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.: PACTR202404671084461 Date of Approval: 19/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Antenatal magnesium sulphate for protection of the preterm brain in women at risk preterm delivery at 28-36 weeks gestation
Official scientific title Antenatal magnesium sulphate for short term neuroprotection among women at risk of preterm delivery at 28 to 36 weeks gestation.
Brief summary describing the background and objectives of the trial Prematurity is am important cause of perinatal morbidity and mortality. Hence measures taken to improve the quality of life of preterm neonates will help to reduce the complications of preterm births. The objectives of this research are 1.to determine the modal Apgar Score between preterm neonates whose mothers had MgSO4 and those whose mothers did not have MgSO4 2. to determine the early neonatal neuro complication among preterm neonates whose mothers had MgSO4 and those whose mothers did not have MgSO4 3. to determine the relationship between MgSO4 and early neonatal neuro complications
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/07/2023
Actual trial start date 01/07/2023
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date 31/03/2024
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
HREC PR 202303076 hospital research and ethics committee university of Abuja teaching hospital
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 by using procedures such as coin-tossing or dice-rolling 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
Experimental Group Magnesium sulphate 4 grams of magnesium sulphate given intravenously followed by 5g intramuscular injection of magnesium sulphate given every 4hours for 24 hours or till delivery whichever came first 24 hours Intravenous Magnesium sulphate 50% was made up to 20% by mixing 8mls of the drug with 12mls of normal saline and given slowly over 10-15 minutes 45
Control Group No intervention was given to the control group No drug given Not applicable No intervention was given 45 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women at risk of preterm delivery between 28 to 36weeks of gestation Preterm prelabour rupture of membranes Preterm labour Planned preterm birth for maternal or fetal indication Congenital anomaly in the foetus Second stage of labour Maternal hypotension Women who received MgSO4 within the last 12 hrs Adult: 19 Year-44 Year,New born: 0 Day-1 Month 19 Year(s) 49 Year(s) Both
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 31/03/2023 University of Abuja Teaching Hospital Research and Ethics committee
Ethics Committee Address
Street address City Postal code Country
Gwagwalada Abuja Gwagwalada PMB 228 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Perinatal death and intraventricular haemorrhage in the preterm newborns At delivery and upto 28 days of life
Secondary Outcome Apgar scores at birth, type of resuscitation at birth, need for admission of the newborn, hypoxic ischaemic encephalopathy, anaemia requiring blood transfusion will serve as secondary outcomes From birth to 28 days of life
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology University of Abuja Teaching Hospital Specialist Road Abuja PMB 228 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal investigator Linda James Audu Department of Obstetrics and Gynaecology University of Abuja Teaching Hospital Abuja PMB 228 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Linda James Audu Secretariat road Abuja PMB 228 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Fashie Andrew Patrick No 15 Police Housing Estate Gwagwalada Abuja Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator LINDA Audu linda.audu@ymail.com +2348030632276 Secretariat road
City Postal code Country Position/Affiliation
Gwagwalada Nigeria Principal Investigator
Role Name Email Phone Street address
Public Enquiries Fashie Patrick andrewfashie@yahoo.co.uk +2348063399886 Dukpa Road
City Postal code Country Position/Affiliation
Gwagwalada Abuja Nigeria Public enquiries
Role Name Email Phone Street address
Scientific Enquiries Bilal Sulaiman bilalsulaimanbilal2@gmail.com +2348035609762 Specialist road
City Postal code Country Position/Affiliation
Gwagwalada Abuja Nigeria Scientific enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual patient data which I understand to be the raw data will be shared researchers or organisations without exposing the identity of participants Clinical Study Report,Informed Consent Form,Study Protocol Within 6 months Outcome of preterm delivery
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