Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinician notification of elevated preeclampsia risk.
- Who it may be relevant to
- Registry conditions: Preeclampsia, Hypertensive Disorders of Pregnancy (HDP), Pregnancy Complications, Aspirin Prophylaxis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pragmatic Cluster-Randomized Trial of Clinician Notification to Increase Aspirin Prophylaxis Utilization Among Pregnant Individuals at Elevated Risk for Preeclampsia
Overview
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.
Detailed description
This study is a pragmatic, cluster-randomized implementation trial conducted across two medical centers. The trial will evaluate whether clinician notification of elevated preeclampsia risk increases utilization of aspirin prophylaxis among eligible pregnant individuals in routine outpatient obstetric care.
Eligible encounters will include pregnant individuals receiving outpatient obstetric care who are identified as having elevated risk for preeclampsia based on a clinical risk prediction model. Clusters, defined as outpatient obstetric clinics, care teams, or clinician groups, will be randomized to clinician notification or usual care.
For encounters assigned to the intervention arm, clinicians will receive a notification indicating that the patient is at elevated predicted risk for preeclampsia. The notification will recommend consideration of aspirin prophylaxis initiation between 12 and 28 weeks' gestation when clinically appropriate and consistent with applicable clinical guidelines. The notification is intended to support clinician awareness and evidence-based preventive care. It does not mandate aspirin use or assign patients to receive aspirin.
Encounters assigned to usual care will proceed according to existing clinical workflows without study-generated clinician notification. The primary outcome will be aspirin prophylaxis utilization, defined by electronic health record evidence of aspirin prescription, active medication list entry, or documented clinician recommendation during the eligible gestational window.
Interventions
- Behavioral Clinician notification of elevated preeclampsia risk
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.
Primary outcome measures
- Aspirin prophylaxis utilization [Time frame: From 12 weeks' gestation through 28 weeks' gestation]
Secondary outcome measures (3)
- Aspirin prescription or medication list entry [Time frame: From 12 weeks' gestation through 28 weeks' gestation]
- Clinician documentation of aspirin recommendation [Time frame: From 12 weeks' gestation through 28 weeks' gestation]
- Timing of aspirin prophylaxis implementation [Time frame: From 12 weeks' gestation through 28 weeks' gestation]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Mass General Brigham — Boston
Identifiers
NCT: NCT07614893 · 2023P002133