Aspirin Prophylaxis for Preeclampsia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether informing doctors when a pregnant patient is at high risk for preeclampsia (a pregnancy complication marked by high blood pressure) will increase the use of low-dose aspirin to prevent it. The trial includes two groups: one where doctors receive risk notifications and can decide on aspirin use, and another with regular care without notifications. Pregnant individuals between 12 and 28 weeks who are identified as having a higher risk for preeclampsia might be suitable for this trial.
As an unphased trial, this study allows participants to contribute to important research that could enhance pregnancy care and outcomes.
Do I have to stop taking my current medications for this trial?
The trial does not specify that you need to stop taking your current medications. Decisions about starting aspirin will be made by you and your doctor.
What prior data suggests that clinician notification of elevated preeclampsia risk is safe?
Research has shown that low-dose aspirin can reduce the risk of preeclampsia in pregnant individuals at high risk. Several studies have found that aspirin lowers the chances of developing preeclampsia compared to a placebo. It is recommended for high-risk pregnant women and is generally safe when started between 12 and 28 weeks of pregnancy.
This study focuses on informing doctors about this treatment, not altering the aspirin itself. Since aspirin has been well-studied and approved for this use, much is known about its safety. Most people tolerate low-dose aspirin well, but like any medication, it might not be suitable for everyone. Always consult a healthcare provider to determine if it's appropriate.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to personalize preeclampsia prevention by notifying clinicians of patients' elevated risk. This approach differs from the standard care, which typically involves a blanket recommendation of aspirin for all high-risk pregnancies without such specific alerts. By providing targeted notifications, clinicians can make more informed decisions on whether to recommend aspirin prophylaxis, potentially improving outcomes for both mothers and babies. This personalized method could lead to more efficient use of aspirin and better management of preeclampsia risk.
What evidence suggests that clinician notification is effective for increasing aspirin prophylaxis utilization in preeclampsia?
Research has shown that low-dose aspirin can reduce the risk of preeclampsia in pregnant individuals at high risk. One study found that women taking low-dose aspirin were less likely to develop preterm preeclampsia compared to those on a placebo. Another review also supports using low-dose aspirin for preventing preeclampsia in high-risk cases. Despite this, aspirin remains underutilized in medical practice. This trial includes a "Clinician Notification" arm, where obstetric clinicians receive information about a patient's elevated preeclampsia risk and are encouraged to consider aspirin prophylaxis. By informing doctors of a patient's risk, the trial aims to increase the recommendation of aspirin to prevent preeclampsia.12367
Are You a Good Fit for This Trial?
This trial is for pregnant individuals receiving outpatient obstetric care who may be at higher risk for preeclampsia. There are no specific inclusion or exclusion criteria listed, but participants must be under the care of a clinician during pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Clinicians receive notification of elevated preeclampsia risk and recommendation for aspirin prophylaxis between 12 and 28 weeks' gestation
Follow-up
Participants are monitored for aspirin prophylaxis utilization and clinician response to notifications
What Are the Treatments Tested in This Trial?
Interventions
- Clinician notification of elevated preeclampsia risk
Trial Overview
The study tests whether notifying clinicians when their patients are at high risk for preeclampsia increases the use of low-dose aspirin to prevent it. Clinicians get notifications and recommendations, but starting aspirin remains up to them and their patients.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Obstetric clinicians caring for eligible pregnant individuals will receive a notification indicating elevated preeclampsia risk and recommending consideration of aspirin prophylaxis between 12 and 28 weeks' gestation, as clinically appropriate. Aspirin use will not be mandated by the study.
Eligible patient encounters will receive routine outpatient obstetric care without study-generated clinician notification of elevated preeclampsia risk.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
Aspirin versus Placebo in Pregnancies at High Risk for ...
Treatment with low-dose aspirin in women at high risk for preterm preeclampsia resulted in a lower incidence of this diagnosis than placebo.
Clinician Notification to Increase Aspirin Prophylaxis for ...
Low-dose aspirin prophylaxis reduces preeclampsia risk among high-risk pregnant individuals but remains underused in routine clinical practice.
3.
uspreventiveservicestaskforce.org
uspreventiveservicestaskforce.org/uspstf/recommendation/low-dose-aspirin-use-for-the-prevention-of-morbidity-and-mortality-from-preeclampsia-preventive-medicationAspirin Use to Prevent Preeclampsia and Related ...
The current review included evidence on the effectiveness of low-dose aspirin in preventing preeclampsia in pregnant persons at increased risk ...
Aspirin for preeclampsia prevention in low- and middle ... - PMC
The lack of evidence regarding the effectiveness of aspirin in preventing term preeclampsia is a crucial concern, as 75% of women will develop this subtype of ...
Aspirin Use to Prevent Preeclampsia and Related ...
The current review included evidence on the effectiveness of low-dose aspirin in preventing preeclampsia in pregnant persons at increased risk and in decreasing ...
Low-Dose Aspirin Use During Pregnancy
Low-dose aspirin (81 mg/day) prophylaxis is recommended in women at high risk of preeclampsia and should be initiated between 12 weeks and 28 weeks of gestation ...
The Nationwide Impact of Guidelines for Prophylactic Aspirin ...
aspirin use in high‐risk pregnancies increased from 2.2% to 12.4% in 4 years, Severe preeclampsia slightly decreased from 6.0% to 5.2% after the guideline ...
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