Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201712002887266 Date of Approval: 18/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Springfusor versus standard of care in administration of magnesium sulphate
Official scientific title Randomized trial to compare Magnesium Sulphate administration for preeclampsia and eclampsia: Springfusor versus standard approach
Brief summary describing the background and objectives of the trial Background: 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 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. In addition, the IM regimen may potentially lead to abscess formation. There is a need to test an alternative way of providing Magnesium Sulphate that avoids the adverse events of IM regimens. Objective: To assess the acceptability and safety of Springfusor device in the administration of magnesium sulphate in preeclampsia and eclampsia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Preeclampsia, eclampsia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2018
Actual trial start date
Anticipated date of last follow up 30/11/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 482
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomisation Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Springfusor used in administration of magnesium sulphate Followed Zustan regimen for 24 hours loading and maintenance therapy of magnesium sulphate using IV infusion administered using a Springfusor infusion pump. The loading dose will be 4 gm of 50% magnesium sulphate in 10 ml syringe administered over 20 mins. The maintenance dose of 4 gm of 50% magnesium sulphate in 10 ml will administered over 4 hours. The 4 gm dose will be repeated every 4 hours for 24 hours 241
Control Group Standard of Care Pritchard Regimen 24 hours Loading dose administered using IV-push -health worker manually, slowly inject 4gm 20% Mag sulphate in 20ml syringe over 15-20 min.Immediately followed by IM injection of 10gm 50% mag sulphate in gluteal muscles (5gm each buttock) Maintenance dose of 5gm IM injection every 4 hrs for 24 hours 241 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Pregnant women 20+ weeks of gestation or delivered within 24 hours, 2. diagnosed with preeclampsia and eclampsia i.e. have a raised blood pressure (systolic of >140 mmHg and diastolic > 90mmHg), proteinuria >1+. 3. Present within the study period 4. consent to participate in the study. 1. Had received magnesium sulphate 24 hours prior to admission, 2) has known allergy to magnesium sulphate 3) elevated serum creatinine (>1.2 mg/dl). 15 Year(s) 48 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 06/11/2017 School of Medicine Research and Ethics committee
Ethics Committee Address
Street address City Postal code Country
Mulago Hill Kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Acceptability of Springfusor for administration of magnesium sulphate ¿ 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 rate of complications Proportion of preeclapmtics that develop complication
Secondary Outcome Level of pain The study participants will be asked to assess the severe of pain during the administration of magnesium sulphate using Visual analogue scale 1-7.
Secondary Outcome Discontinuation completed doses of magnesium sulphate in 24 hour period of including the loading dose.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago National Teaching and referral hospital Mulago hill kampala 7071 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
NURTURE: Makerere University Makerere University Kampala 7072 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor College of Health Sciences Mulago Hill Kampala 7072 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Gynuity Research Project 15 East 26th Street, Suite 801 New York, NY 10 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sam Ononge ononge2006@yahoo.com +256772486301 Mulago Hill
City Postal code Country Position/Affiliation
Kampala 256 Uganda Senior lecturer
Role Name Email Phone Street address
Public Enquiries Sam Ononge ononge2006@yahoo.com +256772486301 Mulago hill
City Postal code Country Position/Affiliation
Kampala 256 Uganda Senior lecturer
Role Name Email Phone Street address
Scientific Enquiries Sam Ononge ononge2006@yahoo.com +256772486301 Mulago Hill
City Postal code Country Position/Affiliation
kampala 256 Uganda Senior lecturer
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information