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.: PACTR202312795734215 Date of Approval: 22/12/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparison of 150mg and 75mg aspirin for preventing preterm preeclampsia and associated fetal growth restriction amongst women at risk in Abuja: a randomised controlled study
Official scientific title A comparison of 150mg and 75mg aspirin for preventing preterm preeclampsia and associated fetal growth restriction amongst women at risk in Abuja: a randomised controlled study
Brief summary describing the background and objectives of the trial SUMMARY Background: Preeclampsia (PE) affects multiple organ systems, and is a known cause of fetal, perinatal and maternal morbidity and mortality. In low resource settings like Nigeria, with high maternal and perinatal mortality, there is absolute need for early commencement of preventive measures with resultant significant reduction in cost from treatment of PE and its complications such as fetal growth restriction (FGR). Antenatal assessment of fetal growth using fetal biometric parameters on ultrasound has proven useful in diagnosing FGR. Aspirin has been found to prevent PE; the effective dose however remains an area of debate till date. Aim: The aim of this study is to determine the optimal aspirin dose for prevention of preterm preeclampsia and its associated FGR among antenatal women at increased risk in Abuja. Methodology: All consenting pregnant women between 11-16 weeks’ gestation at increased risk of preeclampsia will be recruited from the antenatal clinics of NHA and Garki Hospital Abuja. They will be divided into two groups consisting of participants who will receive 75mg and 150mg of LDA. All participants will be followed up till 37 weeks’ gestation or occurrence of PE. Specific Objectives: 1. To determine the proportion of participants that develop preterm PE among those receiving 150 mg dose of Aspirin and those receiving 75mg dose. 2. To determine the occurrence of FGR among participants receiving 150mg compared to those receiving 75mg dose in the PE group. 3. To compare the proportion of participants who develop preterm PE with other severe features among women receiving 150 mg and 75mg dose. 4. To determine the mean gestational age for developing preterm PE in participants receiving 150 mg of Aspirin compared to those receiving 75mg dose. 5. Based on finding of objectives 2, 3 and 4 above, to make recommendations for the optimal dose of Aspirin for preterm PE prevention.
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 Prevention
Anticipated trial start date 01/12/2023
Actual trial start date 04/12/2023
Anticipated date of last follow up 27/05/2024
Actual Last follow-up date 03/06/2024
Anticipated target sample size (number of participants) 95
Actual target sample size (number of participants)
Recruitment status Active, not 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Tab Aspirin 75mg One tablet of Aspirin 75mg taken once daily at bedtime From 11-16 weeks (commencement) to 36 weeks gestation (discontinuation) Early commencement of 75mg Aspirin (before 16 weeks gestation) to prevent occurence of preterm preeclampsia and its associated complication of fetal growth restriction among antenatal women at increased risk of preeclampsia according to the NICE/ACOrG guidelines 48 Dose Comparison
Experimental Group Tab Aspirin 150mg One tablet of 150mg Aspirin taken daily at bedtime From 11-16 weeks (commencement) to 36 weeks gestation (discontinuation) Early commencement of 150mg Aspirin (before 16 weeks gestation) to prevent occurence of preterm preeclampsia and its associated complication of fetal growth restriction among antenatal women at increased risk of preeclampsia according to the NICE/ACOrG guidelines 48
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i Presence of one high risk factor for preeclampsia: Previous history of hypertensive disorders of pregnancy, autoimmune diseases (SLE and APS), chronic hypertension, diabetes mellitus. ii Presence of two or more moderate risk factors for preeclampsia: ≥35 years, first pregnancy, nulliparity, BMI ≥30kg/m2, pregnancy interval >10 years, family history of preeclampsia, personal history (low birth weight or small for gestational age, and previous adverse pregnancy outcome). iii Willingness to be followed up until 37 weeks or occurrence of outcome. i Hypersensitivity to aspirin ii Long-term use of non-steroidal anti-inflammatory drugs (NSAID) iii Asthmatic patients iv Chronic liver or kidney disease v Bleeding disorders including peptic ulcer disease vi Cigarette smoking, alcohol consumption or illicit drug use vii Multifetal gestation viii Fetal congenital anomalies Adult: 19 Year-44 Year 19 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 01/09/2023 Federal Capital Territory Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
No. 1, Kapital Street, Area 11, Garki Abuja Abuja 900001 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 25/09/2023 National Hospital Abuja Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 132, Central Business District, Garki Abuja 900001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1 - Preeclampsia, defined as systolic blood pressure at ≥140 mm Hg and/or diastolic blood pressure at ≥90 mm Hg on at least two occasions measured 4 hours apart in previously normotensive women and new onset proteinuria (i.e., ≥2+ on dipstick) at or after 20 weeks of gestation. 2 - Preeclampsia-associated fetal growth restriction, defined as abdominal circumference <3rd centile at <32 weeks’ gestation (early-onset) and ≥32 weeks’ gestation (late-onset) respectively. For preecalmpsia, between 28 and 37 weeks gestation. Whereas for preeclampsia-associated fetal growth restriction, measurement will be twice between 28 and 32 weeks and between 32 and 37 weeks.
Secondary Outcome 1 - Any of the other features of severity in preeclampsia including: acute kidney injury (creatinine ≥90 μmol/L; 1mg/dL); liver involvement (elevated transaminases, e.g. alanine aminotransferase or aspartate aminotransferase >40 IU/L) with or without right upper quadrant or epigastric abdominal pain; haematological complications (thrombocytopenia–platelet count <150,000/μL, disseminated intravascular coagulation, haemolysis); neurological complications (e.g. severe headaches, persistent visual scotomata, eclampsia, altered mental status, blindness, stroke, clonus); or uteroplacental dysfunction (stillbirth). 2 - Possible adverse effects of aspirin among participants such as upper abdominal (epigastric) pain, upper gastrointestinal bleeding e.g., haematochezia or haematemesis, antepartum haemorrhage (APH). Between 28 weeks and 37 weeks gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Hospital Abuja Plot 132, Central Business District Abuja 900001 Nigeria
Garki Hospital Abuja Tafawa Balewa Road, Area 8, Garki Abuja 900001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Suraiya Auwal Suleiman Plot 132, Central Business District, Garki Abuja 900001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Suraiya Auwal Suleiman Plot 132, Central Business District Garki 900001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Suraiya Auwal Suleiman thurry88@gmail.com +2348093549439 Plot 132, Central Business District, Garki
City Postal code Country Position/Affiliation
Abuja 900001 Nigeria Senior Registrar I at National Hospital Abuja
Role Name Email Phone Street address
Public Enquiries Korede Durojaiye Wasiri drkorededurojaiye@yahoo.com +2348023733643 Plot 132, Central Business District, Garki
City Postal code Country Position/Affiliation
Abuja 900001 Nigeria Chief Consultant
Role Name Email Phone Street address
Scientific Enquiries Ochuwa Babah ochuwab@yahoo.co.uk +2347038090032 Ishaga road, Idi-Araba
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Professor of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Ibrahim Yakasai ibrahimyakasai57@hotmail.com +2348032349387 Plot 132, Central Business District, Garki
City Postal code Country Position/Affiliation
FCT 900001 Nigeria Visiting ProfessorNational Hospital Abuja
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data (IPD) summary results. All of the individual data collected during the trial, after de-identification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol July 2024 to November 2024 Not applicable yet
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