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Phase 2 N=208 Randomized Prevention

Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia

Pre-Eclampsia

Enrolled (actual)
208
Serious AEs
16.8%
Results posted
Aug 2025
Primary outcome: Primary: Change in Pulsatility Index (PI) — -0.56; -0.53; -0.43; -0.88 ratio

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Acetylsalicylic Acid 81 mg (Drug); Acetylsalicylic Acid 162 mg (Drug); Control (Other)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
John O'Brien, MD
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Pulsatility Index (PI)
-0.56; -0.53; -0.43; -0.88; -0.72; -0.58
SECONDARY
Onset of Pre-eclampsia
1; 8; 13
SECONDARY
Severity of Pre-eclampsia
0; 0; 0
SECONDARY
Composite Neonatal Outcomes Including Frequency of Intraventricular Hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome (RDS), Necrotising Enterocolitis(NEC)
5; 17; 21
SECONDARY
Change in s-ICAM Levels Over Time
6.1; 1.6; 7.9; -29.6; -43.6; -34.1
SECONDARY
Change in PIGF Levels Over Time
570.6; 568.3; 509.7; -36.4; 1.0; -16.7
SECONDARY
Change in CRP Levels Over Time
-0.5; 0.2; -2.7; -10.6; -13.4; -11.9
SECONDARY
Change in IL-6 Over Time
SECONDARY
Change in TNF Over Time
SECONDARY
Gestational Age at Delivery
38.8; 36.0; 36.2

Summary

Endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. In preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. However, studies have shown that acetylsalicylic acid (Aspirin) can decrease endothelial dysfunction leading to decreased platelet aggregation which reduces adverse outcomes. The objective of our study is to determine if Aspirin has a dose-dependent response for modifying biomarkers reflective of maternal endothelial dysfunction when indicated for preeclampsia prevention in a cohort of women identified at risk for developing preeclampsia. Pregnant women who are at risk for preeclampsia will be randomized to receive either 81mg Aspirin or 162mg Aspirin daily starting from 11-16 weeks of gestation until 36 weeks of gestation. A third, control group of women at low risk for preeclampsia will not receive aspirin. All women will be assessed with uterine artery Doppler studies and mean arterial blood pressures at three time points during pregnancy. Blood, urine, and cord blood samples will also be collected.

Eligibility Criteria

Inclusion Criteria (control)

  • No risk factors for preeclampsia

Inclusion Criteria (pre-eclampsia)

  • History of preterm preeclampsia
  • Chronic hypertension
  • Type 1 and Type 2 diabetes
  • Renal diseases
  • Autoimmune disease

Exclusion Criteria

  • Pregnant women younger than 18 years or older than 45 years
  • Multiple gestations
  • History of allergy (urticaria or anaphylaxis) to aspirin or aspirin-related products asthma that worsens after aspirin use
  • Patients with gastrointestinal or genitourinary bleeding
  • Patients with peptic ulcer disease
  • Patients with severe liver dysfunction
  • Patients who have undergone bypass surgery
  • Patients on anticoagulant medication(s)
  • Women with anomalous fetus
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03893630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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