Clinical trial NCT03100123: AntiPhospholipid Syndrome Low-molecular-weight Heparin Pregnancy Loss Evaluation: The Pilot Study
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Antiphospholipid Syndrome in Pregnancy
Pregnancy Loss
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible and consenting subjects will be assigned to one of two study arms. Randomization is stratified by 'high-risk' or 'non-high risk' laboratory criteria and the timing of pregnancy loss (late loss or no late loss).
Primary purpose: TREATMENT

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 description: 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.

Eligibility 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.

Primary outcomes:
measure: Study Feasibility: Mean Recruitment Rate Per Center Per Month
timeFrame: 24 months
Secondary outcomes:
measure: Essential Documents
timeFrame: 18 months
measure: Eligibility
timeFrame: 24 months
measure: Consent
timeFrame: 24 months
measure: Withdrawals/Loss to Follow-up
timeFrame: 24 months
measure: Crossover Rate
timeFrame: 52 weeks
measure: Study Drug Compliance
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Marc Rodger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Leslie Skeith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.