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NCT07614893Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
22 May 2026
Start date
1 May 2027
Primary completion date
31 May 2028
Lead sponsor
Massachusetts General Hospital
NCT number
NCT07614893

What you commit to

  • Study type: Interventional
  • Planned participants: 1000
  • From 1 May 2027 to the primary completion date, 31 May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Not receiving ongoing obstetric care at a participating site.

Age

  • Pregnancy beyond the prespecified gestational age window for aspirin prophylaxis implementation at the time of eligibility assessment.

Other

  • Known contraindication to aspirin prophylaxis documented in the electronic health record.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mass General Brigham
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.