Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Medication Adherence
- Preeclampsia
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients are randomized to receiving aspirin knowing their risk status vs those who are randomized to universal receipt.Masking: Single (Outcomes Assessor)Masking Description: The study personnel who will perform pill counts will be masked to the study arm.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Research objective- To compare adherence to low dose, 81mg of aspirin in women considered high risk by USPSTF criteria vs universal receipt. Hypothesis: Women considered high risk by USPSTF criteria will have better adherence to low dose aspirin than women randomized to universal receipt. Study Desi...
Research objective- To compare adherence to low dose, 81mg of aspirin in women considered high risk by USPSTF criteria vs universal receipt. Hypothesis: Women considered high risk by USPSTF criteria will have better adherence to low dose aspirin than women randomized to universal receipt. Study Design: Randomized trial Population: English or Spanish speaking women between 10-20 weeks of gestation receiving their care at Women & Infants Hospital, with a plan to deliver at Women & Infants Hospital Once enrolled, patients will then be randomized to USPSTF criteria to determine if they qualify for aspirin or to universal aspirin receipt. Once randomized, patients will undergo video pill counts at multiple intervals in their prenatal care (monthly).
Tracking Information
- NCT #
- NCT04797949
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sebastian Z Ramos, MD Women and Infants Hospital
Get Well Soon