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NCT Number: NCT03893630

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

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.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

Eligible women will be identified in the late first or early second trimesters. Once recruited, women will be randomly assigned to either 81 mg or 162 mg per day dosing schedules. The randomization scheme will vary based on the body mass index (BMI) with separate schemes for women <=30 kg/m2 versus >30 kg/m2. Ultrasonographic assessment of biophysical biomarkers will be obtained at 11-16 weeks, 18-22 weeks, and 28-32 weeks gestation. Biologic samples of serum and urine will be obtained at the 11-16 week and 28-32 week visit. Upon delivery, cord blood and a placental specimen will also be obtained. Medication treatment will continue until 36 weeks gestation. Pregnancy and neonatal outcome data will be recorded.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetylsalicylic Acid 81 mg

Drug

Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.

Other names: Aspirin

Acetylsalicylic Acid 162 mg

Drug

Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.

Other names: Aspirin

Control

Other

Standard of Care

Primary outcomes

  1. Change in Pulsatility Index (PI)

    Time frame: Three times between 11 and 32 weeks of gestation.

    Uterine artery doppler is used to assess impedance to flow in the uterine artery three times: 11-16 weeks gestation(baseline), 18-22 weeks gestation (event 2), 28-32 weeks gestation (event 3). Data reported as change between 11-16 weeks gestation (baseline) and either 18-22 weeks gestation (event 2) or 28-32 weeks gestation (event 3).

    difference in uterine artery pulsatility index (PI) is calculated as the difference in PI for each patient between each trimester visit. PI at each visit will be calculated by averaging left-side and right-side PIs from each of three (or all available) images on each side for each patient using ultrasound technology. Unit of measure is a ratio: difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity Relative change in uterine artery pulsatility index is a measure of flow to the uterus. A greater difference from the baseline value represents a greater improvement in placental perfusion.

Secondary outcomes

  1. Onset of Pre-eclampsia

    Time frame: From enrollment at 11 weeks throughout pregnancy and postpartum ( 6 weeks after delivery), approximately 35 weeks

    Frequency of Disease during pregnancy and postpartum as defined by American College of Obstetrics and Gynecology (ACOG) criteria

  2. Severity of Pre-eclampsia

    Time frame: From enrollment at 11 weeks throughout pregnancy and immediate postpartum ( 6 weeks after delivery), approximately 35 weeks

    Frequency women are identified with Severe Features of the disease

  3. Composite Neonatal Outcomes Including Frequency of Intraventricular Hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome (RDS), Necrotising Enterocolitis(NEC)

    Time frame: Neonatal period ( first 28 days after birth)

    Frequency of adverse neonatal outcomes

  4. Change in s-ICAM Levels Over Time

    Time frame: Three times between 11 and 32 weeks of gestation

    Serial biologic samples will be obtained in the first (baseline), second (event 2), and third (event 3) trimesters to measure changes in soluble Intercellular Adhesion Molecule (s-ICAM) levels over time.

  5. Change in PIGF Levels Over Time

    Time frame: Three times between 11 and 32 weeks of gestation

    Serial biologic samples will be obtained in the first (baseline), second (event 2), and third (event 3) trimesters to measure changes in placental growth factor (PIGF) levels over time.

  6. Change in CRP Levels Over Time

    Time frame: Three times between 11 and 32 weeks of gestation

    Serial biologic samples will be obtained in the first, second, and third trimesters to measure changes in C-reactive protein (CRP) levels over time.

  7. Change in IL-6 Over Time

    Time frame: Three times between 11 and 32 weeks of gestation

    Serial biologic samples will be obtained in the first, second, and third trimesters to measure changes in interleukin 6 (IL-6) levels over time.

  8. Change in TNF Over Time

    Time frame: Three times between 11 and 32 weeks of gestation

    Serial biologic samples will be obtained in the first, second, and third trimesters to measure changes in tumor necrosis factor (TNFα) levels over time.

  9. Gestational Age at Delivery

    Time frame: At Delivery, up to 41 weeks

    measured in weeks, from the first day of the last menstrual cycle to delivery

Sponsors and collaborators

Lead sponsor

John O'Brien, MD

Other

Registry information

Official study title

Role of Aspirin in Maternal Endothelial Dysfunction and Uterine Artery Blood Flow in Women at Risk for Preeclampsia

Acronym: ASPERIN

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2019
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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