Pregnancy and Childbirth
Conditions
Interventions
Daily oral aspirin 150mg
Daily oral aspirin 75mg
Sponsors
Concept Foundation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical, process-of-care and cost-effectiveness outcomes | — |
Countries
Ghana, Kenya, South Africa
Contacts
Public ContactJoshua Vogel
Professor
Outcome results
None listed