Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia
NCT ID: NCT04797949
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2021-03-03
2022-06-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Randomized to USPSTF Criteria
Women randomized to knowing their risk of preeclampsia and therefore, candidates for low dose aspirin.
Low-dose aspirin
Women will be prescribed 81 mg of aspirin to take daily during pregnancy.
Randomized to Universal aspirin receipt
Women randomized to receiving low dose aspirin without knowing their risk status.
Low-dose aspirin
Women will be prescribed 81 mg of aspirin to take daily during pregnancy.
Interventions
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Low-dose aspirin
Women will be prescribed 81 mg of aspirin to take daily during pregnancy.
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Fluency in English or Spanish
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
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Sebastian Ramos
Principal Investigator
Principal Investigators
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Sebastian Z Ramos, MD
Role: PRINCIPAL_INVESTIGATOR
Women and Infants Hospital
Locations
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Women and Infants Hospital
Providence, Rhode Island, United States
Countries
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References
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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.
Other Identifiers
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1581227
Identifier Type: -
Identifier Source: org_study_id
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