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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,150
Aspirin is a nonsteroidal anti-inflammatory drug.
Aspirin is a nonsteroidal anti-inflammatory drug.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGPreeclampsia with or without severe features
defined as two blood pressures (BPs) ≥ 140/90 mmHg at least 4 hours apart with proteinuria
Time frame: from 20 weeks pregnancy to delivery, approximately 20 weeks
Pregnancy Loss
Pregnancy loss prior to 24 weeks gestation
Time frame: from enrollment to time of pregnancy loss, up to 24 weeks gestation
Composite outcome of hypertensive disorders of pregnancy or pregnancy loss
This composite outcome will include the diagnosis of any of the following: preterm preeclampsia, term preeclampsia, gestational hypertension, preeclampsia with severe features, preeclampsia without severe features, biochemical pregnancy loss, clinical pregnancy loss
Time frame: From enrollment to end of pregnancy, up to 38 weeks
Preterm preeclampsia
Diagnosis of preterm preeclampsia, occurring prior to 37 weeks in pregnancy
Time frame: From enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy
Term preeclampsia
Diagnosis of term preeclampsia, occurring at 37 weeks or later in pregnancy
Time frame: From 37 weeks until delivery, up to 3 weeks
Gestational Hypertension
Defined as two BPs ≥ 140/90 mmHg at least 4 hours apart without proteinuria
Time frame: From 20 weeks of pregnancy to delivery, approximately 20 weeks
Preeclampsia with severe features
Diagnosis of preeclampsia with severe hypertension and/or specific signs or symptoms of significant end-organ dysfunction
Time frame: From 20 weeks of pregnancy to delivery, up to 20 weeks
Preeclampsia without severe features
defined as two BPs ≥160/110 mmHg at least 4 hours apart or any of the following lab abnormalities or symptoms: platelets \<100,000/microliter, liver enzymes at least twice the normal concentration, and/or severe right upper quadrant/epigastric pain, serum creatinine \> 1.1 mg/dL or a doubling of baseline serum creatinine, pulmonary edema, or new-onset cerebral or visual disturbances (headache, blurry vision). Preeclampsia super-imposed on chronic hypertension will also be considered as part of this outcome.
Time frame: From 20 weeks of pregnancy to delivery, up to 20 weeks
Biochemical pregnancy loss
Defined as losses that occur prior to identification of a gestational sac via ultrasound
Time frame: From enrollment to time of pregnancy loss, up to approximately 20 weeks
Clinical pregnancy loss
Defined as any pregnancy loss occurring following ultrasound confirmation of pregnancy
Time frame: From time of first ultrasound to 20 weeks pregnancy
Preterm birth
Defined as delivery at less than 37 weeks gestation
Time frame: From enrollment to 36 weeks 6 days of pregnancy, up to delivery
Small for gestational age
Defined as a birth weight less than 10th percentile for gestational age
Time frame: At time of delivery
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