Recruiting
Phase 1
Phase 2

Aspirin in Pregnancy

Sponsor:

Thomas Jefferson University

Code:

NCT06826859

Conditions

Preterm Birth

Preeclampsia

Eligibility Criteria

Sex: Female

Age: 16 - 55

Healthy Volunteers: Not accepted

Interventions

Daily aspirin (ASA)

Split dose aspirin (ASA)

Study Details

Brief summary:

Aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.

Conditions

Preterm Birth

Preeclampsia

Study ID

NCT06826859

Start date

Jun 26, 2025

Status verified date

Jul, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Singleton gestation gestational age <16 0/7 weeks, dating confirmed with ultrasound
  • ≥1 high risk factor for preeclampsia or ≥2 moderate risk factors as per United States Preventative Services Task Force (2021)
  • Recommendation for 162mg aspirin daily in pregnancy
  • Age 16-55 years old

Exclusion criteria

  • Contraindication to aspirin
  • Current or planned use of any other anticoagulation
  • Thrombocytopenia, other known platelet or bleeding disorder
  • Abnormally elevated baseline PFA-100 epinephrine closure time prior to aspirin initiation

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Daily aspirin

162mg aspirin daily

experimental: Split dose aspirin

81mg aspirin q12 hours

Interventions

Daily aspirin (ASA)

162mg aspirin taken daily

Split dose aspirin (ASA)

81mg aspirin q12hours

Primary outcome measure

  • Aspirin Response PFA-100 epinephrine closure time (seconds) [ Time Frame: 2-4 weeks after aspirin initiation ]

Central Contacts and Locations

Central contacts

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19060

Contacts

Principal Investigator:

Rupsa C Boelig, MD

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Keywords

  • Aspirin
  • Preeclampsia
  • Preterm birth
  • Pregnancy
  • Pharmacokinetics
  • Pharmacodynamics
  • Phase I/II
  • Randomized clinical trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-07-17.