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.: PACTR202206623958155 Date of Approval: 23/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ILIKANNU'S TRIAL
Official scientific title A COMPARISON OF THE EFFICACY OF 12-HOUR AND 24-HOUR MAINTENANCE REGIMEN OF MAGNESIUM SULPHATE FOR SEIZURE PROPHYLAXIS IN WOMEN WITH SEVERE PREECLAMPSIA: A TRIPLE BLIND RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Magnesium sulphate, administered for twenty-four hours is the drug of choice for seizure prophylaxis in patients with severe preeclampsia. Due to its narrow therapeutic index, a reduction in the duration of MgSO4 administered in the postpartum period may not only prevent the occurrence of seizures but also reduce the adverse effects associated with this drug. The aim of this study is to compare the efficacy of the 12-hour versus 24-hour postpartum MgSO4maintenance regimen in women with severe preeclampsia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 27/06/2022
Actual trial start date
Anticipated date of last follow up 05/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 146
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 12 HOUR MGSO4 ARM IM 5G(10MLS) OF MGSO4 GIVEN 4-HOURLY IN THE POST PARTUM PERIOD FOR 12HOURS THEN 10MLS OF STERILE WATER FOR INJECTION AS PLACEBO WILL BE GIVEN FOR THE REMAINING 12-HOURS IN THE POSTPARTUM PERIOD EVERY 4HOURLY FOR 24-HOURS AFTER DELIVERY THE PRITCHARDS REGIMEN OF MAGNESIUM SULPHATE ADMINISTRATION WILL BE USED. AFTER DELIVERY OF THE BABY, WOMEN IN THIS ARM WILL CONTINUE MAGNESIUM SULPHATE ADMINISTRATION 5G(10MLS) 4HOURLY FOR THE FIRST 12HOURS AFTER WHICH 10MLS OF STERILE WATER FOR INJECTION WILL BE GIVEN FOR THE REMAINING 12-HOURS. 73
Control Group 24HOUR MGSO4 ARM IM 5G OF MGSO4 GIVEN 4HOURLY IN ALTERNATE BUTTOCKS FOR 24-HOURS AFTER DELIVERY OR AFTER THE LAST FIT WHICHEVER OCCURED LAST IM 5G 4HOURLY FOR 24HOURS AFTER DELIVERY THE PRITCHARDS REGIMEN FOR MGSO4 ADMINISTRATION WILL BE USED. PATIENT WILL RECEIVE INTRAMUSCULAR 5G OF MGSO4 IN ALTERNATE BUTTOCKS 4-HOURLY FOR 24-HOURS AFTER DELIVERY OR AFTER THE LAST FIT WHICHEVER OCCURED LAST 73 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Willingness and consent to participate in the study 2. All patients above 20weeks of gestation with severe preeclampsia 3. Patients without contraindication to the use of MgSO4 (e.g drug hypersensitivity, myasthenia gravis, anuria/oliguria). 1. Eclampsia 2. Seizure disorder patients 3. Severe preeclampsia with complications like Acute renal failure, Heart failure, HELLP syndrome, pulmonary oedema 4. Prior intake of any anticonvulsant before presentation Adult: 19 Year-44 Year 18 Year(s) 45 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 11/03/2022 RESEARCH AND ETHICS COMMITTE OF THE FEDERAL MEDICAL CENTRE ASABA DELTA STATE NIGERIA
Ethics Committee Address
Street address City Postal code Country
NNEBISI ROAD, ASABA DELTA STATE NIGERIA ASABA 320213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome OCCURENCE OF SEIZURES IN BOTH ARM FROM THE POINT AFTER DELIVERY TILL DISCHARGE
Secondary Outcome TOTAL DOSE OF MGSO4 ADMINISTERED, DURATION OF URETHRAL CATHETERIZATION IN DAYS, DURATION OF HOSPITAL STAY IN DAYS, OCCURENCE OF MATERNAL MORTALITY, ADVERSE EFFECTS AND EVIDENCE OF TOXICITY CLINICALLY, MODE OF DELIVERY, ADMISSION INTO ICU, NEED TO RECOMMENCE MGSO4 FROM ADMISSION TO POINT OF DISCHARGE
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTRE ASABA DELTA STATE NIGERIA NNEBISI ROAD ASABA 320213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR ILIKANNU SAMUEL OKWUCHUKWU 2 UCHE IWUNOR STREET BEHIND CITY COMPLEX OFF NNEBISI, ASABA DELTA STATE ASABA 320233 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
PROF PETER NDIDI EBEIGBE UGBOWO ROAD BENIN Nigeria
DR OCHEI ANGELA UDUAK OKPANAM ROAD ASABA Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator SAMUEL ILIKANNU dr.ilikannu@gmail.com +2348038411984 2 Uche Iwunor Street Behind City Complex Off Nnebisi Road Asaba
City Postal code Country Position/Affiliation
Asaba 320233 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries SAMUEL ILIKANNU dr.ilikannu@gmail.com +2348038411984 2 UCHE IWUNOR STREET OFF NNEBISI
City Postal code Country Position/Affiliation
ASABA 320233 Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries PETER EBEIGBE peternebeigbe@gmail.com +2348035649146 Off Ugbowo Road
City Postal code Country Position/Affiliation
BENIN Nigeria PROFESSOR OF OBSTETRICS AND GYNAECOLOGY AND CONSULTANT OBSTETRICIAN AND GYNAECOLOGIST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes YES. All the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol MARCH 2023 TO JUNE 2023 OPEN
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