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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Clinician NotificationExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
From 12 weeks' gestation through 28 weeks' gestation

Secondary outcomes

1

Aspirin prescription or medication list entry

Proportion of eligible encounters with aspirin prescribed or documented as an active medication in the electronic health record.

Time frame
From 12 weeks' gestation through 28 weeks' gestation
2

Clinician documentation of aspirin recommendation

Proportion of eligible encounters with clinician documentation recommending aspirin prophylaxis for preeclampsia prevention.

Time frame
From 12 weeks' gestation through 28 weeks' gestation
3

Timing of aspirin prophylaxis implementation

Gestational age at first evidence of aspirin prescription, medication list entry, or documented clinician recommendation.

Time frame
From 12 weeks' gestation through 28 weeks' gestation

Other outcomes

1

Notification actionability / clinician response

Proportion of notifications followed by aspirin prescription, medication list entry, or clinician documentation of aspirin discussion or recommendation.

Time frame
From notification delivery through 28 weeks' gestation

Sponsors and contacts

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