APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Обзор

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.

Вмешательства

• Препарат Aspirin 162 mg
  Aspirin is a nonsteroidal anti-inflammatory drug.
• Препарат Aspirin 81mg
  Aspirin is a nonsteroidal anti-inflammatory drug.

Первичные конечные точки

• Preeclampsia with or without severe features [Срок оценки: from 20 weeks pregnancy to delivery, approximately 20 weeks]
• Pregnancy Loss [Срок оценки: from enrollment to time of pregnancy loss, up to 24 weeks gestation]

Вторичные конечные точки (10)

• Composite outcome of hypertensive disorders of pregnancy or pregnancy loss [Срок оценки: From enrollment to end of pregnancy, up to 38 weeks]
• Preterm preeclampsia [Срок оценки: From enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy]
• Term preeclampsia [Срок оценки: From 37 weeks until delivery, up to 3 weeks]
• Gestational Hypertension [Срок оценки: From 20 weeks of pregnancy to delivery, approximately 20 weeks]
• Preeclampsia with severe features [Срок оценки: From 20 weeks of pregnancy to delivery, up to 20 weeks]
• Preeclampsia without severe features [Срок оценки: From 20 weeks of pregnancy to delivery, up to 20 weeks]
• Biochemical pregnancy loss [Срок оценки: From enrollment to time of pregnancy loss, up to approximately 20 weeks]
• Clinical pregnancy loss [Срок оценки: From time of first ultrasound to 20 weeks pregnancy]
• Preterm birth [Срок оценки: From enrollment to 36 weeks 6 days of pregnancy, up to delivery]
• Small for gestational age [Срок оценки: At time of delivery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Known allergies to aspirin or non-steroidal anti-inflammatory agents (NSAID);
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT06408181 · 854886 · 1R01HD112308-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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