NCT05514847Active, not recruitingPhase 4
Low Dose Aspirin for Preterm Preeclampsia Preventionmg/day Dose in High-risk Patients
Low Dose Aspirin for Preterm Preeclampsia Prevention - a Randomized Trial of 81 Vs 162 Mg/day Dose in High-risk Patients
Source: ClinicalTrials.gov · Last updated 15 Jan 2025
Brief summary (registry, in English)
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 16 Aug 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Virginia
- NCT number
- NCT05514847
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 1 Oct 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- ASA allergy, known hypersensitivity to NSAIDS
- Active peptic ulcer disease
- History of GI bleeding
Age
- Age \< 18
Other
- Patients with nasal polyps
- Patients with aspirin-induced asthma exacerbations
- Severe hepatic dysfunction
- Pregnancy with major abnormalities demonstrated on the 11-13-week scan
- Patient presents beyond 13w6d for first prenatal visit
- Non-viable pregnancy
Who the study is looking for
- Provision of signed and dated informed consent form
- Ages 18-50
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Pregnant female in the first trimester.
- Ability to take oral medication and be willing to adhere to the aspirin regimen
- Patient has a prenatal ultrasound between 11+0 through 13+6 days of gestation
- Patient who has low or high risks for preeclampsia by the ACOG (American College of Obstetricians and Gynecologists) screening tool, and low or high risks for the FMF prescreening tool for preeclampsia.
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.