Springfusor for Administration of Magnesium Sulphate in Preeclampsia and Eclampsia
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|ClinicalTrials.gov Identifier: NCT03549767|
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Preeclampsia and Eclampsia||Device: Springfusor Procedure: Standard of care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||241 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study is testing the acceptability of the device (springfusor) in the administration of magnesium suphate|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial to Compare Magnesium Sulphate Administration for Preeclampsia and Eclampsia: Springfusor Versus Standard of Approach|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||August 2019|
Women in this 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 through an IV infusion administered using a Springfusor pump.. The 4 gm maintenance dose will be repeated every 4 hours for 24 hours.
Springfusor for administration of magnesium sulphate
Active Comparator: Standard of care
The control group will have Magnesium sulphate administered using the Pritchard regimen, which 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
Procedure: Standard of care
Pritchard regimen. Magnesium sulphate is administered using hospital practice
- Acceptability of Springfusor [ Time Frame: At 24 hours after loading dose ]Acceptability of Springfusor for administration of magnesium sulphate will be assessed using a Likert scale ranging from one (very acceptable) to five (very unacceptable).
- Discontinuation [ Time Frame: 24 hour after the loading dose ]assessed as study participants who do not completed doses of magnesium sulphate
- Level of pain [ Time Frame: At 24 hours after loading dose ]The study participants will be asked to assess the severity of pain during the administration of magnesium sulphate using Visual analogue scale 1-7.
- Safety of springfusor [ Time Frame: within 24 hours ]Occurrence of respiratory depression eg rate <16/min
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): NCT03549767
|Contact: Sam Ononge, PhDemail@example.com|
|Contact: Annettee Nakimuli, PhDfirstname.lastname@example.org|
|Mualgo Hospital||Not yet recruiting|
|Kampala, Central, Uganda, +256|
|Contact: Sam Ononge, Phd +256772486301 email@example.com|
|Principal Investigator: Sam Ononge, PhD|
|Principal Investigator:||Sam Ononge, PhD||Makerere University College of Health Sciences|