drugset / Trial / NCT02091401

A Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen

NCT02091401

Phase 4 Completed 200 enrolled Gynuity Health Projects
RandomizedParallel-groupOpen-labelTreatment

Summary

The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the Springfusor® controlled pump to a continuous intravenous regimen. The goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the continuous intravenous and Springfusor repeat bolus regimens. The study will also document the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.

Timeline

Start
2015-01
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Magnesium Sulfate Other / unclassified 1 g Intravenous
Subject Magnesium Sulfate Other / unclassified 2 g Intravenous

Indications