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Trial record 38 of 56 for:    severe preeclampsia AND weeks of gestation

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

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ClinicalTrials.gov Identifier: NCT03893630
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
John O'Brien, MD, University of Kentucky

Brief 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.


Condition or disease Intervention/treatment Phase
Pre-Eclampsia Drug: Acetylsalicylic Acid 81 mg Drug: Acetylsalicylic Acid 162 mg Other: Control Phase 2

Detailed Description:
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 11-13 weeks, 18-22 weeks, and 28-32 weeks gestation. Biologic samples of serum and urine will be obtained at the same intervals. Medication treatment will continue until 36 weeks gestation. Pregnancy and neonatal outcome data will be recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of Aspirin in Maternal Endothelial Dysfunction and Uterine Artery Blood Flow in Women at Risk for Preeclampsia
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Control Group
Patients will receive standard of care.
Other: Control
Standard of Care

Experimental: Acetylsalicylic Acid 81mg
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Drug: Acetylsalicylic Acid 81 mg
Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
Other Name: Aspirin

Experimental: Acetylsalicylic Acid 162mg
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Drug: Acetylsalicylic Acid 162 mg
Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
Other Name: Aspirin




Primary Outcome Measures :
  1. Change in Pulsatility Index (PI) [ Time Frame: Three times between 11 and 32 weeks of gestation. ]
    Uterine artery doppler will be used to assess impedance to flow in the uterine artery three times: at 11-16 weeks gestation, 18-22 weeks gestation, and 28-32 weeks gestation.


Secondary Outcome Measures :
  1. Onset of Pre-eclampsia [ Time Frame: Throughout pregnancy and postpartum ( 6 weeks after delivery) ]
    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: Throughout pregnancy and immediate postpartum ( 6 weeks after delivery) ]
    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, second, and third 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, second, and third 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893630


Contacts
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Contact: Aarthi Srinivasan, MD, MS 8592180765 asr224@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: John M O'Brien, MD    859-218-0765    john.obrien2@uky.edu   
Sponsors and Collaborators
John O'Brien, MD
Investigators
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Principal Investigator: John M O'Brien, MD University of Kentucky

Publications:
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Responsible Party: John O'Brien, MD, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03893630     History of Changes
Other Study ID Numbers: 47841
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by John O'Brien, MD, University of Kentucky:
aspirin
pulsatility index
doppler
uterine
acetylsalicylic acid
preeclampsia
blood pressure
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics