Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Clinician notification of elevated preeclampsia risk

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators