Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07614893
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 31, 2027
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2030

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • No Intervention: Usual Care
    Eligible patient encounters will receive routine outpatient obstetric care without study-generated clinician notification of elevated preeclampsia risk.

Primary Outcome Measure

Aspirin prophylaxis utilization [ Time Frame: From 12 weeks' gestation through 28 weeks' gestation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mass General BrighamBostonMassachusetts02114
Emily Lau, MD, MPH
[email protected]
617-643-6161

Find similar trials in Boston, MA

By research site
Mass General Brigham· Boston, MA

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