Simplified Treatment for Eclampsia Prevention using Magnesium sulfate: A phase III, randomized,open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial)
| dc.contributor.author | Gadama, Luis | |
| dc.date.accessioned | 2021-11-25T10:02:37Z | |
| dc.date.available | 2021-11-25T10:02:37Z | |
| dc.date.issued | 2021-11-04 | |
| dc.description.abstract | This is a hospital-based, multicenter, two-arm, parallel, open label, active-controlled, randomized, non-inferiority trial. The problem Hypertensive disorders are associated with severe maternal morbidity and hypertensive sequel to mothers and their babies. Pre-eclampsia and eclampsia are the second leading causes of maternal mortality in Malawi and worldwide with excessively larger occurrence in, low- and middle-income countries. Parental Magnesium Sulphate is the anticonvulsant of choice for women with preeclampsia and eclampsia. Due to potential drug toxicities, the treatment is confined to higher levels of care other than Primary level posing a missed opportunity in preventing pre-eclampsia progression to eclampsia. Intramuscular injection with the omission of Intravenous infusion (Iv) remain the dominant route of administration in low and middle countries where resources and skilled staff are limited. Determining alternative methods and regimen to improve treatment coverage among pre and eclamptic women and widening the task sharing base to improving maternal outcomes remain imperative. Objectives The main objectives of the study isare to evaluate superiority level of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IM (Pritchard) magnesium sulfate regimen: Specifically, the study will 1. Evaluate non-inferiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen in the prevention of maternal eclamptic seizure. 2. Evaluate superiority of magnesium sulfate 10g IM administered 12 hourly x 2 doses compared with a standard IV (Zuspan) or IM (Pritchard) magnesium sulfate regimen in the proportion of women experiencing adverse events indicative of magnesium toxicity Methods A hospital-based, multicenter, two-arm, parallel, open label, active-controlled, randomized, noninferiority trial conducted at Queen Elizabeth Central Hospital, Zomba Central Hospital, Kamuzu Central Hospital and Bwaila Hospital. The study will start with a pilot study. An interim analysis will be conducted for an independent Data Safety Monitoring Committee (DSMC) and a Trial Steering Committee (TSC) to assess safety, futility, feasibility of recruitment, randomization, adherence to allocated treatment, and retention of trial participants. The study will recruit women admitted with pre-eclampsia during pregnancy, labour or within 24 hours of childbirth, whether with single or multiple tone gestation. Participating women will be randomized to receive the simplified regimen or either the standard IV (Zuspan) or IM (Pritchard) regimen, depending on the standard treatment protocol in the participating hospitals. Dissemination Data and Reports will be shared with the sponsors and the Malawi College of Medicine and Malawi College of Medicine Research Ethics Committee and published in peer reviewed publications | en_US |
| dc.description.sponsorship | World Health Organization | en_US |
| dc.identifier.uri | http://rscarchive.kuhes.ac.mw/handle/20.500.12988/449 | |
| dc.language.iso | en | en_US |
| dc.relation.ispartofseries | Ethics Approval;P.07/21/3358 | |
| dc.subject | Treatment for eclampsia | en_US |
| dc.title | Simplified Treatment for Eclampsia Prevention using Magnesium sulfate: A phase III, randomized,open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial) | en_US |