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

Preeclampsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091401
• Other study ID #: 4002
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2014
• Last updated: October 3, 2016
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if 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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Device:
• Springfusor infusion pump

Other:
• IV administration

Drug:
• Magnesium Sulfate

Locations

Country	Name	City	State
Egypt	Shatby Maternity Hospital	Alexandria
Egypt	El Galaa Teaching Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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