None listed
Conditions
Brief summary
A multi-country, multi-centre, randomised trial in Ghana, Kenya and South Africa, comparing efficacy and safety of two doses of aspirin to prevent pre-eclampsia in women at increased risk pre-eclampsia. An online clinical decision support tool will be used to screen pregnant women for risk of pre-eclampsia in participating sites. Women identified as high risk and who are otherwise eligible will be invited to provide informed consent for a randomised trial of 75mg or 150 mg/day of aspirin. The trial will assess the effects of different aspirin doses on preventing preterm pre-eclampsia. We will also assess whether aspirin dosing affects management of postpartum haemorrhage. Through this study, this international collaboration will generate critical evidence to align clinical guidelines globally on the optimal dose of aspirin for the prevention of pre-eclampsia.
Interventions
Aspirin (acetylsalicylic acid).
The intervention regimen is daily oral aspirin 150mg once daily (nocte) from time of recruitment (11 to <20 weeks’ gestation) until 36 weeks’ gestation, childbirth, fetal death or pre-eclampsia is diagnosed, whichever occurs first.
Adherence to aspirin allocation will be measured based on the number of tablets (intervention or control) that were taken, divided by the number of tablets the woman was eligible for.
Sponsors
Concept Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
• Pregnant women (and their fetus/es) from 11 weeks to <20 weeks’ gestation, identified as being at high risk of pre-eclampsia, according to the restricted-variable Fetal Medicine Foundation (FMF) algorithm combining maternal history and mean arterial pressure (MAP) In addition, women with known multi-fetal pregnancy or with known sickle-cell disease at screening will be considered as automatic high risk and will be eligible for the trial. These women will still undergo screening with the restricted variable FMF tool, to collect baseline information. • Women intend to give birth in a participating study facility/care network
Exclusion criteria
• Women identified by restricted-variable FMF screening algorithm as low risk • Women with a known non-viable pregnancy at recruitment • 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 • 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 at recruitment • Currently participating in another drug trial • Unable or unwilling to provide informed consent.
Outcome results
None listed