A Phase 3 interventional study of Aspirin 162 mg and Aspirin 81mg in Pre-Eclampsia and Pregnancy Loss, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University of Pennsylvania · Phase 3, Interventional, and Prevention
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 1,150 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will take 2 81mg aspirin tablets daily from entrance into the trial until delivery.
Drug: Aspirin 162 mg
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.
Drug: Aspirin 81mg
Aspirin is a nonsteroidal anti-inflammatory drug.
Also known as: acetylsalicylic acid, ASA
Aspirin is a nonsteroidal anti-inflammatory drug.
Also known as: acetylsalicylic acid, ASA
Preeclampsia 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
Started Jun 2024 (actual). Primary completion is estimated for Jun 2029, 60 months after the start.
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Studies of the drug tested here: Aspirin