and actual insulin injection demonstration (a physician-led sample insulin injection using an insulin pen). The main outcome was immediate insulin acceptance. Insulin adherence, glycated haemoglobin (HbA1c), and adverse effects of insulin were evaluated at three months after the intervention.Results. Forty-nine participants with T2DM were allocated to the IG (n=24) and the CG (n=25). The immediate insulin acceptance was significantly higher in the IG (79.17%, n=19) than the CG (24.00%, n=6; p---lt---0.05; RR 3.30, 95%CI 1.59 to 6.82). At the three-month follow-up, the insulin adherence was significantly different between the two groups (IG: 75.00%, n=18 vs CG: 20.00%, n=5; p---lt---0.05; RR 3.75, 95%CI 1.66 to 8.49). Adverse effects of insulin, HbA1c levels, and changes in HbA1c levels between the IG and CG were not different.Conclusion. The physician-led actual insulin injection demonstration is effective for increasing insulin acceptance among participants with T2DM.

scholarly journals A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ahmad Farouk Musa ◽  
Jeswant Dillon ◽  
Mohamed Ezani Md Taib ◽  
Alwi Mohamed Yunus ◽  
Abdul Rais Sanusi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Randomised Controlled Trial ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Control Group ◽  
Inflammatory Agent ◽  
Significant Difference ◽  
The Mean ◽  
Anti Inflammatory ◽  
Randomised Controlled

Abstract Introduction Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. Aims The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay. Methods This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life. Results Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045). Conclusion A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

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