Back to resultsA Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen
Primary Purpose
Preeclampsia
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Springfusor infusion pump
IV administration
Magnesium Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Preeclampsia focused on measuring magnesium sulfate
Eligibility Criteria
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 (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if 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.
Sites / Locations
- Shatby Maternity Hospital
- El Galaa Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
IV
Springfusor
Arm Description
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.
Women randomized into this treatment group will receive magnesium sulfate via IV infusion (with the Springfusor® pump).
Outcomes
Primary Outcome Measures
Magnesium concentration
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02091401
First Posted
March 17, 2014
Last Updated
October 3, 2016
Sponsor
Gynuity Health Projects
1. Study Identification
Unique Protocol Identification Number
NCT02091401
Brief Title
A Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynuity Health Projects
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
magnesium sulfate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Springfusor
Arm Type
Experimental
Arm Description
Women randomized into this treatment group will receive magnesium sulfate via IV infusion (with the Springfusor® pump).
Intervention Type
Device
Intervention Name(s)
Springfusor infusion pump
Intervention Type
Other
Intervention Name(s)
IV administration
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Primary Outcome Measure Information:
Title
Magnesium concentration
Description
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.
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Bracken, PhD
Organizational Affiliation
Gynuity Health Projects
Official's Role
Study Director
Facility Information:
Facility Name
Shatby Maternity Hospital
City
Alexandria
Country
Egypt
Facility Name
El Galaa Teaching Hospital
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
29976161
Citation
Easterling T, Hebert M, Bracken H, Darwish E, Ramadan MC, Shaarawy S, Charles D, Abdel-Aziz T, Nasr AS, Safwal SM, Winikoff B. A randomized trial comparing the pharmacology of magnesium sulfate when used to treat severe preeclampsia with serial intravenous boluses versus a continuous intravenous infusion. BMC Pregnancy Childbirth. 2018 Jul 6;18(1):290. doi: 10.1186/s12884-018-1919-6.
Results Reference
derived
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A Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen
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