MedTrace Logo

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

NCT02091401 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-10-04

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Springfusor infusion pump

OTHER

IV administration

DRUG

Magnesium Sulfate

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Hillary Bracken, PhD · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02091401 on ClinicalTrials.gov