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

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.

Study Overview

• Status: Unknown
• Conditions: Preeclampsia and Eclampsia
• Intervention / Treatment: Device: Springfusor; Procedure: Standard of care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 241
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sam Ononge, Phd; Phone Number: +256772486301; Email: ononge2006@yahoo.com
• Study Contact Backup: Name: Annettee Nakimuli, PhD; Phone Number: +256772471618; Email: annettee.nakimuli@gmail.com

Study Locations

• Uganda
  • Central
    • Kampala, Central, Uganda, +256
      • Mualgo Hospital
      • Contact: Sam Ononge, Phd; Phone Number: +256772486301; Email: ononge2006@yahoo.com
      • Principal Investigator: Sam Ononge, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Springfusor; 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.	Device: Springfusor; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Springfusor	Acceptability of Springfusor for administration of magnesium sulphate will be assessed using a Likert scale ranging from one (very acceptable) to five (very unacceptable).	At 24 hours after loading dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discontinuation	assessed as study participants who do not completed doses of magnesium sulphate	24 hour after the loading dose
Level of pain	The study participants will be asked to assess the severity of pain during the administration of magnesium sulphate using Visual analogue scale 1-7.	At 24 hours after loading dose
Safety of springfusor	Occurrence of respiratory depression eg rate <16/min	within 24 hours

Collaborators and Investigators

• Sponsor: Makerere University
• Investigators: Principal Investigator: Sam Ononge, PhD, Makerere University College of Health Sciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): August 1, 2019

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (ACTUAL): June 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: REC 2018-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No