scholarly journals Efficacy of Thunder-Fire Moxibustion In Treating Ankylosing Spondylitis of Kidney Deficiency And Governor Meridian Cold And Its Influence On Bone Metabolism：Study Protocol For A Randomized Controlled Trial

2021 ◽  
Author(s):  
Yang Liu ◽  
Pei Wang ◽  
Yanyan Sun ◽  
Jing Qu ◽  
Min Li
Keyword(s):  
Ankylosing Spondylitis ◽  
Randomized Trial ◽  
Activity Index ◽  
Controlled Trial ◽  
Prospective Randomized Trial ◽  
Heat Radiation ◽  
Secondary Outcome ◽  
Control Group ◽  
Kidney Deficiency ◽  
Basic Treatment

Abstract Background: Ankylosing spondylitis(AS) is a common chronic inflammatory spondyloarthropathy,.It is considered in Traditional Chinese Medicine(TCM) that the pathogenesis of AS is mainly due to Yang deficiency of kidney governor meridian and internal prosperity of cold evil. Thunder-fire moxibustion is a kind of moxibustions and characterized in abundance in drug composition, high heat radiation and strong penetration. Thunder-fire moxibustion on spinal segment of governor meridian in treating AS seems compatible with the main pathogenesis of kidney deficiency and governor meridian cold. The Trial aims to explore the efficacy of thunder-fire moxibustion in patients with AS of kidney deficiency and governor meridian cold and its influence on bone metabolism, through a prospective randomized trial. Methods: Sixty patients with AS of kidney deficiency and governor meridian cold will be recruited and randomly assigned to the treatment group （thunder-fire moxibustion three times a week plus basic treatment）and the control group (basic treatment) at the Center of TCM of Beijing Luhe Hospital Affiliated to Capital Medical University (Beijing, China), Each patient will be treated for 4 weeks.Primary outcome indexes will include efficacy of TCM syndrome,Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI),with observation once respectively prior to the treatment, 2 weeks post to the treatment, and at the end of the treatment. Secondary outcome indexes will include tumor necrosis factor-α(TNF-α) and receptor activator of nuclear factor-κ B ligand(RANKL), which will be determined once respectively before and after treatment.Side effects during the treatments will be recorded and analyzed as well. Inter-group comparison and analysis will be performed based on intention-to-treat set and per-protocol set. Discussion: This prospective randomized trial will help verify the efficacy of thunder-fire moxibustion in treating AS of kidney deficiency and governor meridian cold, discuss preliminarily its mechanism in treating this disease, and provide high-quality evidences for scientific researches on clinical treatment with thunder-fire moxibustion against AS. Trial registration: Chinese Clinical Trial Registry, ChiCTR2100044227 . Registered on 12 March 2021.

scholarly journals The Clinical and MRI Effect of TNF-α Inhibitors in Spondyloarthritis Patients With Hip Involvement: A Real-World Observational Clinical Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Kui Zhang ◽  
Yan Zheng ◽  
Qing Han ◽  
Ying Liu ◽  
Weitao Wang ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Activity Index ◽  
Group Versus ◽  
Quantitative Mri ◽  
Harris Hip Score ◽  
Control Group ◽  
Hip Arthritis ◽  
Tnf Α ◽  
Basic Treatment

ObjectivesHip involvement is an important cause of disability and poor prognosis in patients with spondyloarthritis (SpA). Tumor necrosis factor (TNF)-α inhibitor treatment has been demonstrated to be effective in SpA patients with hip arthritis; however, quantitative assessment using MRI in long-term follow-up needs further application and observation.MethodsA total of 239 patients were involved in this study. Methotrexate and sulfasalazine were given as basic treatment. In total, 165 patients received TNF-α inhibitors plus basic treatment, and 74 received basic treatment only, as controls. Clinical symptoms were assessed at baseline and at weeks 12, 24, and 52. MRI performances of hip arthritis, including bone marrow edema (BME) and synovitis, were quantitatively assessed using the Hip Inflammation MRI Scoring System (HIMRISS).ResultsThe clinical values of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Harris hip score, and Ankylosing Spondylitis Disease Activity Score (ASDAS)-ESR in both groups showed significant clinical remission at week 52 (p < 0.001). However, the change in disease activity levels at week 52 in the control group was significantly worse than in the TNF-α inhibitor group. At week 52, MRI showed a significant remission trend in the TNF-α inhibitor group versus baseline, and total HIMRISS scores were significantly decreased (26.49 ± 10.37 vs. 20.59 ± 9.41, p < 0.001); the control group only had slight improvement (p < 0.05).ConclusionsTNF-α inhibitors could significantly improve clinical and MRI manifestations of hip involvement in patients with SpA. Quantitative MRI assessment combined with clinical assessment can be used to accurately evaluate the treatment effect of TNF-α in SpA patients with hip involvement to help guide targeted treatment.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

Fascial treatment versus manual therapy (HVLA) in patients with chronic neck pain: A randomized controlled trial

2021 ◽  
pp. 1-10
Author(s):  
Katrin Brück ◽  
Kirsten Jacobi ◽  
Tobias Schmidt
Keyword(s):  
Neck Pain ◽  
Manual Therapy ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
Chronic Neck Pain ◽  
Secondary Outcome ◽  
Control Group ◽  
Industrialized Nations

BACKGROUND: Chronic neck pain (CNP) is a common health problem in western industrialized nations. In recent years, the fascial tissue has attracted the attention of therapists, and a treatment of the fasciae promises to be a meaningful approach in the therapy of patients with CNP. OBJECTIVE: The aim of this study was to investigate the effectiveness of a fascial treatment (FT) compared to manual therapy (MT) and to no intervention (control group, CG) in patients with CNP. METHODS: Sixty participants with CNP were randomized into three groups. Primary outcome parameters were pain intensity as measured by the visual analogue scale (VAS), and severity of illness as measured by the Neck Pain and Disability Scale (NPAD). Secondary outcome parameter was the range of motion (ROM) of the cervical spine. RESULTS: Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD: dR⁢M= 0.72). CONCLUSION: Our results confirmed the effectiveness of MT on pain and severity of illness in the treatment of patients suffering from CNP. Furthermore, the results demonstrated the effectiveness and clinical relevance of FT for this population.

scholarly journals Effect of KAP Intervention Model on Resilience and Cancer-related Fatigue in Patients with Colorectal Cancer Undergoing Chemotherapy

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Hui Zhang
Keyword(s):  
Colorectal Cancer ◽  
Randomized Trial ◽  
Cancer Chemotherapy ◽  
Prospective Randomized Trial ◽  
Control Group ◽  
Observation Group ◽  
Intervention Model ◽  
Cancer Related Fatigue ◽  
Resilience Scale ◽  
The Difference

Objective: To explore the effect of KAP intervention mode on resilience and cancer-related fatigue in patients with colorectal cancer undergoing chemotherapy. Methods: A prospective randomized trial was conducted. 55 patients with colorectal cancer who received routine nursing from February 2018 to February 2019 were included in the control group, and 55 patients who received routine nursing + KAP intervention from March 2019 to March 2020 were included in the observation group. The scores of Resilience Scale and cancer-related fatigue scale (CFS) before and 6 months after intervention were compared between the two groups. Results: After 6 months of intervention, the score of resilience of the two groups was higher than that before intervention, and that of the observation group was higher than that of the control group, the difference was statistically significant (P < 0.05); The CFS score of the two groups was lower than that before intervention, and that of the observation group was lower than that of the control group, the difference was statistically significant (P < 0.05). Conclusion: KAP intervention model can improve the resilience of patients with colorectal cancer chemotherapy, reduce cancer-related fatigue.

scholarly journals Assessment of Ankylosing Spondylitis Activity During Pregnancy Using Different Disease Activity Indices

2020 ◽  
Vol 58 (5) ◽  
pp. 503-511
Author(s):  
O. A. Krichevskaya ◽  
Z. M. Gandaloeva ◽  
S. I. Glukhova ◽  
I. Yu. Skripkina ◽  
A. B. Demina ◽  
...  
Keyword(s):  
Back Pain ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Pregnant Women ◽  
Activity Index ◽  
Disease Activity Index ◽  
Control Group ◽  
Mean Values ◽  
In Pregnancy ◽  
Activity Indices

