Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia

Study Overview
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Brief Summary
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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
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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).

Official Title
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Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia

Conditions
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Medication Adherence, Preeclampsia

Intervention / Treatment
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* Drug: Low-dose aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized to receiving aspirin knowing their risk status vs those who are randomized to universal receipt.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Randomized to USPSTF Criteria<br>Women randomized to knowing their risk of preeclampsia and therefore, candidates for low dose aspirin. | Drug: Low-dose aspirin<br>* Women will be prescribed 81 mg of aspirin to take daily during pregnancy.<br>|
| Active Comparator: Randomized to Universal aspirin receipt<br>Women randomized to receiving low dose aspirin without knowing their risk status. | Drug: Low-dose aspirin<br>* Women will be prescribed 81 mg of aspirin to take daily during pregnancy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to aspirin use | 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. | up to 42 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of postpartum hemorrhage | We will collect information at time of delivery of rates of postpartum hemorrhage defined as estimated blood loss of 1000 cc or greater. | These will be assessed within 24 hours after delivery. | 
| Rates of preeclampsia | We will measure rates of hypertensive disease of pregnancy | Rates of hypertensive disease of pregnancy will be measured from 20 weeks of gestation until 6 weeks postpartum | 
| Fetal growth restriction | We will measure rates of fetal growth restriction defined as estimated fetal weight or abdominal circumference <10%ile. | This will be measured from 24 weeks until 39 weeks. | 
| Placental abruption | Rates of placental abruption will be collected | This will be measured from 20 weeks until 42 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, preeclampsia, adherence, pregnancy