NCT02091401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

March 17, 2014

Last Update Submit

October 3, 2016

Conditions

Preeclampsia

Keywords

magnesium sulfate

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

IV

ACTIVE COMPARATOR

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 administrationDrug: Magnesium Sulfate

Springfusor

EXPERIMENTAL

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

Device: Springfusor infusion pumpDrug: Magnesium Sulfate

Interventions

Springfusor infusion pumpDEVICE
Springfusor
IV administrationOTHER
IV
Magnesium SulfateDRUG
IVSpringfusor

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shatby Maternity Hospital

Alexandria, Egypt

Location

El Galaa Teaching Hospital

Cairo, 11511, Egypt

Location

Related Publications (2)

  • Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.

    PMID: 37815037DERIVED

  • 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.

    PMID: 29976161DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Organization and AdministrationMagnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Health Services AdministrationMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Hillary Bracken, PhD

    Gynuity Health Projects

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 19, 2014

Study Start

January 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-10

Locations

EG(2)