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

• Status: Terminated
• Trial end date: 2019-10-07
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Treatments: Aspirin; Calcium heparin; Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• Confirmed pregnancy;

• 18 years or older;

• Two or more unexplained pregnancy loss before the 10th week of gestation, AND/OR one or more unexplained pregnancy loss at or beyond the 10th week of gestation;

• One or more APS laboratory criteria present, according to the revised Sapporo criteria;

Exclusion Criteria:

• Greater than 11 weeks +6 days gestational age at time of randomization;

• Indication(s) for prophylactic or therapeutic-dose anticoagulation;

• Contraindication to heparin or aspirin;

• Received 7 or more doses of LMWH;

• Previous participation in the trial;

• Geographic inaccessibility;

• Refused consent.