Clinical trial NCT03549767: Springfusor for Administration of Magnesium Sulphate in Preeclampsia and Eclampsia
Official title: Randomized Trial to Compare Magnesium Sulphate Administration for Preeclampsia and Eclampsia: Springfusor Versus Standard of Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preeclampsia and Eclampsia
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 241
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is testing the acceptability of the device (springfusor) in the administration of magnesium suphate
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. The study will include pregnant women with age of 15 years and above
2. Pregnancy of 20+ weeks of gestation or delivered within 24 hours,
3. Presenting with preeclampsia and eclampsia i.e. have a raised blood pressure (systolic of \>140 mmHg and diastolic \> 90mmHg), proteinuria \>1+.
4. Presenting within the study period
5. Consent to participate in the study.

Exclusion Criteria:

1. Pregnant women or delivered within 24 hours who admitted with had received magnesium sulphate 24 hours prior to admission,
2. Has known allergy to magnesium sulphate and
3. Has elevated serum creatinine (\>1.2 mg/dl). However the participants may be enrolled prior to the knowledge of serum creatinine, but withdrawn if the level is \>1.2 mg/dl.

Primary outcomes:
measure: Acceptability of Springfusor
timeFrame: At 24 hours after loading dose
Secondary outcomes:
measure: Discontinuation
timeFrame: 24 hour after the loading dose
measure: Level of pain
timeFrame: At 24 hours after loading dose
measure: Safety of springfusor
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mualgo Hospital
state: Central
Study officials:
affiliation: Makerere University College of Health Sciences
name: Sam Ononge, PhD
role: PRINCIPAL_INVESTIGATOR
References: