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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
Sponsor:
Information provided by (Responsible Party):
Makerere University

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.

Condition or disease Intervention/treatment Phase
Preeclampsia and Eclampsia Device: Springfusor Procedure: Standard of care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 241 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Discontinuation [ Time Frame: 24 hour after the loading dose ]
    assessed as study participants who do not completed doses of magnesium sulphate

  2. 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.

  3. Safety of springfusor [ Time Frame: within 24 hours ]
    Occurrence of respiratory depression eg rate <16/min



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Sam Ononge, PhD +256772486301 ononge2006@yahoo.com
Contact: Annettee Nakimuli, PhD +256772471618 annettee.nakimuli@gmail.com

Locations
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Uganda
Mualgo Hospital Not yet recruiting
Kampala, Central, Uganda, +256
Contact: Sam Ononge, Phd    +256772486301    ononge2006@yahoo.com   
Principal Investigator: Sam Ononge, PhD         
Sponsors and Collaborators
Makerere University
Investigators
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Principal Investigator: Sam Ononge, PhD Makerere University College of Health Sciences

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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT03549767     History of Changes
Other Study ID Numbers: REC 2018-015
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents