PreeclampsiaNCT07614893
Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention
A study testing Clinician notification of elevated preeclampsia risk in people with Preeclampsia and Hypertensive Disorders of Pregnancy (HDP), run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Hypertensive Disorders of Pregnancy (HDP), Pregnancy Complications
- What is being tested?
- Clinician notification of elevated preeclampsia risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- May 2027to May 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mass General Brigham
Boston, Massachusetts, 02114
Emily Lau, MD, MPH, 617-643-6161, elau6@mgh.harvard.edu
About this study
Official title: A Pragmatic Cluster-Randomized Trial of Clinician Notification to Increase Aspirin Prophylaxis Utilization Among Pregnant Individuals at Elevated Risk for Preeclampsia
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.
Read the 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.
- Conditions
- Preeclampsia, Hypertensive Disorders of Pregnancy (HDP), Pregnancy Complications, Aspirin Prophylaxis
- Being tested
- Clinician notification of elevated preeclampsia risk
- Keywords
- preeclampsia, aspirin prophylaxis
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician notification of elevated preeclampsia riskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinician Notification | Experimental | 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. Receives: Behavioral: Clinician notification of elevated preeclampsia risk |
| Usual Care | No intervention | Eligible patient encounters will receive routine outpatient obstetric care without study-generated clinician notification of elevated preeclampsia risk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 12 weeks' gestation through 28 weeks' gestation
Secondary outcomes (3)
Aspirin prescription or medication list entry
Proportion of eligible encounters with aspirin prescribed or documented as an active medication in the electronic health record.
Measured: From 12 weeks' gestation through 28 weeks' gestation
Clinician documentation of aspirin recommendation
Proportion of eligible encounters with clinician documentation recommending aspirin prophylaxis for preeclampsia prevention.
Measured: From 12 weeks' gestation through 28 weeks' gestation
Timing of aspirin prophylaxis implementation
Gestational age at first evidence of aspirin prescription, medication list entry, or documented clinician recommendation.
Measured: From 12 weeks' gestation through 28 weeks' gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startMay 2027 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clusters of outpatient obstetric clinics, care teams, or clinician groups will be randomized to clinician notification versus usual care. Eligible patient encounters will be assigned according to the randomized cluster to which their obstetric clinician, care team, or clinic is assigned.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Lau, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614893
- Sponsor's protocol ID
- 2023P002133
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided