Clinical trial NCT04797949: Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia
Official title: Adherence to Universal Aspirin Compared to Screening Indicated Aspirin for Prevention of Preeclampsia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Medication Adherence
Preeclampsia
Keywords: aspirin
preeclampsia
adherence
pregnancy
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to receiving aspirin knowing their risk status vs those who are randomized to universal receipt.
Primary purpose: PREVENTION

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to aspirin use
timeFrame: up to 42 weeks.
Secondary outcomes:
measure: Rates of postpartum hemorrhage
timeFrame: These will be assessed within 24 hours after delivery.
measure: Rates of preeclampsia
timeFrame: Rates of hypertensive disease of pregnancy will be measured from 20 weeks of gestation until 6 weeks postpartum
measure: Fetal growth restriction
timeFrame: This will be measured from 24 weeks until 39 weeks.
measure: Placental abruption
timeFrame: This will be measured from 20 weeks until 42 weeks.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital
name: Sebastian Z Ramos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.