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)
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
Description
Keywords
Treatment for eclampsia