Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Adherence to aspirin use
Study Overview
Brief Summary
There are data showing that a majority of pregnant women may not be accurately identified as high risk through screening and therefore, not receiving prophylactic low dose aspirin as recommended. This leads to missing many patients who would benefit from aspirin administration. Aspirin is an effective, affordable and safe intervention and its universal use in pregnancy has been proposed as the answer to help mitigate risk of significant morbidity from preeclampsia. However, adherence to aspirin in women at low risk compared to those deemed at high risk of preeclampsia has never been studied. One of the arguments against universal aspirin administration is the concern that universal receipt would change the compliance in those at high risk although there are no data to support this concern. To address the lack of data on differences in adherence, our goal in this proposal is to assess whether there is a difference in adherence to low dose aspirin (81 mg) in women at high risk of preeclampsia as indicated by USPSTF risk algorithm when compared to those women randomized to universal use.
Detailed 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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The study personnel who will perform pill counts will be masked to the study arm.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnancy between 10 to 20 weeks gestation by best available dating
- •18 years of age or older
- •Fluency in English or Spanish
Exclusion Criteria
- •Contraindication to aspirin use
Arms & Interventions
Randomized to USPSTF Criteria
Women randomized to knowing their risk of preeclampsia and therefore, candidates for low dose aspirin.
Intervention: Low-dose aspirin (Drug)
Randomized to Universal aspirin receipt
Women randomized to receiving low dose aspirin without knowing their risk status.
Intervention: Low-dose aspirin (Drug)
Outcomes
Primary Outcomes
Adherence to aspirin use
Time Frame: up to 42 weeks.
A Research Coordinator will contact each patient within 7 days of recruitment to assure the patient has picked up and has their prescription with subsequent contacts occurring at 30-day intervals until delivery.
Secondary Outcomes
- Rates of postpartum hemorrhage(These will be assessed within 24 hours after delivery.)
- Rates of preeclampsia(Rates of hypertensive disease of pregnancy will be measured from 20 weeks of gestation until 6 weeks postpartum)
- Fetal growth restriction(This will be measured from 24 weeks until 39 weeks.)
- Placental abruption(This will be measured from 20 weeks until 42 weeks.)
Investigators
Sebastian Ramos
Principal Investigator
Women and Infants Hospital of Rhode Island