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.: PACTR202304555642144 Date of Approval: 11/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 12-hour Versus 24-hour Magnesium Sulfate Regimen for the Management of Severe Preeclampsia
Official scientific title The Effectiveness and Safety of 12-hour Versus 24-hour Magnesium Sulfate Regimen for the Management of Severe Preeclampsia in Sudanese Women: An Open Randomized Controlled Clinical Trial.
Brief summary describing the background and objectives of the trial One of the leading causes of maternal and neonatal morbidity and mortality is preeclampsia. The primary method for preventing seizures that could happen after preeclampsia is magnesium sulfate (MgSo4). Although magnesium sulfate medication is administered for all women with severe preeclampsia, a consensus has not yet been achieved on the minimum effective duration of MgSo4 therapy. This trial will contribute to initiatives aimed at providing safe preventive therapy for severe preeclampsia in order to avoid its associated complications. The labor wards of Wad Medani and Gedaref maternity hospitals in Sudan are participating in this multi-center hospital randomized controlled study. Pregnant women aged 18 to 40 years with a viable fetus diagnosed with severe preeclampsia and admitted to the hospital's obstetrics unit for inpatient care will be eligible for this trial. Severe preeclampsia is defined as blood pressure equal to or greater than 160/110 mm Hg at a single reading with proteinuria of 2+ on a dipstick or a 24-hour urinary protein of more than 5 g. Every participant in both arms of the study will receive a loading dose of intravenous MgSO4, followed by a maintenance dose. The primary outcome is to compare the effectiveness and safety of both methods of MgSO4 maintenance therapy. The secondary outcome is to estimate associated maternal and neonatal morbidity and mortality.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Pregnancy and Childbirth
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/03/2023
Actual trial start date
Anticipated date of last follow up 30/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Research Ethical Committee of the Department of Obstetric and Gynaecology, Faculty of Medicine, University of Gezira, Sudan.
Research Ethical Committee of the Department of Obstetric and Gynaecology, Faculty of Medicine, University of Gedaref, Sudan.
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group The 24 hour Group The patient will receive a loading dose of intravenous MgSO4 4 g given slowly as a 20% solution over 10 minutes, which will be followed by a maintenance dose as an intravenous infusion of MgSO4 5 g in 500 mL of normal saline over 5 hours, that is at 1 g/h, up to 28 g. Every participant will receive standard treatment, emergency care, and resuscitation according to the guidelines. 24 hours The patient will receive a loading dose of intravenous MgSO4 4 g given slowly as a 20% solution over 10 minutes, which will be followed by a maintenance dose as an intravenous infusion of MgSO4 5 g in 500 mL of normal saline over 5 hours, that is at 1 g/h, up to 28 g. Every participant will receive standard treatment, emergency care, and resuscitation according to the guidelines. 160 Active-Treatment of Control Group
Experimental Group The 12 hour Group The patient will receive a loading dose of intravenous MgSO4 4 g given slowly as a 20% solution over 10 minutes, which will be followed by a maintenance dose as an intravenous infusion of MgSO4 5 g in 500 mL of normal saline over 5 hours for 12 hours, up to 16 g. Every participant will receive standard treatment, emergency care, and resuscitation according to the guidelines. 12 hours The patient will receive a loading dose of intravenous MgSO4 4 g given slowly as a 20% solution over 10 minutes, which will be followed by a maintenance dose as an intravenous infusion of MgSO4 5 g in 500 mL of normal saline over 5 hours for 12 hours, up to 16 g. Every participant will receive standard treatment, emergency care, and resuscitation according to the guidelines. 160
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women with a viable fetus. Age from 18 to 44 years old. Admitted to the hospital's obstetrics unit for inpatient care. Diagnosed with severe preeclampsia. Severe preeclampsia is defined as blood pressure equal to or greater than 160/110 mm Hg at a single reading with proteinuria of 2+ on dipstick or 24-hour urinary protein of more than 5g, oliguria “urine output of less than less than 30 mL/hour, cerebral or visual disturbances, renal failure as “persistent oliguria despite of using of intravenous fluid and furosemide challenge with deranged serum electrolytes, rising creatinine greater than 1.5 mg/L, and urea greater than 45 mg/ dL”, pulmonary edema or cyanosis, epigastric or right upper quadrant pain, impaired liver function, thrombocytopenia, or fetal growth restriction. Women with any condition considered as a contraindication for MgSo4 therapy, like: Drug hypersensitivity Myasthenia gravis Anuria Oliguria Prior intake of any other anticonvulsant History of epilepsy Women with diabetes mellitus. Women with HELP syndrome (hemolysis, elevated liver enzymes, and low platelets). Adult: 19 Year-44 Year 18 Year(s) 44 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
Yes 25/07/2022 Research Ethical Committee of the Department of Obstetrics and Gynaecology. Faculty of Medicine. University of Gezira. Sudan.
Ethics Committee Address
Street address City Postal code Country
Wad Medani Maternity Hospital Road Medani 00249 Sudan
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2022 Research Ethical Committee of the Department of Obstetrics and Gynaecology. Faculty of Medicine. University of Gedaref. Sudan.
Ethics Committee Address
Street address City Postal code Country
Gedaref Maternity Hospital Road Gedaref 00249 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be a comparison of the effectiveness and safety of the 24-hour versus 12-hour maintenance doses of MgSO4 therapy on pregnant women with severe preeclampsia, which will be assessed by the occurrence of convulsions after receiving the magnesium sulfate therapy. Safety assessment will be assessed by the associated maternal adverse effects including reduced urination, respiratory difficulties/depression such as the onset of shortness of breath with a respiratory rate less than 12/minute, weakness, dizziness, hot flushes, and reduced or absent patella reflexes. 36 hours
Secondary Outcome The secondary outcome will be to estimate maternal and neonatal morbidity and mortality associated with the magnesium sulfate therapy, which includes mode of delivery, maximum BP during admission (diastolic and systolic), duration of admission, duration of urethral catheterization, maternal complications (pulmonary edema, renal insufficiency, hemodialysis, ICU admission, maternal death), gestational age at delivery, baby status at delivery, birth weight, Apgar score at 5 minutes, NICU admission and duration of it. Until discharge from the hospital or maternal/neonatal death. could reach 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wad Medani Maternity Teaching Hospital Medani Hospital Road Medani 00249 Sudan
Gedaref Maternity Teaching Hospital Gedaref Hospital Road Gedaref 00249 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Samah Mohammed Ahmed Hussein Street 60 Khartoum 00249 Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Samah Mohammed Ahmed Hussein Street 60 Khartoum 00249 Sudan Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samah M Hussein samah-173@hotmail.com 00249912327526 Street 60
City Postal code Country Position/Affiliation
Khartoum 00249 Sudan Assistant Professor of Clinical Pharmacy
Role Name Email Phone Street address
Scientific Enquiries Ishag Adam ishagadam@hotmail.com 0966537644287 Nuzha street
City Postal code Country Position/Affiliation
Khartoum 00249 Sudan Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Elhassan M Elhassan elhasans@yahoo.com 00249912945404 Medani Hospital Road
City Postal code Country Position/Affiliation
Medani 00249 Sudan Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Saeed M Omar drsaeedomar@yahoo.com 00249912950211 Gedaref Hospital Road
City Postal code Country Position/Affiliation
Gedaref 00249 Sudan Associate Professor Of Obstetric and Gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the trial's individual participant data, after being deidentified, will all be disclosed. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Starting 3 months and ending 11 months following trial completion. Data will be made available to anyone who requests it, for any form of study or purpose, and it will always be accessible at URL link (Link to be included)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information