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
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Study Feasibility: Mean Recruitment Rate Per Center Per Month
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Standard of Care Arm
Open-label low-molecular-weight heparin (LMWH) prophylaxis until 37 weeks gestation AND low-dose aspirin daily until delivery.
干预措施: Low-molecular-weight heparin (Drug)
Experimental Arm
Open-label low-dose Aspirin 81 mg daily from randomization until delivery.
干预措施: Aspirin 81 mg (Drug)
结局指标
主要结局
Study Feasibility: Mean Recruitment Rate Per Center Per Month
时间窗: 24 months
The primary feasibility outcome of the pilot trial is the mean recruitment rate per center per month.
次要结局
- Crossover Rate(52 weeks)
- Eligibility(24 months)
- Consent(24 months)
- Study Drug Compliance(52 weeks)
- Essential Documents(18 months)
- Withdrawals/Loss to Follow-up(24 months)