Aspirin (ASA) Therapy and Preeclampsia Prevention

• Status: Withdrawn
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Tennessee
• Treatments: Aspirin

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