Trial Database Activities for the Simplified Treatment for the Prevention of Eclampsia with Magnesium Sulfate (STEP-Mag): A phase III, multinational, randomized, open-label, active-controlled, non-inferiority trial

Trial Database Activities for Simplified Treatment for the Prevention of Eclampsia with Magnesium Sulfate (STEP-Mag): A Phase III, Multinational, Randomized, Open-Label, Active-Controlled, Non-Inferiority Trial

Year 2022

Categories: Statistics projects, data management and information systems
Tags :Concluded

Period: 2022

Researchers:

Dr. Mabel Berrueta
Lic. Luz Gibbons
Lic. Rocío Rodriguez
Bioq. Sara Reidel
Lic. Franco Scarafia
Lic. Álvaro Ciganda
Lic. Juan José Quispe

Objective: Phase 3 clinical trial, multi-country, multicenter, two arms, parallel, open, with control arm, randomized and non-inferiority. Its main objective is to evaluate the non-inferiority of a single magnesium sulfate regimen compared to 2 standard regimens (Zuspan or Pritchard) for the prevention of maternal eclamptic seizures.

Type of study: Clinical trial

Financing: WHO