Clinical Trial: AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
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
Brief 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.
Detailed Summary:
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.
Sponsor: Ottawa Hospital Research Institute
Current Primary Outcome: Feasibility [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Essential Documents [ Time Frame: 18 months ]Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents.
- Eligibility [ Time Frame: 24 months ]Proportion of screened patients who meet eligibility criteria (i.e. patients who meet inclusion criteria and are also eligible based on exclusion criteria).
- Consent [ Time Frame: 24 months ]Proportion of eligible subjects who provide consent.
- Withdrawals/Loss to Follow-up [ Time Frame: 24 months ]Proportion of withdrawals/loss to follow-up among randomized patients.
- Crossover Rate [ Time Frame: 52 weeks ]Crossover rate between standard of care and experimental study arms.
- Study Drug Compliance [ Time Frame: 52 weeks ]Level of compliance with study drug through patient recall and patient medication diary.
- Non-consent [ Time Frame: 24 months ]Reasons for physician and patient non-consent.
Original Secondary Outcome: Same as current
Information By: Ottawa Hospital Research Institute
Dates:
Date Received: February 21, 2017
Date Started: April 2017
Date Completion: July 2019
Last Updated: March 28, 2017
Last Verified: March 2017