30 Participants NeededMy employer runs this trial

Aspirin for Preeclampsia

LM
CA
Overseen ByChristina A. Penfield, MD, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: NYU Langone Health
Must be taking: Aspirin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aspirin affects blood cells in pregnant individuals at risk of developing preeclampsia, a condition that can cause high blood pressure during pregnancy. Participants will take a small dose of aspirin twice daily for four weeks. Researchers will then analyze blood samples to understand aspirin's effects during pregnancy. Pregnant individuals less than 17 weeks along and receiving prenatal care at NYU Langone may be suitable candidates, especially if there is a risk of developing preeclampsia. As an Early Phase 1 trial, this research aims to understand aspirin's effects in pregnant individuals, offering participants a chance to contribute to groundbreaking insights.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on antithrombotic or antiplatelet therapy.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that low-dose aspirin is generally safe for pregnant women at risk of preeclampsia. Studies have found that it can lower the risk of developing preeclampsia without major safety concerns. One large study found no significant increase in bleeding problems with daily doses of 150 to 160 mg. Another review of several studies reported a 17% reduction in preeclampsia with low-dose aspirin use.

These findings suggest that the aspirin dose in this trial, 162 mg daily, is likely well-tolerated. Pregnant women in previous studies have taken similar doses without significant side effects. However, consulting a healthcare provider before joining any clinical trial is always important.12345

Why do researchers think this study treatment might be promising for preeclampsia?

Unlike the standard treatments for preeclampsia, which typically involve managing symptoms with medications like antihypertensives and corticosteroids, aspirin is being explored for its potential preventative properties. Aspirin is unique because it targets the underlying inflammation and blood clotting issues associated with preeclampsia, potentially reducing the risk of complications. Researchers are excited about this treatment because it offers a simple, widely available option that could be integrated easily into existing care protocols, potentially benefiting a large number of patients with minimal side effects.

What evidence suggests that aspirin might be an effective treatment for preeclampsia?

Research has shown that low-dose aspirin can lower the risk of preeclampsia, a serious condition during pregnancy. A review of 59 studies found that low-dose aspirin reduced the risk of preeclampsia by 17%. Taking aspirin doses of 75 mg or more, starting early in pregnancy and continuing regularly, proves effective, especially if begun before 16 weeks. Some studies suggest that doses over 100 mg may further reduce the risk of early preeclampsia. In this trial, participants will take 81 mg of aspirin twice daily (162 mg total) for 4 weeks. Overall, aspirin is considered helpful for preventing preeclampsia in pregnant women at risk.23678

Who Is on the Research Team?

CA

Christina A. Penfield, MD, MPH

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for pregnant people aged 18-50 with a single baby, who are at high risk for preeclampsia and get prenatal care at NYU Langone. They must be less than 17 weeks pregnant and not have certain blood disorders, aspirin allergy, or be on other blood-thinning medications.

Inclusion Criteria

Singleton viable gestation
Pregnant patients at high risk of preeclampsia: Patients meeting USPSTF recommendation for aspirin prophylaxis for preeclampsia based on clinical risk factors.
Pregnant people prior to 17 weeks
See 2 more

Exclusion Criteria

Undergoing glucose challenge test (GCT) at time of blood draw
Allergy or intolerance to aspirin
I am currently taking blood thinners or antiplatelet medication.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take 81mg Aspirin orally, twice daily for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aspirin

Trial Overview

The study looks at how taking low-dose aspirin (81mg twice daily) affects platelets in pregnant patients at risk of preeclampsia. Blood samples are taken about four weeks after starting aspirin to see its effects.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Twice daily dosing of AspirinExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

Effectiveness of low-dose aspirin in reducing the risk of ... - PMC

Aspirin 150 mg was introduced before 11 weeks of gestation. The results showed a non-significant reduction in the incidence of preeclampsia.

Prophylactic Aspirin Dose and Preeclampsia

In this large population-based study, we found no difference in either preeclampsia or bleeding complications when comparing 150 to 160 mg and ...

Low-Dose Aspirin Use During Pregnancy

A subsequent Cochrane review, which pooled aggregate data from 59 trials, reported a 17% relative reduction in preeclampsia with low-dose aspirin use 12.

The effectiveness of low-dose aspirin for the prevention of ...

LDA significantly reduces the risk of HDP, EOPE, and preterm birth, particularly when initiated before 16 weeks of gestation.

Effectiveness of Low-Dose Aspirin (75-150 mg) in ...

The analysis reveals a significant reduction in preeclampsia rates among women receiving low-dose aspirin compared to those on placebo. The ...

Low‐Dose Aspirin for Preventing Preeclampsia and Its ... - PMC

The available evidence suggests that LDA is effective in preventing preeclampsia, preterm birth, and IUGR in high‐risk pregnancies without posing a major safety ...

Study Examines The Safety Of Aspirin For Preeclampsia ...

Background Low-dose aspirin (81 mg) is a treatment known to help lower the risk of preeclampsia. However, not everyone who is at higher risk is told to take it.

Aspirin versus Placebo in Pregnancies at High Risk for ...

Preterm preeclampsia occurred in 13 participants (1.6%) in the aspirin group, as compared with 35 (4.3%) in the placebo group (odds ratio in the ...