drugset / Trial / NCT03100123

AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study

NCT03100123

Phase 0 Terminated 1 enrolled Ottawa Hospital Research Institute
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

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 81 mg Oral
Comparator Dalteparin sodium Other / unclassified
Comparator Enoxaparin sodium Other / unclassified
Comparator Tinzaparin Other / unclassified 4500 iu Subcutaneous