TerminatedEarly Phase 1

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

Stopped: Pilot deemed not feasible by Steering Committee due to recruitment rate.

Canada1 participantsStarted 2017-11-06

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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.

What they're measuring

Study Feasibility: Mean Recruitment Rate Per Center Per Month

Timeframe: 24 months

Trial details

NCT IDNCT03100123

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-07

Results submitted2020-03-25