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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Women will be prescribed 81 mg of aspirin to take daily during pregnancy.
Women and Infants Hospital
Providence, Rhode Island, United States
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.
Time frame: up to 42 weeks.
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.
Time frame: These will be assessed within 24 hours after delivery.
Rates of preeclampsia
We will measure rates of hypertensive disease of pregnancy
Time frame: 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.
Time frame: This will be measured from 24 weeks until 39 weeks.
Placental abruption
Rates of placental abruption will be collected
Time frame: This will be measured from 20 weeks until 42 weeks.
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