Low Dose Aspirin Alerts in High-Risk Pregnancies

Last updated: August 14, 2025
Sponsor: Geisinger Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Preeclampsia

Treatment

Electronic health record best practice alert

Clinical Study ID

NCT05802940
LDA BPA
  • Female

Study Summary

The goal of this study is to assess the effect of an electronic health record (EHR) clinical decision support tool, also known as a best practice alert (BPA), on healthcare provider recommendations for low dose aspirin use in a high-risk pregnant patient population. The investigators hypothesize that the implementation of the EHR BPA tool will increase the healthcare provider's recommendation for low dose aspirin compared to current standard care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Receiving prenatal care within Geisinger

  • Initial prenatal visit prior to 28 weeks gestation

  • Determined to be high risk for preeclampsia based on the modified United StatesPreventive Services Task Force and American College of Obstetrics and Gynecologycriteria (at least 1 high risk factor)

Exclusion

Exclusion Criteria:

  • Not pregnant

  • No prenatal visit prior to 28 weeks gestation

  • Maternal-Fetal Medicine only visits

  • Not meeting the modified USPSTF high-risk criteria

  • Contraindication to aspirin, including allergy

Study Design

Total Participants: 640
Treatment Group(s): 1
Primary Treatment: Electronic health record best practice alert
Phase:
Study Start date:
June 19, 2023
Estimated Completion Date:
October 31, 2025

Study Description

Low dose aspirin (LDA) has been found to reduce the incidence of preeclampsia in high-risk pregnant patients. At a health system serving central and northeastern Pennsylvania, electronic health record data reveal that clinicians recommend an LDA regimen to only 60% of eligible high-risk pregnant patients, suggesting the need and opportunity for increased LDA recommendation. This study will assess the efficacy of an electronic health record based clinician-facing interruptive clinical decision support tool/best practice alert (BPA) aimed at increasing LDA recommendation for pregnant patients who are at high risk of preeclampsia.

Up to 704 patients will be randomized to account for possible 10% miscarriage and early termination rate as we require outcome data on a total of 640 patients for adequate power. Eligible patients will be randomized to a control group, where the clinician receives no BPA, and one experimental group, where the provider receives a BPA noting the patient is at high-risk and recommend the provider order LDA. If LDA is not recommended, there will be a required acknowledgment reason from the provider noting a rationale for not initiating a LDA regimen.

Connect with a study center

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

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