drugset / Trial / NCT06408181
APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
Phase 3
Recruiting
1150 enrolled
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The goal of this clinical trial is to investigate the effects of early initiation of double low-dose aspirin in pregnant women. The main questions it aims to answer are: Does this dose and timing of aspirin reduce the risk of pre-eclampsia compared to standard recommendations? Does this dose and timing of aspirin reduce the risk of pregnancy loss compared to standard recommendations? Participants will begin taking at no later than 6 weeks 6 days gestational age, either 162mg of aspirin through delivery or placebo until 12 weeks and then 81mg of aspirin through delivery.
Timeline
- Start
- 2024-06-12
- Primary completion
- 2029-06
- Completion
- 2029-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 81 mg | — |
| Comparator | Aspirin | Small molecule | 162 mg | — |