scholarly journals The Effect of Intravenous Tranexamic Acid on Hemoglobin and Hematocrit Levels After Cesarean Delivery: a Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Esmat Jafarbegloo ◽  
Faride Faridnyia ◽  
Atefeh sadat mohammad hoseini nejad
Keyword(s):  
Clinical Trial ◽  
Cesarean Section ◽  
Tranexamic Acid ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Hematocrit Level ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Novel Approach ◽  
Significant Difference

Abstract Background: During a cesarean section, the mother loses a lot of blood. This bleeding can cause a drop in hemoglobin and hematocrit. Tranexamic acid, an anti-fibrinolytic agent, is a novel approach in an attempt to prevent this dreadful complication. This study aims to explore the effect of intravenous tranexamic acid on hemoglobin and hematocrit level after cesarean section(CS) in women who were low risk in postpartum hemorrhage.Methods: This prospective randomised placebo-controlled clinical trial was carried out on 50 pregnant women referred to Izadi hospital, Qom, Iran, 2017. women were divided into two groups of 25 cases using block randomization. The study group, 25 women, received tranexamic acid 10 minutes before CS whereas the control group, 25 women received distilled water. Hemoglobin and hematocrit levels were measured before and 12-24 hours after delivery. Results: There was no significant difference in pre-operative and 12-24 h post-operative hemoglobin and hematocrit levels between the two groups(p>0.05). Conclusions: Pre-operative prescription of 1gr tranexamic acid was not associated with improvement of post-operative hemoglobin and hematocrit.Trial registration: IRCT20091010002558N7.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals The Effect of Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial

2015 ◽  
Vol 4 (1) ◽  
pp. 26-32
Author(s):  
Sara Azima ◽  
Hajar Rajaei Bakhshayesh ◽  
Keramatollah Abbasnia ◽  
Maasumeh Kaviani ◽  
Mehrab Sayadi
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pharmacological Method

Background: Primary dysmenorrhea is the most common cyclic pelvic pain and is also the most common gynecological problem worldwide and affects quality of life. The present study aimed to investigate the effect of isometric exercises on intensity and duration of pain and level of anxiety in the students with primary dysmenorrhea.Materials and Methods: In this randomized controlled clinical trial, 68 students living in dormitories of Shiraz University with primary dysmenorrhea  were randomly assigned to isometric exercises and control groups. The intervention group performed isometric exercises since the third day of the menstrual cycle for 8 weeks. Pain intensity was measured using Visual Analog Scale (VAS). In addition, the anxiety level was assessed using Spielberger questionnaire. The data were analyzed using independent t-test, repeated measures ANOVA, and Bonferroni Post hoc test at the end of the second and third months of the study. Besides, P<0.05 was considered as statistically significant.Results: Pain intensity and duration of pain was significantly reduced in exercises group (p<0.001). However, no significant difference was found between the two groups concerning the mean anxiety levels.Conclusion: Primary dysmenorrhea is a common complaint among young women. Isometric exercises seem to be an easy, non-pharmacological method for reducing primary dysmenorrheal.

scholarly journals A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique

2021 ◽  
Author(s):  
Elisabeth Maria Balint ◽  
Beate Grüner ◽  
Sophia Haase ◽  
Mandakini Kaw-Geppert ◽  
Julian Thayer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Interleukin 6 ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Single Center ◽  
Paced Breathing ◽  
Randomized Controlled ◽  
Lr Test ◽  
Practice Time

AbstractImportanceVagus nerve stimulation via slow-paced breathing could serve as adjuvant therapeutic approach to reduce excessive inflammation in coronavirus disease 2019 (COVID-19) pneumonia.ObjectiveDoes a slow-paced breathing technique increasing vagal activity reduce Interleukin-6 (IL-6) in patients hospitalized with moderate COVID-19 pneumonia compared to standard care?DesignSingle-center randomized controlled clinical trial with enrolment from February 23rd 2021 through June 17th 2021 and follow-up until July 22nd 2021.SettingWard for infectious diseases and temporary COVID-19 ward, Ulm University Hospital, GermanyParticipantsConsecutive sample of patients hospitalized with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (primary diagnosis). Of 131 patients screened, 48 patients were randomized and 46 patients analyzed (N=23 per group).InterventionsSlow-paced 20-minute breathing exercise three times a day with six breaths per minute (inhale-to-exhale ratio 4:6).Main outcomes and measuresDifferences between intervention and control group in IL-6 calculated using multilevel mixed-effect linear regression models with random slope including the covariates relevant comorbidities, COVID-19 medication, and age.ResultsMean age 57 years±13 years, N= 28 (60%) male, N=30 (65%) with relevant comorbidities. The model including group by time interaction revealed a significantly lower trajectory of IL-6 in the intervention group compared to the control group (effect size Cohens f2=0.11, LR-test p=.040) in the intention-to-treat sample, confirmed by treatment-per-protocol analysis (f2=0.15, LR-test p=.022).Exploratory analysis using the median split of practice time to predict IL-6 of the next morning indicated a dose-response relationship with beneficial effects of practice time above 45 minutes a day.Three patients in each group were admitted at ICU, one died. Oxygen saturation increased during slow-paced breathing (from 95.1%±2.1% to 95.4%±1.6%, p=0.006).Conclusion and relevancePatients practicing slow-paced breathing had significantly lower IL-6 values than controls without relevant side effects. Further trials should evaluate clinical outcomes as well as an earlier start of the intervention, i.e., at symptom onset. This would offer an access to a therapy option not only for high-income, but also for low- and middle-income countries.Trial registrationGerman register of clinical trials (ID: DRKS00023971) https://www.drks.de, Universal Trial Number (UTN) U1111-1263-8658;Key pointsQuestionCan slow-paced breathing reduce Interleukin-6 (IL-6) in hospitalized patients with moderate coronavirus disease 2019 (COVID-19) pneumonia?FindingsSingle-center randomized controlled clinical trial including 46 patients hospitalized with moderate COVID-19 pneumonia. Compared to controls, IL-6 values were significantly lower (small-to-medium effect sizes) in patients who were instructed to practice six breaths per minute for 20 minutes three times a day. More minutes of slow-paced breathing were significantly correlated with lower IL-6 values the next morning.MeaningSlow-paced breathing could be a safe and feasible adjuvant therapeutic approach in moderate COVID-19 pneumonia.

