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

NCT04797949 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 1581227
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; Preeclampsia

Keywords

aspirin; preeclampsia; adherence; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 42 weeks.

Secondary Outcomes (4)

• Rates of postpartum hemorrhage

  These will be assessed within 24 hours after delivery.

• Rates of preeclampsia

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

• Fetal growth restriction

  This will be measured from 24 weeks until 39 weeks.

• Placental abruption

  This will be measured from 20 weeks until 42 weeks.

Study Arms (2)

Randomized to USPSTF Criteria

ACTIVE COMPARATOR

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

Drug: Low-dose aspirin

Randomized to Universal aspirin receipt

ACTIVE COMPARATOR

Women randomized to receiving low dose aspirin without knowing their risk status.

Drug: Low-dose aspirin

Interventions

Low-dose aspirin DRUG

Women will be prescribed 81 mg of aspirin to take daily during pregnancy.

Randomized to USPSTF Criteria; Randomized to Universal aspirin receipt

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant individuals will be included regardless of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy between 10 to 20 weeks gestation by best available dating
• years of age or older
• Fluency in English or Spanish

You may not qualify if:

• Contraindication to aspirin use

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (5)

• 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.

  PMID: 30870274 RESULT

• 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.

  PMID: 30056389 RESULT

• 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.

  PMID: 32114852 RESULT

• 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.

  PMID: 26551178 RESULT

• 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.

  PMID: 24711050 RESULT

MeSH Terms

Conditions

Medication Adherence; Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sebastian Z Ramos, MD

  Women and Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study personnel who will perform pill counts will be masked to the study arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 15, 2021
• Study Start: March 3, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

US (1)