scholarly journals Safety and Efficacy of Misoprostol versus Oxytocin for the Prevention of Postpartum Hemorrhage

2014 ◽  
Vol 2014 ◽  
pp. 1-4 ◽  
Author(s):  
Minoo Rajaei ◽  
Samieh Karimi ◽  
Zohreh Shahboodaghi ◽  
Hamidreza Mahboobi ◽  
Tahereh Khorgoei ◽  
...  
Keyword(s):  
Postpartum Hemorrhage ◽  
Controlled Trial ◽  
Clinical Settings ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Ringer’S Solution ◽  
Oral Misoprostol ◽  
Significant Difference ◽  
Misoprostol Group ◽  
To Receive

Postpartum hemorrhage (PPH) is the commonest cause of maternal death worldwide. Studies suggest that the use of misoprostol may be beneficial in clinical settings where oxytocin is unavailable. The aim of this study was to compare the safety and efficacy of oxytocin and misoprostol when used in the prevention of PPH. In a double-blind randomized controlled trial, 400 pregnant women who had a vaginal delivery were assigned into two groups: to receive either 20 IU of oxytocin in 1000 mL Ringer’s solution and two placebo tablets or 400 mcg oral misoprostol (as two tablets) and 2 mL normal saline in 1000 mL Ringer’s solution. The quantity of blood loss was higher in the oxytocin group in comparison to the misoprostol group. There was no significant difference in the decrease in hematocrit and hemoglobin between the two groups. Although there was no significant difference in the need for transfusions between the two groups, the patients in the oxytocin group had greater need for additional oxytocin. Results from this study indicate that it may be considered as an alternative for oxytocin in low resource clinical settings. This study is registered with ClinicalTrials.govNCT01863706.

A double-blind placebo-controlled trial of perioperative prophylactic antibiotics for elective neurosurgery

1988 ◽  
Vol 69 (5) ◽  
pp. 687-691 ◽  
Author(s):  
Ross Bullock ◽  
James R. van Dellen ◽  
William Ketelbey ◽  
S. Gustav Reinach
Keyword(s):  
Controlled Trial ◽  
Prophylactic Antibiotics ◽  
Risk Of Infection ◽  
Broad Spectrum Antibiotic ◽  
Wound Sepsis ◽  
Double Blind ◽  
Content Type ◽  
Exact Test ◽  
Significant Difference ◽  
To Receive

✓ In this study, 417 patients undergoing “clean” elective neurosurgical operative procedures were randomized to receive a broad-spectrum antibiotic (piperacillin) or placebo given as three perioperative doses, each 6 hours apart. Randomization was carried out by hospital pharmacists, and the investigators remained blinded until the end of the study. Twenty cases were excluded from analysis because either an unforeseen second operation was performed or antibiotic therapy was initiated within 30 days after surgery to treat infection or the risk of infection. Twelve of the 205 patients treated with placebo developed postoperative wound sepsis, and four of the 192 piperacillin-treated patients developed wound sepsis — a statistically significant difference (p < 0.05, Fisher's exact test). Piperacillin thus appeared to reduce the incidence of neurosurgical wound infection in this study.

scholarly journals Design and rationale of randomized, double-blind trial of the efficacy and safety of pirfenidone in patients with fibrotic hypersensitivity pneumonitis

2021 ◽  
pp. 00054-2021
Author(s):  
Evans R. Fernández Pérez ◽  
James L. Crooks ◽  
Jeffrey J. Swigris ◽  
Joshua J. Solomon ◽  
Michael P. Mohning ◽  
...  
Keyword(s):  
Hypersensitivity Pneumonitis ◽  
Controlled Trial ◽  
Lung Parenchyma ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Secondary Endpoints ◽  
The Mean ◽  
Predicted Values ◽  
Study Participants ◽  
To Receive

Hypersensitivity pneumonitis (HP) is an immunologically mediated form of lung disease resulting from inhalational exposure to any of a large variety of antigens. A subgroup of patients with HP develops pulmonary fibrosis (fibrotic HP, FHP), a significant cause of morbidity and mortality. This study will evaluate the safety and efficacy of the antifibrotic pirfenidone in treating FHP.This single-center, randomized, double-blind, placebo-controlled trial is enrolling adults with FHP (ClinicalTrials.gov: NCT02958917). Study participants must have fibrotic abnormalities involving ≥5% of the lung parenchyma on high-resolution CT scan, forced vital capacity ≥40% and diffusing capacity of the lung for carbon monoxide ≥30% of predicted values. Study participants will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg·d−1 or placebo. The primary efficacy endpoint is the mean change in %FVC from baseline to week 52. A number of secondary endpoints have been chosen to evaluate the safety and efficacy in different domains.

