Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention

A Pragmatic Cluster-Randomized Trial of Clinician Notification to Increase Aspirin Prophylaxis Utilization Among Pregnant Individuals at Elevated Risk for Preeclampsia

Preeclampsia is a leading cause of maternal morbidity and mortality. Low-dose aspirin prophylaxis reduces preeclampsia risk among high-risk pregnant individuals but remains underused in routine clinical practice. This pragmatic cluster-randomized implementation trial will test whether clinician notification of elevated preeclampsia risk increases aspirin prophylaxis utilization among eligible pregnant individuals receiving outpatient obstetric care.

Clusters will be randomized to clinician notification versus usual care. In the intervention arm, obstetric clinicians will receive notification that a patient is at elevated risk for preeclampsia and a recommendation to consider initiation of aspirin prophylaxis between 12 and 28 weeks' gestation, as clinically appropriate. The intervention does not assign participants to aspirin and does not require any study-mandated medication. All decisions regarding aspirin prophylaxis will remain at the discretion of the treating obstetric clinician and patient.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Complications; Preeclampsia; Hypertensive Disorders of Pregnancy (HDP); Aspirin Prophylaxis
• Intervention / Treatment: Behavioral: Clinician notification of elevated preeclampsia risk

Detailed Description

This study is a pragmatic, cluster-randomized implementation trial conducted across two medical centers. The trial will evaluate whether clinician notification of elevated preeclampsia risk increases utilization of aspirin prophylaxis among eligible pregnant individuals in routine outpatient obstetric care.

Eligible encounters will include pregnant individuals receiving outpatient obstetric care who are identified as having elevated risk for preeclampsia based on a clinical risk prediction model. Clusters, defined as outpatient obstetric clinics, care teams, or clinician groups, will be randomized to clinician notification or usual care.

For encounters assigned to the intervention arm, clinicians will receive a notification indicating that the patient is at elevated predicted risk for preeclampsia. The notification will recommend consideration of aspirin prophylaxis initiation between 12 and 28 weeks' gestation when clinically appropriate and consistent with applicable clinical guidelines. The notification is intended to support clinician awareness and evidence-based preventive care. It does not mandate aspirin use or assign patients to receive aspirin.

Encounters assigned to usual care will proceed according to existing clinical workflows without study-generated clinician notification. The primary outcome will be aspirin prophylaxis utilization, defined by electronic health record evidence of aspirin prescription, active medication list entry, or documented clinician recommendation during the eligible gestational window.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Lau, MD, MPH; Phone Number: 617-643-6161; Email: elau6@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass General Brigham
      • Contact: Emily Lau, MD, MPH; Phone Number: 617-643-6161; Email: elau6@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant individuals receiving outpatient obstetric care at participating medical centers.
• Age 18 years or older.
• Currently pregnant and within 12 to 28 weeks' gestation
• Identified as having elevated predicted risk for preeclampsia as defined by USPSTSF and ACOG criteria
• Receiving care from a clinician, care team, or clinic participating in the randomized implementation trial.

Exclusion Criteria:

• Known contraindication to aspirin prophylaxis documented in the electronic health record.
• Pregnancy beyond the prespecified gestational age window for aspirin prophylaxis implementation at the time of eligibility assessment.
• Not receiving ongoing obstetric care at a participating site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinician Notification; Obstetric clinicians caring for eligible pregnant individuals will receive a notification indicating elevated preeclampsia risk and recommending consideration of aspirin prophylaxis between 12 and 28 weeks' gestation, as clinically appropriate. Aspirin use will not be mandated by the study.	Behavioral: Clinician notification of elevated preeclampsia risk; A clinician-facing electronic or workflow-based notification identifying elevated predicted preeclampsia risk and recommending consideration of aspirin prophylaxis according to routine clinical care and applicable guidelines.
No Intervention: Usual Care; Eligible patient encounters will receive routine outpatient obstetric care without study-generated clinician notification of elevated preeclampsia risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspirin prophylaxis utilization	Proportion of eligible patient encounters with evidence of aspirin prophylaxis utilization, defined as aspirin prescription, aspirin documented on the medication list, or clinician documentation recommending aspirin prophylaxis during the eligible gestational window.	From 12 weeks' gestation through 28 weeks' gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspirin prescription or medication list entry	Proportion of eligible encounters with aspirin prescribed or documented as an active medication in the electronic health record.	From 12 weeks' gestation through 28 weeks' gestation
Clinician documentation of aspirin recommendation	Proportion of eligible encounters with clinician documentation recommending aspirin prophylaxis for preeclampsia prevention.	From 12 weeks' gestation through 28 weeks' gestation
Timing of aspirin prophylaxis implementation	Gestational age at first evidence of aspirin prescription, medication list entry, or documented clinician recommendation.	From 12 weeks' gestation through 28 weeks' gestation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Notification actionability / clinician response	Proportion of notifications followed by aspirin prescription, medication list entry, or clinician documentation of aspirin discussion or recommendation.	From notification delivery through 28 weeks' gestation

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: preeclampsia; aspirin prophylaxis
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Pregnancy Complications
• Other Study ID Numbers: 2023P002133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No