Document text
Principal Investigator: Kurt T Barnhart
Organization: UNIVERSITY OF PENNSYLVANIA
Fiscal Year: 2024
Award: $680,699
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
Project Summary
Aspirin is currently recommended during pregnancy to help prevent preeclampsia, and also shows promise for
protecting against pregnancy loss. Preeclampsia is a dangerous complication of pregnancy that puts both the
pregnant person and their baby at risk of serious morbidity and death, and pregnancy loss is the most common
complication of pregnancy estimated to affect 20-30% of all conceptions. Current clinical guidelines from the
U.S. Preventive Services Task Force (USPSTF) recommend the use of daily “baby” aspirin (81 mg), begun at
12 weeks' gestation, to prevent preeclampsia. However, data suggest that even earlier initiation of aspirin and
at higher doses may result in greater protection. Furthermore, initiating aspirin immediately upon pregnancy
recognition may maximize effects on preeclampsia while also providing the added opportunity to prevent
pregnancy loss. Therefore, we propose to conduct a randomized trial to investigate whether daily “double low-
dose” aspirin therapy (162 mg per day) initiated at the time of first positive pregnancy test (up to 6 weeks'
gestation) may help prevent both outcomes. Clinical recruitment of participants through the follow-up of all
initial pregnancy tests throughout the Penn Medicine system will ensure feasibility for early detection of
pregnancy, enabling pregnancy loss monitoring and initiation of the trial intervention. The findings from this
study will provide essential, high-quality evidence in a diverse sample of U.S. pregnant people to inform
potential changes to clinical guidelines for aspirin use in pregnancy. We will (Aim 1) determine the effect of
aspirin treatment (dose 162 mg) initiated upon positive pregnancy test (up to 6 weeks' gestation) compared to
standard of care (dose 81 mg initiated at 12 weeks' gestation) on preeclampsia in a diverse population; (Aim 2)
determine the effect of aspirin treatment (dose 162 mg) initiated upon positive pregnancy test (up to 6 weeks'
gestation) compared to standard of care (dose 81 mg initiated at 12 weeks' gestation) on pregnancy loss in a
diverse population; and (Aim 3) identify phenotypes who may benefit most from “double low-dose” aspirin (162
mg) begun soon after conception, using machine learning, to inform more targeted therapy for optimal overall
pregnancy outcomes. As a safe, affordable intervention, these findings will have immediate translational value
to improve reproductive outcomes in pregnant patients, including minorities such as Black women vastly
underrepresented in current data.
Terms: <1st trimester><Acetylsalicylic Acid><Active Follow-up><Advisory Committees><Affect><Area><Aspirin><Biometrics><Biometry><Biostatistics><Cells Placenta-Tissue><Cessation of life><Clinical><Clinical Trials><Conceptions><Dangerousness><Data><Death><Discipline of obstetrics><Dose><Double-Blind Method><Double-Blind Study><Double-Blinded><Double-Masked Method><Double-Masked Study><EPH Gestosis><Early Diagnosis><Early Placental Phase><Ensure><First Pregnancy Trimester><First Trimester><Gestation><Gestational Hypertension><Guidelines><Gynecologic><Health><Hospitals><Hypertension><Hypertension induced by pregnancy><Hypertension-Associated Pregnancy Disorder><Intervention><Intervention Strategies><Intervention Trial><Interventional trial><Literature><Machine Learning><Medicine><Minority><Miscarriage><Monitor><Morbidity><Morbidity - disease rate><Normal Placentoma><Obstetrics><Outcome><Patient Recruitments><Patients><Pennsylvania><Perinatal><Perinatal Epidemiology><Peripartum><Persons><Phenotype><Philadelphia><Placebos><Placenta><Placenta Embryonic Tissue><Placental Development><Placentation><Placentome><Population><Population Heterogeneity><Pre-Eclampsia><Preeclampsia><Pregnancy><Pregnancy Associated Hypertension><Pregnancy Complications><Pregnancy Outcome><Pregnancy Tests><Pregnancy Toxemias><Pregnancy loss><Preventative service><Prevention><Preventive service><Primary Prevention><Proteinuria-Edema-Hypertension Gestosis><Protocol><Protocols documentation><Randomization trial><Recommendation><Research><Risk><Sampling><Sham Treatment><Shoulder><Spontaneous abortion><System><Task Forces><Time><U.S. Preventative Services Task Force><U.S. Preventative Task Force><U.S. Preventive Services Task Force><U.S. Preventive Task Force><US Preventative Services Task Force><US Preventative Task Force><US Preventive Health Services Task Force><US Preventive Services Task Force><US Preventive Task Force><USPSTF><Underrepresented Ethnic Minority><Underrepresented Minority><United States Preventative Services Task Force><United States Preventative Task Force><United States Preventive Services Task Force><United States Preventive Task Force><Universities><Vascular Hypertensive Disease><Vascular Hypertensive Disorder><Vascularization><Woman><active followup><advisory team><black female><black women><clinical care><complications during pregnancy><diverse populations><dosage><early detection><follow up><follow-up><followed up><followup><heterogeneous population><high blood pressure><hyperpiesia><hyperpiesis><hypertensive disease><hypertensive disease of pregnancy><hypertensive disorder><implantation><improved><interventional strategy><machine based learning><machine learning based method><machine learning method><machine learning methodologies><metropolitan><novel><optimal therapies><optimal treatments><participant recruitment><population diversity><pre-eclamptic><pregnancy disorder><pregnancy hypertension><pregnancy toxemia/hypertension><pregnancy-related complications><pregnant><prevent><preventing><psychologic><psychological><randomized trial><recruit><reproductive><reproductive outcome><secondary outcome><sham therapy><standard of care><targeted drug therapy><targeted drug treatments><targeted therapeutic><targeted therapeutic agents><targeted therapy><targeted treatment><under-representation of minorities><under-represented minority><underrepresentation of minorities>