Objective: Assessment of ankylosing spondylitis activity patterns during pregnancy using BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score — C-Reactive Protein) disease activity indices.Materials and methods. The prospective study included 36 pregnant women with AS (modified New York AS criteria, 1984). Patients’ mean age was 31.6±4.8 years, mean age at AS onset was 21.8±10.9, and disease duration 134.9±89.3 months. The control group included 30 healthy pregnant women with no history of back pain and arthritis, their mean age was 28.2±4.5 years. In the I trimester of pregnancy 10 (33.3%) As patients experienced back pain, while in the III trimester already 15 (50%) had back pain. Throughout pregnancy, the intensity of back pain in the I, II и III trimesters based on numeric scale was on average 1.9±0.9; 2.1±1.1 and 2.1±0.8. BASDAI and ASDAS-CRP were used to measure disease activity on gestational Weeks 10–11, 20–21 and 31–32. The time of conception BASDAI score was assessed retrospectively at the 1st visit.Results and discussion. BASDAI mean values at the time of conception and I, II и III trimesters of pregnancy were: 2.3±1.9; 2.8±1.72 (p<0,05 vs month of conception); 3.2±1.9 and 3.3±2.1 respectively. Mean ASDAS-CRP in the I, II и III trimesters were 1.9±0.7; 2.3±0.9 and 2.2±0,8 respectively. There was a trend to CRP increase in the II and III trimesters vs the I: median CRP values in the I, II and III trimesters were 5.7 [1.6; 6.2], 8.0 [2.1; 9.6] and 7.9 [2.0; 9.2] mg/L, respectively. Percentages of patients with high disease activity based on BASDAI scores in the I, II and III trimesters were 30.6; 34.3 and 34.3%; based on ASDAS-CRP — 36.1; 57.5 and 53%, respectively. Throughout pregnancy, BASDAI scores were lower in the control group than in AS patients (p<0.01). However, no differences were found when comparing BASDAI values of AS patients and healthy women with back pain during pregnancy. The level of fatigue did not differ between pregnant women with AS (median 5[3; 7] and 5[3; 6]) and healthy controls (5[3; 8] and 5[4; 6]) in the I and II trimesters, while in the III trimester, fatigue in healthy pregnant women (6[4; 8]) was more pronounced than in AS patients (5[3; 6], p=0.01). Throughout pregnancy, the intensity of back pain in AS patients and healthy pregnant women with back pain did not differ (p<0.05). Median pain intensity in the I, II and III trimesters was 3[2; 4]; 4[3; 5]; 3[2; 6] and 2,5[1; 4]; 3[2; 7]; 4[2; 6], respectively. A high (rs ≥0,7) correlation of all BASDAI components with the index itself in each trimester of pregnancy, except for joint pain in the month of conception, and in the I and III trimesters was established in the group of pregnant women with AS. The control group had quite high correlation (rs >0.7) of fatigue severity with the BASDAI index in the I and II trimesters of pregnancy and moderate correlation (rs >0.53) in the III trimester; as wells as moderate (rs >0.5-0.69) correlation between back pain and BASDAIConclusion. A trend towards increasing AS activity based on BASDAI and ASDAS-CRP scores and CRP levels was established for the first half of pregnancy. Later in pregnancy these increased values failed to return to normal until the end of gestation. The percentage of AS patients with highto-moderate disease activity throughout pregnancy was lower based on BASDAI score vs based on ASDAS-CRP. Some BASDAI components (fatigue and back pain) reflect not only the activity of AS, but also changes associated with physiological pregnancy. The BASDAI index requires adaptation for use in pregnancy

Effects of golf training on cognition in older adults: a randomised controlled trial

2018 ◽  
Vol 72 (10) ◽  
pp. 944-950 ◽  
Author(s):  
Hiroyuki Shimada ◽  
Sangyoon Lee ◽  
Masahiro Akishita ◽  
Koichi Kozaki ◽  
Katsuya Iijima ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Training Group ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Control Group ◽  
Logical Memory ◽  
Randomised Controlled

BackgroundAlthough research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults.MethodsWe conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older. Participants were randomly assigned to either a 24-week (90–120 min sessions/week) golf-training group or a health education control group. Postintervention changes in Mini-mental State Examination (MMSE) and National Centre for Geriatrics and Gerontology-Functional Assessment Tool scores were regarded as primary outcome measures. Secondary outcome measures included changes in physical performance and Geriatric Depression Scale (GDS) scores.ResultsA total of 100 participants (golf training, n=53; control, n=47) completed the assessments after the 24-week intervention period. The adherence to the golf programme was 96.2% (51/53 participants). Analysis using linear mixed models revealed that the golf training group exhibited significantly greater improvements in immediate logical memory (p=0.033), delayed logical memory (p=0.009) and composite logical memory (p=0.013) scores than the control group. However, no significant changes in MMSE, word memory, Trail Making Test or Symbol Digital Substitution Test scores were observed. In addition, no significant changes in grip strength, walking speed or GDS were observed.ConclusionsGolf-based exercise interventions may improve logical memory in older adults, but no significant changes in other cognitive tests. Further follow-up investigations are required to determine whether the observed effects are associated with delayed onset of mild cognitive impairment or Alzheimer’s disease in older adults.Trial registration numberUMIN-CTR UMIN000024797; Pre-results.

