Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention

NCT07614893 | Not Yet Recruiting DMC

• 1 other identifier: 2023P002133
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia; Hypertensive Disorders of Pregnancy (HDP); Pregnancy Complications; Aspirin Prophylaxis

Keywords

preeclampsia; aspirin prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Aspirin prescription or medication list entry

  From 12 weeks' gestation through 28 weeks' gestation

• Clinician documentation of aspirin recommendation

  From 12 weeks' gestation through 28 weeks' gestation

• Timing of aspirin prophylaxis implementation

  From 12 weeks' gestation through 28 weeks' gestation

Other Outcomes (1)

• Notification actionability / clinician response

  From notification delivery through 28 weeks' gestation

Study Arms (2)

Clinician Notification

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Eligible patient encounters will receive routine outpatient obstetric care without study-generated clinician notification of elevated preeclampsia risk.

Interventions

Clinician notification of elevated preeclampsia risk BEHAVIORAL

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.

Clinician Notification

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Emily Lau, MD, MPH

CONTACT

617-643-6161; elau6@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Clusters of outpatient obstetric clinics, care teams, or clinician groups will be randomized to clinician notification versus usual care. Eligible patient encounters will be assigned according to the randomized cluster to which their obstetric clinician, care team, or clinic is assigned.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (1)