APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
- Conditions
- Pre-EclampsiaPregnancy Loss
- Interventions
- Registration Number
- NCT06408181
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double low-dose aspirin Aspirin 162 mg Participants will take 2 81mg aspirin tablets daily from entrance into the trial until delivery. Standard of Care Aspirin 81mg 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.
- Primary Outcome Measures
Name Time Method Preeclampsia with or without severe features 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 from enrollment to time of pregnancy loss, up to 24 weeks gestation Pregnancy loss prior to 24 weeks gestation
- Secondary Outcome Measures
Name Time Method Gestational Hypertension From 20 weeks of pregnancy to delivery, approximately 20 weeks Defined as two BPs ≥ 140/90 mmHg at least 4 hours apart without proteinuria
Preeclampsia without severe features From 20 weeks of pregnancy to delivery, up to 20 weeks 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.
Clinical pregnancy loss From time of first ultrasound to 20 weeks pregnancy Defined as any pregnancy loss occurring following ultrasound confirmation of pregnancy
Composite outcome of hypertensive disorders of pregnancy or pregnancy loss From enrollment to end of pregnancy, up to 38 weeks 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
Preterm preeclampsia From enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy Diagnosis of preterm preeclampsia, occurring prior to 37 weeks in pregnancy
Term preeclampsia From 37 weeks until delivery, up to 3 weeks Diagnosis of term preeclampsia, occurring at 37 weeks or later in pregnancy
Preeclampsia with severe features From 20 weeks of pregnancy to delivery, up to 20 weeks Diagnosis of preeclampsia with severe hypertension and/or specific signs or symptoms of significant end-organ dysfunction
Biochemical pregnancy loss From enrollment to time of pregnancy loss, up to approximately 20 weeks Defined as losses that occur prior to identification of a gestational sac via ultrasound
Preterm birth From enrollment to 36 weeks 6 days of pregnancy, up to delivery Defined as delivery at less than 37 weeks gestation
Small for gestational age At time of delivery Defined as a birth weight less than 10th percentile for gestational age
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States