Recruiting
Phase 3

Aspirin

Sponsor:

University of Pennsylvania

Code:

NCT06408181

Conditions

Pre-Eclampsia

Pregnancy Loss

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Aspirin 162 mg

Aspirin 81mg

Study Details

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.

Conditions

Pre-Eclampsia

Pregnancy Loss

Study ID

NCT06408181

Start date

Jun 12, 2024

Status verified date

Jan, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Ability to take oral medication and be willing to adhere to the prescribed aspirin regimen.
4. Patients with a gestation less than or equal to 6 weeks, 6 days (as determined by patient record of LMP or ART date).
5. Patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including:

1. preeclampsia in a previous pregnancy,
2. gestational diabetes in a previous pregnancy,
3. any documentation of fetal growth restriction or low birth weight in a prior pregnancy,
4. preterm birth in a previous pregnancy,
5. known multifetal gestation at enrollment,
6. chronic hypertension,
7. pregestational diabetes,
8. kidney disease,
9. systemic lupus erythematosus,
10. nulliparity,
11. pre-pregnancy body mass index >30,
12. family history of preeclampsia (i.e., mother or sister),
13. Black persons (due to social, not biological reasons),
14. Maternal age 35 years or older,
15. lower income (will be determined by qualification of public health insurance),
16. conceived with fertility treatment (including in vitro fertilization, ovulation induction, or intrauterine insemination),
17. history of one or more prior pregnancy losses <20 weeks gestation,
18. history of stillbirth in a prior pregnancy,
19. An interval of greater than 10 years since the last pregnancy.

Exclusion Criteria

1. Known allergies to aspirin or non-steroidal anti-inflammatory agents (NSAID);
2. Clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia;
3. Clinical indication for chronic use of NSAIDS during pregnancy;
4. Medical contraindication to aspirin therapy, including untreated uncontrolled asthma, untreated symptomatic nasal polyps, bleeding disorders, or history of gastrointestinal ulcer.
5. 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)

Study Design

Enrollment

1150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Double low-dose aspirin

Participants will take 2 81mg aspirin tablets daily from entrance into the trial until delivery.

placebo comparator: 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.

Interventions

Aspirin 162 mg

Aspirin is a nonsteroidal anti-inflammatory drug.

Aspirin 81mg

Aspirin is a nonsteroidal anti-inflammatory drug.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

University of Pennsylvania

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-01-20.