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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IV

Women randomized into this treatment group will receive magnesium sulfate via an IV loading dose administered manually by study staff and an IV maintenance regimen.

Group Type ACTIVE_COMPARATOR

IV administration

Intervention Type OTHER

Magnesium Sulfate

Intervention Type DRUG

Springfusor

Women randomized into this treatment group will receive magnesium sulfate via IV infusion (with the Springfusor® pump).

Group Type EXPERIMENTAL

Springfusor infusion pump

Intervention Type DEVICE

Magnesium Sulfate

Intervention Type DRUG

Interventions

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Springfusor infusion pump

Intervention Type DEVICE

IV administration

Intervention Type OTHER

Magnesium Sulfate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Exhibit systolic blood pressure \> 160mm Hg OR a diastolic pressure \> 110 mm Hg (at two times over 30 minutes) (A single higher pressure could be accepted if the clinical team felt that magnesium sulfate therapy should be initiated without waiting 30 minutes).

Exhibit proteinuria \> 1+; Have not given birth, or be \<24h postpartum Be assessed by enrolling physician to benefit from magnesium sulfate therapy Agree to comply with study procedures Be \> 18 years of age Give informed consent for study participation

Exclusion Criteria

Eclamptic or seizing at the time of enrollment Received magnesium sulfate therapy 24h prior to study enrollment Known serum creatinine \>1.2 mg/dL. (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if \>1.2 mg/dL in order to have a proper dose adjustment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No