What side effects are associated with this type of intervention?

Low-dose aspirin, commonly used for the prophylaxis of preeclampsia, works by inhibiting platelet aggregation. Known side effects include an increased risk of major bleeding events such as gastrointestinal bleeding, intracranial hemorrhage, and subarachnoid hemorrhage. Minor bleeding and gastrointestinal discomfort are also potential side effects.

What prior FDA approvals exist?

Low-dose aspirin is the primary FDA-approved treatment for the prophylaxis of preeclampsia. It works by inhibiting the enzyme cyclooxygenase, leading to decreased formation of thromboxane A2, which is a promoter of platelet aggregation. This mechanism helps reduce the risk of preeclampsia in pregnant women. Other treatments for preeclampsia prophylaxis are not as well established or widely approved by the FDA.

What other types of research exist?

Promising alternatives to low-dose aspirin for the prophylaxis of preeclampsia may include other antiplatelet agents such as low-dose heparin or clopidogrel. Additionally, medications with anti-inflammatory properties, such as certain COX-2 inhibitors, could be considered, although their cardiovascular safety profile needs careful evaluation. It is essential to consult with a healthcare provider to determine the most appropriate prophylactic treatment based on individual risk factors and medical history.

← Back to Search

Antiplatelet agent

Aspirin for Preeclampsia Prevention

Q: What is the mechanism of action of this treatment?

Low-dose aspirin is commonly used for the prophylaxis of preeclampsia due to its ability to inhibit platelet aggregation. It works by irreversibly inhibiting the enzyme cyclooxygenase, which decreases the formation of thromboxane A2, a substance that promotes platelet aggregation. This reduction in platelet aggregation helps to improve blood flow and reduce the risk of developing preeclampsia, a condition characterized by high blood pressure and potential damage to other organ systems. This mechanism is crucial for patients as it helps to mitigate one of the leading causes of pregnancy complications and maternal deaths worldwide.

Phase < 1

Recruiting

Led By Amihai Rottenstreich, MD

Research Sponsored by Rockefeller University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 and 1 hours post single dose 81 mg enteric-coated aspirin

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing low-dose aspirin to prevent preeclampsia in pregnant women, especially Black women who may have higher rates of aspirin failure. Aspirin works by preventing blood clots and improving blood flow in the placenta. Low-dose aspirin has been studied for a long time for its potential to prevent preeclampsia, with mixed results.

Who is the study for?

This trial is for women aged 18-45 who had preeclampsia in a past pregnancy, took low-dose aspirin before the 16th week of their next pregnancy with at least 80% compliance, and did not have significant health issues like bleeding disorders or chronic hypertension. It's not for those currently pregnant or on blood thinners.

What is being tested?

The study looks into why low-dose aspirin sometimes fails to prevent preeclampsia in pregnant women. Researchers are examining genetic factors that might affect how well aspirin works to reduce this risk.

What are the potential side effects?

Aspirin can cause side effects such as stomach pain, heartburn, nausea, and an increased risk of bleeding. In rare cases, it may lead to severe allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 and 1 hours post single dose 81 mg enteric-coated aspirin

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 and 1 hours post single dose 81 mg enteric-coated aspirin

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 and 1 hours post single dose 81 mg enteric-coated aspirin for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention

Secondary study objectives

Platelet response to aspirin as assessed by VerifyNow Aspirin Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units

Platelet response to aspirin as assessed by VerifyNow Base Assay in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units

Platelet response to aspirin as assessed by aggregometry in relation to aspirin success in preeclampsia prevention-measured as VerifyNow Reaction Units

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Women with prior history of preeclampsia who received aspirin in subsequent gestationExperimental Treatment1 Intervention

Single-dose of enteric-coated 81 mg aspirin

Group II: Healthy volunteersActive Control1 Intervention

In this group, no aspirin will be given, as blood draw will not be performed at all among the healthy volunteers. The group of healthy volunteers will serve only for the SNP assay development.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin

2014

Completed Phase 4

~55580

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Low-dose aspirin is commonly used for the prophylaxis of preeclampsia due to its ability to inhibit platelet aggregation. It works by irreversibly inhibiting the enzyme cyclooxygenase, which decreases the formation of thromboxane A2, a substance that promotes platelet aggregation. This reduction in platelet aggregation helps to improve blood flow and reduce the risk of developing preeclampsia, a condition characterized by high blood pressure and potential damage to other organ systems. This mechanism is crucial for patients as it helps to mitigate one of the leading causes of pregnancy complications and maternal deaths worldwide.

Effects of plasma on the platelet antiaggregatory action of prostacyclin in pregnancy.