scholarly journals Effect of Physical Therapy on Bone Remodelling in Preterm Infants. A Multicenter Randomized Controlled Clinical Trial

2022 ◽  
Author(s):  
Galaad Torró-Ferrero ◽  
Francisco Javier Fernández-Rego ◽  
Rosario Jiménez-Liria ◽  
Juan Jose Agüera-Arenas ◽  
Jessica Piñero-Peñalver ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Bone Formation ◽  
Preterm Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Bone Modeling ◽  
Randomized Controlled Clinical Trial ◽  
Bone Biomarkers ◽  
Randomized Controlled

Abstract Background: Preterm infants have a low level of bone mineralization compared to those born at term, since 80% of calcium incorporation occurs at the end of pregnancy. The purpose of the present study was to investigate the effect of reflex locomotion therapy on bone modeling and growth in preterm infants and to compare its effect with those of other Physiotherapy modalities.Methods: A multicentre randomized controlled clinical trial was conducted (02/2016 – 07/2020). 106 preterm infants born at the Virgen de la Arrixaca University Clinical Hospital, the General University Hospital of Elche and the Torrecárdenas Hospital in Almería, between 29 and 34 weeks with hemodynamic stability, complete enteral nutrition and without any metabolic, congenital, genetic, neurological or respiratory disorders were evaluated for inclusion. Infants were randomly assigned to three groups: one group received reflex locomotion therapy (EGrlt); another group received passive mobilizations with gentle joint compression (EGpmc); and the control group received massage (CG). All treatments were carried out in the neonatal units lasting one month. The main outcome measure was bone formation and resorption measured with bone biomarkers. A mixed ANOVA was used to compare the results of bone biomarkers, and anthropometric measurements. Results: Infants were randomized to EGrlt (n = 38), EGpmc (n = 32), and CG (n = 36). All groups were similar in terms of gender (p = 0.891 female 47.2%), gestational age (M = 30.753, SD = 1.878, p = 0.39) and birth weight (M = 1413.45, SD = 347.36, p = 0.157). At the end of the study, significant differences were found between the groups in their interaction in bone formation, measured with osteocalcin [F (2,35) = 4.92, p = 0.013, ηp2 = 0.043], in benefit of the EGrlt. Conclusions: Reflex locomotion therapy has been effective in improving bone formation, more so than other Physiotherapy modalities. Therefore, reflex locomotion therapy could be considered one of the most effective physiotherapeutic modalities for the prevention and treatment of osteopenia of prematurity Trial registrstion: Trial retrospectively registered at ClinicalTrials.gov. First posted on 22/04/2020. Registration number: NCT04356807. URL: https://clinicaltrials.gov/ct2/show/NCT04356807?cond=Physical+Therapy+to+Prevent+Osteopenia+in+Preterm+Infants&draw=2&rank=1

scholarly journals Randomized Controlled Clinical Trial of Nanostructured Carbonated Hydroxyapatite for Alveolar Bone Repair

Materials ◽  
2019 ◽  
Vol 12 (22) ◽  
pp. 3645 ◽  
Author(s):  
Rodrigo F. B. Resende ◽  
Suelen C. Sartoretto ◽  
Marcelo J. Uzeda ◽  
Adriana T. N. N. Alves ◽  
José A. Calasans-Maia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bone Repair ◽  
Alveolar Bone ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Socket Preservation ◽  
Carbonated Hydroxyapatite ◽  
Randomized Controlled

The properties of the biodegradation of bone substitutes in the dental socket after extraction is one of the goals of regenerative medicine. This double-blind, randomized, controlled clinical trial aimed to compare the effects of a new bioabsorbable nanostructured carbonated hydroxyapatite (CHA) with a commercially available bovine xenograft (Bio-Oss®) and clot (control group) in alveolar preservation. Thirty participants who required tooth extraction and implant placement were enrolled in this study. After 90 days, a sample of the grafted area was obtained for histological and histomorphometric evaluation and an implant was installed at the site. All surgical procedures were successfully carried out without complications and none of the patients were excluded. The samples revealed a statistically significant increase of new bone formation (NFB) in the CHA group compared with Bio-Oss® after 90 days from surgery (p < 0.05). However, the clot group presented no differences of NFB compared to CHA and Bio-Oss®. The CHA group presented less amount of reminiscent biomaterial compared to Bio-Oss®. Both biomaterials were considered osteoconductors, easy to handle, biocompatible, and suitable for alveolar filling. Nanostructured carbonated hydroxyapatite spheres promoted a higher biodegradation rate and is a promising biomaterial for alveolar socket preservation before implant treatment.

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