Aspirin (ASA) Therapy and Preeclampsia Prevention
Withdrawn before enrolling · Phase 4
Conditions studied: Preeclampsia
In brief
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.
Key facts
- Study ID
- NCT04158830
- Run by
- University of Tennessee
- People needed
- 0
- Starts
- 2020-06-01
- Expected to finish
- 2021-11-30
- Last updated by the study team
- 2020-11-13
Who can join
Age: 14 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Regional One Health, Obstetrics Outpatient Clinic — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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