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.: PACTR202401609294319 Date of Approval: 02/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study of Twelve Versus Twenty-Four Hours Magnesium Sulphate Regimens for Prevention of Postpartum Eclampsia in Preeclamptics with Severe Features.
Official scientific title Randomized Controlled Study of Twelve Versus Twenty-Four Hours Magnesium Sulphate Regimens for Prevention of Postpartum Eclampsia in Preeclamptics with Severe Features.
Brief summary describing the background and objectives of the trial Background: Preeclampsia-eclampsia spectrum is one of the leading causes of maternal and perinatal morbidity and mortality globally and magnesium sulphate (MgSO4) has been shown to be effective in its management. However, there remains no consensus on the duration of postpartum maintenance dose of MgSO4 with multiple protocols in use. General Aims and Objectives: To compare the outcome of 12-hour to 24-hour postpartum MgSO4 regimen in the prevention of convulsion in women with preeclampsia with severe features at University of Ilorin Teaching Hospital (UITH), Ilorin, Nigeria.
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 01/02/2023
Actual trial start date 01/03/2023
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date 30/09/2023
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 74
Recruitment status Completed
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Postpartum magnesium sulphate therapy 1g/hr 12 hours Loading dose: all the recruited participants will receive a loading dose of 4 g of intravenous MgSO4 in 100 mL of normal saline over 10-20 minutes via gravity-fed infusion drip set. Maintenance dose antepartum: all the participants will be commenced on intravenous 1g MgSO4 /hr./83 mL normal saline that will be continued until the end of the third stage of labour at the rate of 28 drops per minute. participants in this group will be administered 1g MgSO4/hr./83ml normal saline intravascular over 12 hours at the rate of 28 drops per minute. 39
Control Group 24 hour group 1g/hour/ for 24hours 24 hours 1g MgSO4/hr./83ml normal saline intravascular over 12 hours and a repeat regimen after the first one is exhausted to complete 24 hours regimen. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women at gestational age ≥ 28 weeks with live intrauterine fetus(es) scheduled for delivery or in labour. 2. Clinical diagnosis of preeclampsia with severe features using the American College of Obstetrics and Gynaecology (ACOG) as stated in the introduction. 1. Comorbid maternal diagnosis of renal disease and/or seizure disorder. 2. Contraindication to MgSO4 (drug hypersensitivity, myasthenia gravis, anuria or oliguria i.e., urine output less than 25ml/hour). 3. Prior administration of any other anticonvulsants (e.g., Diazepam, phenytoin) within 24 hours before recruitment. 4. Prior administration of MgSO4 within 72 hours which is not a component of the study regimens. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 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 26/07/2022 Health Research Committe
Ethics Committee Address
Street address City Postal code Country
Old Jebba road, Oke-Ose Ilorin Ilorin 234 Nigeria
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 26/07/2023 Health Research Committe
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, Oke-Ose Ilorin 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of eclampsia during or after completion of the assigned magnesium sulphate regimen. first 48 hours postpartum
Secondary Outcome • Serial maternal serum magnesium level (Samples for serum magnesium levels will be taken from the participants before the commencement of magnesium sulphate therapy, at the occurrence of convulsion, if any and at 48 hours postpartum.) • Time of ambulation after delivery • Clinical evidence of toxicity (absent tendon reflexes, respiratory rate <12 cycle per minute, cardiac arrest). first 48 hours postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital Old Jebba road, Oke-Ose Ilorin 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Residency Training Fund Old Jebba Road, Oke-Ose Ilorin 234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Ilorin Teaching Hospital Old Jebba road, Oke-Ose Ilorin 234 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwole Ogunwumi worlexy@gmail.com +2348055676025 No 31 Prince Street, Ajegunle area
City Postal code Country Position/Affiliation
Ilorin 234 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Abiodun Adeniran acrowncord@hotmail.com +2348057534788 Old Jebba road, Oke-Ose
City Postal code Country Position/Affiliation
Ilorin 234 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Sikiru Biliaminu biliaminusa@unilorin.edu.ng +2348060885920 Old Jebba road, Oke-Ose
City Postal code Country Position/Affiliation
Ilorin 234 Nigeria Consultant chemical pathologist
Role Name Email Phone Street address
Scientific Enquiries AbdulWaheed Olatinwo jolatinwo@yahoo.com 2348037206303 Old Jebba road, Oke-Ose
City Postal code Country Position/Affiliation
Ilorin 234 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Fatai Olaniyi niyibola777@gmail.com +2347061558863 Old Jebba road, Oke-Ose
City Postal code Country Position/Affiliation
Ilorin 234 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after de-identification, will be shared, including the study protocol, statistical analysis plan, informed consent form, and analytic code. The data will be available within 12 months of study completion. Informed Consent Form within of the study completion 12 months Complete access
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