Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aspirin (ASA) Therapy and Preeclampsia Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158830
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:

According to U.S. Pharmacist® "low-dose aspirin refers to dosages between 81 mg and 325 mg taken every day to prevent heart attacks, strokes, and colon cancer." It has been found through research that low-dose aspirin also decreases the risk of preeclampsia. The American College of Obstetrics and Gynecologists (ACOG) recommends low-dose aspirin (81mg/day) for women at high risk of preeclampsia. However, some researchers report that a dose of aspirin < 100 mg/day does not seem to decrease the risk of preeclampsia. Another trial studying patients who are at a high risk for preterm preeclampsia, reported a reduction in the occurrence of preeclampsia among patients taking aspirin at a dose of 150 mg.

The purpose of this pragmatic randomized study is to compare the difference in the effectiveness of two doses of aspirin: 81 mg versus 162 mg in the prevention of preeclampsia in pregnant women who are at a moderate to high risk for developing preeclampsia.


Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Aspirin 81 mg Enteric Coated Tab - 1 tablet Drug: Aspirin 81 mg Enteric Coated Tab - 2 tablets Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Subjects will be randomized in consecutive order, entering their basic information (name, date of birth, medical record number, date/time of randomization, randomization number) on a master log.

Group 1- (total of up to 450 subjects) designated by odd numbers in the randomization pattern [1-001, 1-003, 1-005, etc. to 899] oral dose: 81 mg aspirin daily: Rx 81 mg ASA, 1 tablet daily (1 bottle of 200 tablets/patient)

Group 2-(total of up to 450 subjects) designated by even numbers in the randomization pattern [2-002, 2-004, 2-006, etc. to 900] oral dose: 162 mg aspirin daily: Rx 81 mg ASA, 2 tablets daily (1 bottle of 400 tablets/patient)

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pragmatic Randomized Study Comparing 81 mg Aspirin Versus 162 mg Aspirin in the Prevention of Preeclampsia During Pregnancy
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Group 1 - ACOG recommended dose
oral dose: 81 mg aspirin daily; designated by odd number assignment [1-001, 1-003, 1-005, etc. to 899]
Drug: Aspirin 81 mg Enteric Coated Tab - 1 tablet
take one (1) 81 mg tablet each evening
Other Name: Group 1 - ACOG recommended dose

Active Comparator: Group 2 - Comparison Dose
oral dose: 162 mg aspirin daily; designated by even number assignment [2-002, 2-004, 2-006, etc. to 900]
Drug: Aspirin 81 mg Enteric Coated Tab - 2 tablets
take two (2) 81 mg tablets each evening
Other Name: Group 2 - Comparison Dose




Primary Outcome Measures :
  1. Preeclampsia [ Time Frame: approximately 30 weeks; from 12 weeks gestation until the day of delivery ]
    Occurrence of preeclampsia: categorized as - none, preterm, or term



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women only
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant females ages 14 to 50 years old
  • Up to 28.0 weeks gestation (may initially base on last menstrual period (LMP), but confirmed with ultrasound (US)
  • Be at high risk or moderate risk for developing preeclampsia as defined by the American College of Obstetrics and Gynecologists (ACOG-2018), the Society for Maternal-Fetal Medicine (SMFM-2018), and the United States Preventive Services Task Force (USPSTF-2017)

Exclusion Criteria:

  • Less than 14 years old or greater than 50 years old
  • Allergy or contraindication to taking aspirin (i.e. nasal polyps, asthma with aspirin-induced bronchoconstriction)
  • History of gastrointestinal bleeding
  • Active peptic ulcer disease
  • Other sources of active Gastrointestinal/Genitourinary bleeding
  • Physician or provider refusal
  • Patient refusal
  • History of bleeding or clotting disorder (i.e. Factor V, von Willebrand, hemophilia)
  • Severe renal failure (Glomerular Filtration Rate < 10 ml/min)
  • Taking aspirin prior to pregnancy

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): NCT04158830


Contacts
Layout table for location contacts
Contact: Annette B. Hickerson, RN, CCRC 901-448-4784 abpayne@uthsc.edu
Contact: Chelsea M. Walley, RN, BSN 901-448-4784 cmcgeewa@uthsc.edu

Locations
Layout table for location information
United States, Tennessee
Regional One Health, Obstetrics Outpatient Clinic
Memphis, Tennessee, United States, 38103
Contact: Annette B. Hickerson, RN, CCRC    901-448-4784    abpayne@uthsc.edu   
Contact: Chelsea M. Walley, RN, BSN    901-448-4784    cmcgeewa@uthsc.edu   
Principal Investigator: Giancarlo Mari, MD, FACOG         
Sponsors and Collaborators
University of Tennessee
Investigators
Layout table for investigator information
Principal Investigator: Giancarlo Mari, MD, FACOG OB/ GYN Department Professor and Chair
Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT04158830    
Other Study ID Numbers: 19-06959-FB
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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.: No
Keywords provided by University of Tennessee:
prevention
aspirin therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
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