scholarly journals Comparison of azithromycin vs doxycycline prophylaxis in leptospirosis, A randomized double blind placebo-controlled trial

2018 ◽  
Vol 12 (11) ◽  
pp. 991-995
Author(s):  
Ahmad Alikhani ◽  
Ebrahim Salehifar ◽  
Fatemeh Zameni ◽  
Alireza Rafiei ◽  
Jamshid Yazdani-charati ◽  
...  
Keyword(s):  
Paddy Field ◽  
Controlled Trial ◽  
Fisher Exact Test ◽  
Mazandaran Province ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Informed Consent Form ◽  
Significant Difference ◽  
Field Workers ◽  
To Receive

Introduction: Leptospirosis is an important zoonotic disease in paddy field with 29.5% prevalence rate in Mazandaran province and 4% to 52% mortality rate among hospitalized patients. Prevention is an important strategy for the control of this disease. This study aimed to compare the prophylactic effect of azithromycin versus doxycycline against leptospirosis in an endemic area in north of Iran. Methodology: In this randomized double-blind placebo-controlled trial, paddy field workers (n = 187) were randomized to receive azithromycin (500mg weekly), doxycycline (200 mg weekly) or placebo starting one week before exposure to paddy field, during and to four weeks after. Paddy field workers aged 18- 65 years who signed the informed consent form were assessed for signs and symptoms of leptospirosis in addition to serologic evidence of the disease 6th and 12th week. Data were analyzed with SPSS version 13 using Chi-square and Fisher exact test and ANOVA. Results: From June to September 2016, 187 participants were entered the study to receive azithromycin (n = 66), doxycycline (n = 71) or placebo (n = 50). In terms of preventing against clinical leptospirosis, there was not any significant difference between three arms, though there was statistically significant difference of seropositivity after 6 and 12 weeks in comparison to baseline among all three groups (P = 0.029) and between active treatment (eg. azithromycin and doxycycline) groups and placebo group (P = 0.01). Conclusion: Azithromycin like doxycycline decreased seropositivity without significant effect on clinical leptospirosis.

scholarly journals A Randomized Controlled Trial of Misoprostol and Oxytocin in the Management of Third Stage of Labor

1970 ◽  
pp. 14-16
Author(s):  
Rokshana Ivy ◽  
Hasmot Ara ◽  
Kulsum Haq ◽  
Farid Uddin Ahmed
Keyword(s):  
Developing Countries ◽  
Randomized Controlled Trial ◽  
Postpartum Hemorrhage ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Third Stage Of Labor ◽  
Oral Misoprostol ◽  
Third Stage ◽  
Misoprostol Group

The study was conducted to compare the effectiveness and safety of oral misoprostol with intramuscular oxytocin in the management of third stage of labor. One hundred patients were selected randomly who are expected to have vaginal delivery. Fifty patients received oral misoprostol 600 microgram and other fifty patients received oxytocin 10 IU intramuscularly after the birth of the baby. There were no significant differences between the prevalence of postpartum hemorrhage, duration of third stage of labor, additional oxytocin requirement, manual removal of placenta and blood transfusion. About the side-effects, shivering and fever were significantly higher in misoprostol group (p<0.001) and (p<0.003) respectively. But there were no significant differences in other sideeffects. Oral misoprostol can be used instead of intramuscular oxytocin in the management of third stage of labor, to prevent postpartum hemorrhage, in developing countries, especially as it is administered orally and thermo stable in tropical climate. Key words: Misoprostol; Oxytocin; Postpartum haemorrhage DOI: 10.3329/bjpp.v24i1.5732Bangladesh J Physiol Pharmacol 2008; 24(1&2) : 14-16

scholarly journals The Effects of Quetiapine on Craving and Withdrawal Symptoms in Methamphetamine Abuse: A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 10 (4) ◽  
pp. 29374.1-29374.7
Author(s):  
Najme Sadat Javdan ◽  
◽  
Amir Ghaderi ◽  
Hamid Reza Banafshe ◽  
◽  
...  
Keyword(s):  
Controlled Trial ◽  
Withdrawal Symptoms ◽  
Chi Square ◽  
Double Blind ◽  
Methamphetamine Abuse ◽  
Beneficial Effects ◽  
Amphetamine Withdrawal ◽  
Significant Difference ◽  
Chi Square Test ◽  
To Receive

Background: Patients with Methamphetamine Abuse (MA) are susceptible to many complications like craving, and withdrawal symptoms. These trials were designed to evaluate the effect of quetiapine administration on craving and withdrawal symptoms in MA abuse. Methods: This trial was conducted on 60 people with MA abuse to receive either 100 mg quetiapine (n=30), or placebo (n=30) every day for 2 months. The Desire for Drug Questionnaire (DDQ) and Amphetamine Withdrawal Questionnaire (AWQ) scores were evaluated at baseline and after 2 months’ intervention. For data analysis, t test, and the Chi-square test were applied in SPSS v. 18. Results: Quetiapine significantly decreased DDQ (P=0.002) and AWQ symptoms (P=0.001) compared to the placebo. Furthermore, there was a significant difference among groups in terms of the frequency of negative urine tests (P<0.001). Conclusion: This trial showed that administration of quetiapine supplements for 2 months in individuals with MA abuse had beneficial effects on craving and withdrawal syndrome.

scholarly journals The Effect of Viola odorata Flower Syrup on the Cough of Children With Asthma

2015 ◽  
Vol 20 (4) ◽  
pp. 287-291 ◽  
Author(s):  
Mohammad Javad Qasemzadeh ◽  
Hosein Sharifi ◽  
Mohammad Hamedanian ◽  
Mohammad Gharehbeglou ◽  
Mojtaba Heydari ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Inverse Correlation ◽  
Therapeutic Effects ◽  
Double Blind ◽  
Short Acting ◽  
Significant Difference ◽  
Children With Asthma ◽  
Basic Characteristics ◽  
To Receive ◽  
Intermittent Asthma

This study aimed to investigate the effect of violet syrup on cough alleviation in children with intermittent asthma. In a parallel, double-blind, randomized controlled trial, 182 children aged 2 to 12 years with intermittent asthma were randomly assigned 1:1 to receive violet syrup or placebo along with the common standard treatments in both groups (short-acting β-agonist). Both groups were evaluated in terms of the duration until cough suppression was achieved. No significant difference was observed in basic characteristics. The duration lasting to yield more than 50% cough reduction and 100% cough suppression was significantly less in the violet syrup group compared to placebo ( P = .001, P < .001, respectively). There was no significant difference in therapeutic effects between boys and girls. There was a significant inverse correlation between the age of children and rate of cough alleviation and suppression by violet syrup. This study showed that the adjuvant use of violet syrup with short-acting β-agonist can enhance the cough suppression in children with intermittent asthma.

scholarly journals Effects of Perioperative Rosuvastatin for Postoperative Delirium After Elderly General Anesthesia Patients: A Randomized, Double-Blind, and Placebo-Controlled Trial

2021 ◽  
Author(s):  
Xiaoqin Xu ◽  
Jingzhi Luo ◽  
Xiaoyu Li ◽  
Haiqin Tang ◽  
Weihong Lu
Keyword(s):  
Clinical Trials ◽  
General Anesthesia ◽  
Clinical Outcomes ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Care Providers ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

Abstract Background: Experimental evidence has indicated the benefits of statins for the treatment of postoperative delirium. Previously clinical trials had no definite conclusions of statins on delirium. Some clinical trials indicated statins can reduce postoperative delirium and improve outcome, while some studies showed negative results. Therefore, the present study tries to evaluate whether perioperative rosuvastatin treatment could reduce the incidence of delirium and improve clinical outcomes. Methods: This was a randomized, double-blind, and placebo-controlled trial in a single-center in Jiangsu, China. This study enrolled patients aged more than 60 years old who present selective general anesthesia operation, with informed consent. A computer-generated randomization sequence (in a 1:1 ratio) was used to randomly assign patients to receive either rosuvastatin (40 mg/day) or placebos. Participants, care providers, and investigators were all masked to group assignment. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method during the first 7 postoperative days. Analyses were performed by intention-to-treat and safety populations. Results: Between Jan 1, 2017, and Jan 1, 2020, 3512 patients were assessed. A total of 821 were randomly assigned to receive either a placebo (n=411) or rosuvastatin (n=410). The incidence of postoperative delirium was significantly lower in the rosuvastatin group (23 [5.6%] of 410 patients) than the placebo group (42 [13.5%] of 411 patients (OR=0.522, 95% CI 0.308-0.885; p<0.05). No significant difference on 30-day all-cause mortality (6.1% vs 8.7 %, OR 0.67, P=0.147, 95% CI 0.39–1.2) between two groups. Rosuvastatin can decrease the hospitalization time (13.8±2.5 vs 14.2±2.8, P=0.03) and hospitalization expenses (9.3±2.5 vs 9.8±2.9, P=0.007). No statistical significance between the two groups on abnormal liver enzymes (9.0% vs 7.1%, P=0.30, OR=1.307, 95% CI 0.787-2.169) and rhabdomyolysis (0.73% vs 0.24%, P=0.37, OR=3.020, 95% CI 0.31-29.2. Conclusion: The current study suggests that perioperative rosuvastatin treatment can reduce the incidence of delirium after elective general anesthesia operation. However, no evidence was found that rosuvastatin can improve clinical outcomes. The therapy was safe. Further investigation is necessary to fully understand the potential usefulness of dexmedetomidine in older patients. Trial registration: chictr.org.cn, ChiCTR-IPR-17011984(Registered date: 13/07/2017). The manuscript adheres to CONSORT guidelines.