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

2021 ◽  
Author(s):  
Angela Chu ◽  
Tyler M Rose ◽  
Danielle A Gundrum ◽  
Tressa E McMorris ◽  
Eytan A Klausner ◽  
...  
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Intervention Period ◽  
Entire Study ◽  
Positive Effects ◽  
Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000011440
Author(s):  
Jong-Won Chung ◽  
Won Hyuk Chang ◽  
Oh Young Bang ◽  
Gyeong Joon Moon ◽  
Suk Jae Kim ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Controlled Trial ◽  
Outcome Evaluation ◽  
Autologous Serum ◽  
Secondary Outcome ◽  
Control Group ◽  
Link Type ◽  
Significant Difference ◽  
Major Stroke

ObjectiveTo test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.MethodsIn this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.ResultsA total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range, 28–83) years, and mean interval between stroke onset to randomization was 20.2 (range, 5–89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months (p = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index, p = 0.023), which was notable among patients with low predicted recovery potential. There were no serious, treatment-related adverse events.ConclusionsIntravenous application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.Classification of evidenceThis study provides Class III evidence that autologous mesenchymal stem cells do not improve 90-day outcomes in patients with chronic stroke.Trial registrationclinicaltrials.gov Identifier: NCT01716481.

Abstract WP221: Very Brief Intervention Improves Stroke Response in a Randomized Trial: Stroke Ready Very Brief Intervention

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Lesli E Skolarus ◽  
Maria Cielito Robles ◽  
Springer Mellanie ◽  
Chun Chieh Lin ◽  
Casey Corches ◽  
...  
Keyword(s):  
Brief Intervention ◽  
Action Plan ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Average Score ◽  
Control Group ◽  
Symptom Recognition ◽  
Stroke Symptom ◽  
One To One

Introduction: Stroke pre-hospital delay has not improved over time. Hypothesis: Stroke Ready, a very brief (5 minute), theory based, peer-led, stroke preparedness intervention, will increase stroke response compared with a control intervention. Methods: We performed a randomized, single-blind controlled trial among adults in Flint, MI. The stroke preparedness intervention group received a Stroke Ready pamphlet and action plan, while the control group received stroke prevention materials - both delivered during a one-to-one interaction with a trained peer educator. Research staff, blinded to group intervention assignment, assessed baseline and immediate post-intervention outcomes. Primary outcome was change in stroke response (behavioral intent to call 911) using a community-modified stroke action test (range 0-12). Secondary outcome was change in stroke symptom recognition (range 0-8). We conducted descriptive analyses and used a linear regression model to evaluate the effect of the intervention on stroke response after adjustment for pre-intervention intent, age, education, race, marital status, history of stroke, stroke in someone they know and psychological constructs. Results: We enrolled 129 participants (74 intervention; 55 control). Mean age was 60 years (SD 14); 61% were women, 89% were African American and 19% were not high school graduates. Intervention participants had greater improvement in stroke response than control participants (figure 1), which remained after full adjustment (improvement in average score for stroke response was 1.7 higher in intervention participants than control participants, 95% CI 0.9-2.5, p<0.0001). There was no difference in stroke symptom recognition (figure 1). Conclusion: The Stroke Ready very brief intervention increased stroke response. This new approach using a very brief, one-to-one interaction with trained peer educators is a promising, scalable, intervention to increase stroke response.

scholarly journals Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032799 ◽  
Author(s):  
Titus Beyuo ◽  
Emma Lawrence ◽  
Elizabeth S Langen ◽  
Samuel A Oppong
Keyword(s):  
Randomised Controlled Trial ◽  
Health Outcomes ◽  
Magnesium Sulfate ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
University Of Michigan ◽  
Clinical Trial Registry ◽  
Randomised Controlled ◽  
Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

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