A Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen
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|ClinicalTrials.gov Identifier: NCT02091401|
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : October 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Preeclampsia||Device: Springfusor infusion pump Other: IV administration Drug: Magnesium Sulfate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Open-label Study to Compare the Clinical Outcomes and Magnesium Serum Concentrations Obtained in the Treatment of Severe Preeclampsia With a Repeat Bolus Intravenous Magnesium Sulfate Regimen Administered With the Springfusor Infusion Pump to a Continuous Intravenous Magnesium Sulfate Regimen|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Active Comparator: 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.
Other: IV administration
Drug: Magnesium Sulfate
Women randomized into this treatment group will receive magnesium sulfate via IV infusion (with the Springfusor® pump).
Device: Springfusor infusion pump
Drug: Magnesium Sulfate
- Magnesium concentration [ Time Frame: 00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00 ]Blood draw times will be structured so as to perform a robust population PK analysis. Time zero is the end of the bolus administration. In the Springfusor arm, samples will be collected at the following times: 00:00, 00:20; 00:40; 1:20; 2:00; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00. In the IV arm, samples will be collected at the following times: 0:00; 00:20; 00:40;1:00; 1:20; 1:40; 2:20; 3:00; 3:40; 4:20; 5:20; 6:40; 8:00; 9:20; 10:40 and 12:00.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091401
|Shatby Maternity Hospital|
|El Galaa Teaching Hospital|
|Cairo, Egypt, 11511|
|Study Director:||Hillary Bracken, PhD||Gynuity Health Projects|