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

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

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

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).

Patients are randomized to receiving aspirin knowing their risk status vs those who are randomized to universal receipt.

Women randomized to knowing their risk of preeclampsia and therefore, candidates for low dose aspirin.

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.

We will collect information at time of delivery of rates of postpartum hemorrhage defined as estimated blood loss of 1000 cc or greater.

Rates of hypertensive disease of pregnancy will be measured from 20 weeks of gestation until 6 weeks postpartum

We will measure rates of fetal growth restriction defined as estimated fetal weight or abdominal circumference <10%ile.

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

Ayala NK, Rouse DJ. A Nudge Toward Universal Aspirin for Preeclampsia Prevention. Obstet Gynecol. 2019 Apr;133(4):725-728. doi: 10.1097/AOG.0000000000003167.

Mone F, Mulcahy C, McParland P, Breathnach F, Downey P, McCormack D, Culliton M, Stanton A, Cody F, Morrison JJ, Daly S, Higgins J, Cotter A, Hunter A, Tully EC, Dicker P, Alfirevic Z, Malone FD, McAuliffe FM. Trial of feasibility and acceptability of routine low-dose aspirin versus Early Screening Test indicated aspirin for pre-eclampsia prevention (TEST study): a multicentre randomised controlled trial. BMJ Open. 2018 Jul 28;8(7):e022056. doi: 10.1136/bmjopen-2018-022056.

Shanmugalingam R, Wang X, Motum P, Fulcher I, Lee G, Kumar R, Hennessy A, Makris A. Clinical Influence of Nonadherence With Prophylactic Aspirin in Preventing Preeclampsia in High-Risk Pregnancies: A Multicenter, Prospective, Observational Cohort Study. Hypertension. 2020 Apr;75(4):1125-1132. doi: 10.1161/HYPERTENSIONAHA.119.14107. Epub 2020 Mar 2.

Werner EF, Hauspurg AK, Rouse DJ. A Cost-Benefit Analysis of Low-Dose Aspirin Prophylaxis for the Prevention of Preeclampsia in the United States. Obstet Gynecol. 2015 Dec;126(6):1242-1250. doi: 10.1097/AOG.0000000000001115.

Henderson JT, Whitlock EP, O'Connor E, Senger CA, Thompson JH, Rowland MG. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014 May 20;160(10):695-703. doi: 10.7326/M13-2844.