drugset / Trial / NCT03100123
AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study
RandomizedParallel-groupOpen-labelTreatment
Summary
The APPLE pilot trial is a feasibility study that is a multicentre, open-label, randomized controlled trial. Pregnant women with antiphospholipid syndrome (APS) and a history of late (≥10 weeks gestation) or recurrent early (2 \<10 weeks) pregnancy loss will be recruited. Eligible and consenting subjects will be assigned to one of two study arms: open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin (ASA) daily until delivery, or open-label low-dose aspirin daily from randomization until delivery.
Timeline
- Start
- 2017-11-06
- Primary completion
- 2019-10-07
- Completion
- 2019-10-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 81 mg | Oral |
| Comparator | Dalteparin sodium | Other / unclassified | — | — |
| Comparator | Enoxaparin sodium | Other / unclassified | — | — |
| Comparator | Tinzaparin | Other / unclassified | 4500 iu | Subcutaneous |