Aspirin for Pre-eclampsia Prevention

Recruiting in Palo Alto (17 mi)

Overseen byPriyanka Kumar

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Virginia

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.

Eligibility Criteria

This trial is for pregnant women aged 18-50 in their first trimester who may be at low or high risk of developing preeclampsia, as determined by ACOG and FMF tools. Participants must be able to take oral medication, comply with study procedures, and have a prenatal ultrasound between 11+0 through 13+6 days of gestation.

Inclusion Criteria

Provision of signed and dated informed consent form

I am between 18 and 50 years old.

I am pregnant and in my first trimester.

+4 more

Exclusion Criteria

ASA allergy, known hypersensitivity to NSAIDS

Non-viable pregnancy

I have nasal polyps.

+7 more

Participant Groups

The trial is testing the effects of two different daily doses of aspirin (81 mg vs. 162 mg) on preventing preterm preeclampsia in high-risk patients. It's an open-label study where participants are randomly assigned to one of four groups to see if a higher dose has better outcomes.

4Treatment groups

Experimental Treatment

Active Control

Group I: 3 Standard of Care GroupExperimental Treatment1 Intervention

Group 3: These patients will be screened positive for the ACOG screening test but negative for the FMF preeclampsia screen. These women will be offered 81 mg aspirin, which is the standard of care.

Group II: 2 Randomized Group 1Active Control2 Interventions

Group 2: These patients will be screened negative for the ACOG screening test but positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.

Group III: Group 4 Randomized Group 2Active Control2 Interventions

Group 4: These patients will be screened negative for the ACOG screening test and positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.

Group IV: 1 Control GroupActive Control1 Intervention

Control Group (Group 1): These patients will be screened negative for both the ACOG screening test and the FMF preeclampsia screen. These women will receive no aspirin.