Springfusor for Administration of Magnesium Sulphate in Preeclampsia and Eclampsia

Makerere University

Status: Unknown

Conditions: Preeclampsia and Eclampsia

Treatments: Device: Springfusor; Procedure: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT03549767

REC 2018-015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 241 estimated patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

241 participants in 2 patient groups

Springfusor

Experimental group

Description:

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.

Treatment:

Device: Springfusor

Standard of care

Active Comparator group

Description:

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

Treatment:

Procedure: Standard of care