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.: PACTR202403785563823 Date of Registration: 12/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The PEARLS Trial
Official scientific title Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening A multi-country, multi-centre, two-arm, parallel, double-blind, randomised trial of low-dose aspirin for women at increased risk pre-eclampsia in Ghana, Kenya and South Africa, to prevent pre-eclampsia and improve maternal and newborn outcomes.
Brief summary describing the background and objectives of the trial There is uncertainty surrounding the safest and most effective dosage of aspirin in low-, middle-, and high-income countries. In WHO’s 2021 recommendations, the need for a study comparing a 75 mg dose to a 150 mg dose was recognized as a high research priority. This trial will evaluate a regimen of 150 mg daily oral aspirin (intervention) compared to 75 mg daily oral aspirin (control), in women who are identified as being at risk of pre-eclampsia based on a restricted-variable FMF screening algorithm. Primary objectives: 1) To compare the effect of a regimen of daily 150mg aspirin to a regimen of 75mg aspirin on the occurrence of birth at <37 weeks with pre-eclampsia, when given to women at high risk of pre-eclampsia according to a screening algorithm. 2) To compare the effect of a regimen of daily 150mg aspirin to a regimen of 75mg aspirin on the occurrence of a composite measure of PPH-related treatment, when given to women at high risk of pre-eclampsia according to a screening algorithm.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PEARL
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 15/12/2024
Actual trial start date
Anticipated date of last follow up 30/06/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 20576
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
KNHERC01MISC20 Kenyatta National Hospital University of Nairobi Ethics Review Committee
202328461481572 University of Melbourne Ethics number
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 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 Daily oral aspirin 150mg Once daily (nocte) From time of recruitment (<20 weeks’ gestation) until 36 weeks’ gestation, childbirth, fetal death or pre-eclampsia is diagnosed, whichever occurs first. The intervention regimen is daily oral aspirin 150mg once daily (nocte) from time of recruitment (<20 weeks’ gestation) until 36 weeks’ gestation, childbirth, fetal death or pre-eclampsia is diagnosed, whichever occurs first. 10288
Control Group Daily oral aspirin 75mg once daily (nocte) From time of recruitment (<20 weeks’ gestation) until 36 weeks’ gestation, childbirth, fetal death or pre-eclampsia is diagnosed, whichever occurs first. The control (standard treatment) regimen is daily oral aspirin 75mg once daily (nocte) from time of recruitment (<20 weeks’ gestation) until 36 weeks’ gestation, childbirth, fetal death or pre-eclampsia is diagnosed, whichever occurs first. 10288 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pregnant women at <20 weeks’ gestation, identified as being at high risk of pre-eclampsia, according to the restricted-variable FMF algorithm combining maternal history and MAP • Women with any live pregnancy (singleton or multiple). • Women intend to give birth in a participating study facility/care network • Women identified by FMF screening algorithm as low risk • Women with a known contraindication to antiplatelet therapy, such as hypersensitivity reaction to any NSAID, or patients with asthma who have a history of aspirin-induced acute bronchospasm • Multiple pregnancy • Women with known bleeding disorders (such as von Willebrand’s disease or peptic ulceration) • Long-term use of nonsteroidal anti-inflammatory medication • Women who have taken aspirin regularly in the 28 days prior to screening • A known major fetal anomaly that requires pregnancy termination • Currently participating in another drug trial • Unable or unwilling to provide informed consent. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 60 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 26/02/2024 University of Melbourne Human Research Ethics Committee STEMM 1 ethics committee
Ethics Committee Address
Street address City Postal code Country
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton The University of Melbourne, Victoria 3010, Australia Victoria 3010 Australia
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 16/02/2024 Kenyatta National Hospital University of Nairobi
Ethics Committee Address
Street address City Postal code Country
Off Ngong Road Nairobi 00202 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 08/03/2024 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
MB 190 Accra Digital Address GA 050 3303 Accra 050-3303 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 05/02/2024 University of Cape Town
Ethics Committee Address
Street address City Postal code Country
University of Cape Town Faculty of Health Sciences Human Research Ethics Committee Cape Town 53 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of birth at <37 weeks with pre-eclampsia (efficacy) and a composite measure of PPH-related treatment (safety) in women at high risk of pre-eclampsia according to a screening algorithm. At childbirth, fetal death or pre-eclampsia diagnosis, whichever occurs first
Secondary Outcome Clinical, process-of-care and cost-effectiveness outcomes At completion of follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ghana GP 4236 Accra Ghana
University of Nairobi Off Ngong Road Nairobi 2343 Kenya
University of Cape Town Old Main Building Groote Schuur Hospital Observatory, 7925 Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 Fifth Avenue North Seattle Washington 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Concept Foundation Batiment F2F3 Avenue de Secheron 15 1202 Geneva 1202 Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
University of Nairobi off Ngong Road Nairobi Kenya
Univrsity of Cape Town Accra Accra Ghana
Uinersity of Cape Town Cape Town Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joshua Vogel Joshua.vogel@burnet.edu.au +61392822111 85 Commercial Road
City Postal code Country Position/Affiliation
Melbourne 3004 Australia Professor
Role Name Email Phone Street address
Principal Investigator Metin Gulmezoglu gulmezoglum@conceptfoundation.org +41227342560 Batiment F2F3 Avenue de Secheron 15
City Postal code Country Position/Affiliation
Geneva 1202 Switzerland Professor
Role Name Email Phone Street address
Scientific Enquiries Joshua Vogel Joshua.vogel@burnet.edu.au +61392822111 85 Commercial Road
City Postal code Country Position/Affiliation
Melbourne 3004 Australia Professor
Role Name Email Phone Street address
Public Enquiries Joshua Vogel Joshua.vogel@burnet.edu.au +61481770067 85 Commercial Road
City Postal code Country Position/Affiliation
Mebourne 3004 Australia Professor
Role Name Email Phone Street address
Principal Investigator Zahida Qureshi zahida@qureshi.co.ke 254721310750 Off Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Professor and Country Principal Investigator
Role Name Email Phone Street address
Principal Investigator Samuel Opong saoppong@ug.edu.gh +233206301387 SAMUEL ANTWI OPPONG DEPARTMENT OF OBSTETRICS AND GYNECOLOGY UNIVERSITY OF GHANA MEDICAL SCHOOL 33 MATERNITY BLOCK GUGGISBURG AVENUE KORLE-BU ACCRA GHANA
City Postal code Country Position/Affiliation
Accra 4236 Ghana Professor and Country Principal Investigator
Role Name Email Phone Street address
Principal Investigator Sue Fawcus sue.fawcus@uct.ac.za +273354823 Department of Obstetrics and Gynaecology H45 Room 63 Old Main Building Groote Schuur Hospital Private Bag X4 Observatory Cape Town 7925
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Professor and Country Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes “In accordance with the Bil & Melinda Gates Open Access Policy, underling data collected for this study will be made available at time of publication of the main trial report. These data will be de-identified in order to protect participants privacy and confidentiality,” Informed Consent Form,Statistical Analysis Plan,Study Protocol “In accordance with the Bil & Melinda Gates Open Access Policy, underling data collected for this study will be made available at time of publication of the main trial report. These data will be de-identified in order to protect participants privacy and confidentiality,” NA
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