Pregnancy Loss Clinical Trial
Official title:
A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin Versus Low-molecular-weight Heparin (LMWH) and Aspirin in Women With Antiphospholipid Syndrome and Pregnancy Loss
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.
The purpose of this pilot trial is to determine the feasibility of conducting a multicenter
randomized full trial evaluating antepartum prophylaxis with ASA versus LMWH/ASA in women
with confirmed APS and a history of late or recurrent early pregnancy loss.
Given the large sample size needed to adequately power a large multicenter trial that
assesses the efficacy of ASA alone versus LMWH/ASA, the investigators first need to determine
if it is possible to meet minimum recruitment rates needed for a full multicenter trial. If
the pilot feasibility trial is successful, then the secondary outcomes collected will be used
in the analysis of the full multicenter trial.
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