APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,150
- 试验地点
- 2
- 主要终点
- Preeclampsia with or without severe features
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of early initiation of double low-dose aspirin in pregnant women. The main questions it aims to answer are:
Does this dose and timing of aspirin reduce the risk of pre-eclampsia compared to standard recommendations? Does this dose and timing of aspirin reduce the risk of pregnancy loss compared to standard recommendations? Participants will begin taking at no later than 6 weeks 6 days gestational age, either 162mg of aspirin through delivery or placebo until 12 weeks and then 81mg of aspirin through delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Ability to take oral medication and be willing to adhere to the prescribed aspirin regimen.
- •Patients with a gestation less than or equal to 6 weeks, 6 days (as determined by patient record of LMP or ART date).
- •Patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including:
- •preeclampsia in a previous pregnancy,
- •gestational diabetes in a previous pregnancy,
- •any documentation of fetal growth restriction or low birth weight in a prior pregnancy,
- •preterm birth in a previous pregnancy,
- •known multifetal gestation at enrollment,
- •chronic hypertension,
- •pregestational diabetes,
- •kidney disease,
- •systemic lupus erythematosus,
- •nulliparity,
- •pre-pregnancy body mass index >30,
- •family history of preeclampsia (i.e., mother or sister),
- •Black persons (due to social, not biological reasons),
- •Maternal age 35 years or older,
- •lower income (will be determined by qualification of public health insurance),
- •conceived with fertility treatment (including in vitro fertilization, ovulation induction, or intrauterine insemination),
- •history of one or more prior pregnancy losses <20 weeks gestation,
- •history of stillbirth in a prior pregnancy,
- •An interval of greater than 10 years since the last pregnancy.
排除标准
- •Known allergies to aspirin. Exclusion to allergies to other non-steroidal anti-inflammatory agents (NSAID) will be determined on a case-by-case basis;
- •Clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia;
- •Clinical indication for chronic use of NSAIDS during pregnancy;
- •Medical contraindication to aspirin therapy, including untreated uncontrolled asthma, untreated symptomatic nasal polyps, bleeding disorders, or history of gastrointestinal ulcer.
- •Patients with pelvic pain or bleeding who require urgent care (i.e., active vaginal bleeding greater than or equal to expected menses, open cervical os suggesting active miscarriage or severe pain requiring evaluation for ectopic pregnancy)
研究组 & 干预措施
Double low-dose aspirin
Participants will take 2 81mg aspirin tablets daily from entrance into the trial until delivery.
干预措施: Aspirin 162 mg (Drug)
Standard of Care
Participants will take 2 placebo pills from entrance into the study until 12 weeks gestational age, they will then take 1 placebo pill and 1 81mg aspirin until delivery.
干预措施: Aspirin 81mg (Drug)
结局指标
主要结局
Preeclampsia with or without severe features
时间窗: from 20 weeks pregnancy to delivery, approximately 20 weeks
defined as two blood pressures (BPs) ≥ 140/90 mmHg at least 4 hours apart with proteinuria
Pregnancy Loss
时间窗: from enrollment to time of pregnancy loss, up to 24 weeks gestation
Pregnancy loss prior to 24 weeks gestation
次要结局
- Term preeclampsia(From 37 weeks until delivery, up to 3 weeks)
- Gestational Hypertension(From 20 weeks of pregnancy to delivery, approximately 20 weeks)
- Preeclampsia without severe features(From 20 weeks of pregnancy to delivery, up to 20 weeks)
- Clinical pregnancy loss(From time of first ultrasound to 20 weeks pregnancy)
- Composite outcome of hypertensive disorders of pregnancy or pregnancy loss(From enrollment to end of pregnancy, up to 38 weeks)
- Preterm preeclampsia(From enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy)
- Preeclampsia with severe features(From 20 weeks of pregnancy to delivery, up to 20 weeks)
- Biochemical pregnancy loss(From enrollment to time of pregnancy loss, up to approximately 20 weeks)
- Preterm birth(From enrollment to 36 weeks 6 days of pregnancy, up to delivery)
- Small for gestational age(At time of delivery)