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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether alerts to pregnancy care providers increase the use of low-dose aspirin to help prevent preeclampsia, a serious pregnancy condition involving high blood pressure. It is for pregnant adults at higher risk who are 12 to 28 weeks pregnant and get care at participating centers. The study does not require aspirin; the patient and care provider decide whether to use it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You get pregnancy care at a participating medical center without staying in the hospital.
  • You are age 18 or older.
  • You are 12 to 28 weeks pregnant.
  • You have a higher predicted risk of preeclampsia based on the medical guidelines used by the study.
  • Your care provider, care team, or clinic is taking part in the study.

Who can't join

  • Your health record lists a medical reason you should not take aspirin to prevent preeclampsia.
  • When checked for eligibility, you are past the study's pregnancy week limit for starting aspirin.
  • You are not getting ongoing pregnancy care at a participating site.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MA