scholarly journals Misoprostol Versus Oxytocin in the Active Management of the Third Stage of Labour

1970 ◽  
Vol 25 (2) ◽  
pp. 73-76 ◽  
Author(s):  
Nilufar Sultana ◽  
Mahmuda Khatun
Keyword(s):  
Side Effects ◽  
Post Partum ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Active Management ◽  
Oral Misoprostol ◽  
Significant Difference ◽  
Misoprostol Group ◽  
Post Partum Haemorrhage ◽  
Randomised Controlled

Objective: A randomised controlled trial was performed in Sir Solimullah Medical College Mitford Hospital, a tertiary hospital in Dhaka City for one year to compare oral misoprostol with intramascular oxytocin in the prevention of post partum haemorrhage (PPH). Method: A total of 400 women were randomised to received either 400mg misoprostol orally or 10 I.U oxytocin intramascularly. The incidence of post partum haemorrhage and side effects were examined. Result: The demographic and labour characteristic were comparable. PPH occured in 3.80% of women given misoprostol and in 2.63% of those given oxytocin (P>0.50). Measured blood loss of more than 1000 ml occured 2.38% of the misoprostol group compared with 1.58% in the oxytocin group (P>0.50). There was no significant difference in the need for additional oxytocin drugs or blood transfusion in women of both groups. Significant side effect of misoprostol were shivering (P<0.01). Conclusion: Oral misoprostol is as effective as intramascular oxytocin in the prevention of PPH. Shivering and transient pyrexia were special side effects of misoprostol. Misoprostol has potential in reducing the high incidence of PPH in developing countries. (J Bangladesh Coll Phys Surg 2007; 25 : 73-76)

scholarly journals Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): study protocol for a randomized controlled trial

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Kaibin Huang ◽  
Zhong Ji ◽  
Yongming Wu ◽  
Yunqiang Huang ◽  
Guangning Li ◽  
...  
Keyword(s):  
Promising Result ◽  
Controlled Trial ◽  
Anterior Circulation ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Target Time ◽  
Number Of Patients ◽  
Acute Cerebral Ischemia ◽  
To Receive

Abstract Background Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability. Glibenclamide (US adopted name, glyburide), a long-acting sulfonylurea, shows promising result in treating AIS from both preclinical and clinical studies. This study investigates the safety and efficacy of glibenclamide combined with rtPA in treating AIS patients. Methods This is a prospective, randomized, double-blind, placebo-controlled, multicenter trial with an estimated sample size of 306 cases, starting in January 2018. Patients aged 18 to 74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4 to 25 points and treated with intravenous rtPA within the first 4.5 h of their clinical onsets, are eligible for participation in this study. The target time from the onset of symptoms to receive the study drug is of 10 h. Subjects are randomized 1: 1 to receive glibenclamide or placebo with a loading dose of 1.25 mg, followed by 0.625 mg every 8 h for total 5 days. The primary efficacy endpoint is 90-day good outcome, measured as modified Rankin Scale of 0 to 2. Safety outcomes are all-cause 30-day mortality and early neurological deterioration, with a focus on cardiac- and glucose-related serious adverse events. Discussion This study will provide valuable information about the safety and efficacy of oral glibenclamide for AIS patients treated with rtPA. This would bring benefits to a large number of patients if the agent is proved to be effective. Trial registration The trial was registered on September 14th 2017 at www.clinicaltrials.gov having identifier NCT03284463. Registration was performed before recruitment was initiated.

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