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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Clinician notification of elevated preeclampsia risk
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Aspirin prescription or medication list entry
Proportion of eligible encounters with aspirin prescribed or documented as an active medication in the electronic health record.
Clinician documentation of aspirin recommendation
Proportion of eligible encounters with clinician documentation recommending aspirin prophylaxis for preeclampsia prevention.
Timing of aspirin prophylaxis implementation
Gestational age at first evidence of aspirin prescription, medication list entry, or documented clinician recommendation.
Other outcomes
Notification actionability / clinician response
Proportion of notifications followed by aspirin prescription, medication list entry, or clinician documentation of aspirin discussion or recommendation.
Sponsors and contacts
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