NCT03549767

Springfusor for Administration of Magnesium Sulphate in Preeclampsia and Eclampsia

Randomized Trial to Compare Magnesium Sulphate Administration for Preeclampsia and Eclampsia: Springfusor Versus Standard of Approach

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (estimated)
• Sponsor: Makerere University · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Magnesium Sulphate is the drug of choice for prevention and treatment of seizures in preeclampsia and eclampsia. It is administered parenterally by intravenous (IV) and or intramuscular (IM) routes. The IM regimen requires repeated painful injections which may be a barrier to optimal utilization whereby, there is frequent omission of some doses or increased interval between maintenance doses and low patient acceptability of magnesium. The study plans to assess the acceptability and safety of Springfusor device in the administration of magnesium sulphate in preeclampsia and eclampsia.

Detailed description

The IM regimen used in low resource settings, requires repeated painful injections which may be a barrier to optimal utilization whereby, there is frequent omission of some doses or increased interval between maintenance doses and low patient acceptability of magnesium. The study plans to assess the acceptability and safety of Springfusor device in the administration of magnesium sulphate in preeclampsia and eclampsia. It is open label clinical randomized trail conducted at Mulago national referral and teaching hospital, where, 482 women diagnosed with preeclampsia and eclampsia will be randomized in blocks to either Springfusor device or standard of care for the administration of magnesium sulphate. Women in the Springfusor group will have their loading dose (4 gm of 50% Magnesium sulphate in 10 ml syringe administered over 20 minutes) and maintenance therapy (4 gm of 50% Magnesium sulphate in 10 ml syringe administered over 4 hours. The 4 gm maintenance dose will be repeated every 4 hours for 24 hours) of Magnesium sulphate through an IV infusion administered using a Springfusor pump. The control group will have Magnesium sulphate administered according to the Pritchard regimen (standard hospital practice). The Pritchard regimen involves administration of loading dose of 4 gm of 20% Magnesium sulphate IV over 15-20 minutes, immediately followed by 10 gm of 50% Magnesium sulphate IM (5gm on each buttock). The maintenance dose of 5 gm of 50% Magnesium sulphate IM every 4 hourly in alternate buttocks continued for 24 hours. The primary outcome is the acceptability of administration of Magnesium sulphate using Springfusor assessed using a Likert scale. The other outcomes are discontinuation and complications in the two arms. Analysis will be intention to treat.

Conditions

• Preeclampsia and Eclampsia

Interventions

Type	Name	Description
DEVICE	Springfusor	Springfusor for administration of magnesium sulphate
PROCEDURE	Standard of care	Pritchard regimen. Magnesium sulphate is administered using hospital practice

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-04-01
• Completion: 2019-08-01
• First posted: 2018-06-08
• Last updated: 2018-06-08

Locations

1 site across 1 country: Uganda