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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Aspirin 81 mg po daily in tablet form.
The LMWH regime will be at the discretion of the treating physician, with a suggested regime as follows: tinzaparin 4,500 IU sc daily until 20 weeks gestation, and then 4,500 IU sc twice daily until 37 weeks gestation.
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Study Feasibility: Mean Recruitment Rate Per Center Per Month
The primary feasibility outcome of the pilot trial is the mean recruitment rate per center per month.
Time frame: 24 months
Essential Documents
Proportion of sites requiring \>18 months to obtain all required approvals/contracts from time of delivery of all study documents.
Time frame: 18 months
Eligibility
Proportion of screened patients who meet eligibility criteria (i.e. patients who meet inclusion criteria and are also eligible based on exclusion criteria).
Time frame: 24 months
Consent
Proportion of eligible subjects who provide consent.
Time frame: 24 months
Withdrawals/Loss to Follow-up
Proportion of withdrawals/loss to follow-up among randomized patients.
Time frame: 24 months
Crossover Rate
Crossover rate between standard of care and experimental study arms.
Time frame: 52 weeks
Study Drug Compliance
Level of compliance with study drug through patient recall and patient medication diary.
Time frame: 52 weeks
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