Aspirin for Pre-eclampsia

Overseen By Aleha Aziz, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Columbia University

Must not be taking: Aspirin, Anticoagulants, NSAIDs

Disqualifiers: Nasal polyps, GI bleeding, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if low-dose aspirin can improve blood vessel function and reduce the severity of preeclampsia symptoms after childbirth. Women diagnosed with severe preeclampsia before delivery will receive either aspirin or a placebo for up to three weeks postpartum. Researchers will compare healthy women without preeclampsia to those with the condition to explore differences. This trial suits women diagnosed with severe preeclampsia before delivery who are not using aspirin or blood thinners for other reasons after birth. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use aspirin or certain blood thinners (like Lovenox or heparin) postpartum for other reasons. If you have any allergies to aspirin or similar drugs, you should not participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking a low dose of aspirin (81 mg per day) is generally safe for pregnant women. A study that combined data from 31 different research projects found that low-dose aspirin can help prevent preeclampsia, a condition that can occur during pregnancy. Thus, aspirin is considered safe for pregnant women at risk of developing this condition.

Another review, which included about 30,000 participants, showed that low-dose aspirin slightly reduced the risk of preeclampsia by 2 to 5%. This further supports its safety. While aspirin is approved for other uses, most people tolerate low-dose aspirin well. Some may experience mild side effects like an upset stomach, but serious side effects are rare. Overall, research supports that low-dose aspirin is safe for pregnant women, especially for those at risk of preeclampsia. ^{1 2 3 4 5}

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

Unlike the standard treatments for pre-eclampsia, which often focus on managing symptoms and preventing complications through medications like antihypertensives and magnesium sulfate, the use of low-dose aspirin is unique because it aims to reduce inflammation and improve blood flow. Aspirin works by inhibiting platelet aggregation, potentially minimizing the risk of severe complications associated with pre-eclampsia. Researchers are excited about this approach because it could offer a preventative measure that is simple, cost-effective, and easily accessible, potentially improving outcomes for both mothers and babies.

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

Research has shown that low-dose aspirin can lower the risk of preeclampsia in some high-risk groups. A review of several studies found that aspirin use slightly reduced the chances of developing preeclampsia by about 17% without increasing bleeding problems during pregnancy. While most research focuses on aspirin use during pregnancy, this trial will compare the effects of low-dose aspirin with a placebo after childbirth. The aim is to determine if low-dose aspirin improves blood vessel function, which preeclampsia can affect. ^{2 5 6 7 8}

Who Is on the Research Team?

Aleha Aziz, MD, MPH

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for women over the age of 18 who were diagnosed with severe preeclampsia before giving birth, regardless of whether they had a single or multiple pregnancy and were at least 20 weeks into their pregnancy. It's not open to those who don't meet these criteria.

Inclusion Criteria

You have been diagnosed with severe preeclampsia before giving birth.

You are either pregnant with one baby or multiple babies.

You are at least 20 weeks pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low-dose aspirin (81mg) or placebo daily for up to 3 weeks postpartum

3 weeks

Follow-up

Participants are monitored for changes in endothelial function and blood pressure after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin
• Placebo

Trial Overview The study is testing if taking low-dose aspirin (81mg) daily for three weeks after delivery helps improve blood vessel function and reduces disease severity in women with severe preeclampsia, compared to a placebo.

How Is the Trial Designed?

Group I: Healthy Controls Group Active Control 1 Intervention

Subjects who are healthy volunteers (n = 10) without severe preeclampsia prior to delivery.

Group II: Low-Dose Aspirin (LDA) Intervention Group Active Control 1 Intervention

Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take 81mg of aspirin daily for up to 3 weeks postpartum, starting within 4 days after delivery.

Group III: Placebo Control Group Placebo Group 1 Intervention

Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take placebo oral capsule daily for up to 3 weeks postpartum, starting within 4 days after delivery.

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

A quality improvement project in an academic OB/Gyn practice showed that implementing a standardized approach to aspirin (ASA) prescription significantly increased screening rates for preeclampsia risk from 47% to 99% among new obstetric patients.

Post-intervention, 79% of patients who screened positive received an ASA recommendation, demonstrating that the standardized process is effective and equitable, with no significant differences in recommendations based on race.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging quality improvement to promote health equity: standardization of prenatal aspirin recommendations. Gross, ME., Godecker, A., Hughes, A., et al.[2023]

Low-dose aspirin has been shown to be beneficial in preventing pre-eclampsia in high-risk pregnant women, based on results from four large clinical trials involving over 13,000 participants.

The use of low-dose aspirin is considered safe for mothers and their babies, although its effect on preventing fetal growth retardation is minimal and no significant therapeutic benefits were found.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose aspirin therapy in obstetrics. Wallenburg, HC.[2019]

Low-dose aspirin treatment in pre-eclamptic women resulted in more significant improvements in blood pressure, temperature, edema, and albuminuria compared to conventional therapy, suggesting its efficacy in managing severe pre-eclampsia.

Both treatment groups had similar obstetric progress and perinatal outcomes, indicating that while low-dose aspirin may enhance certain clinical parameters, it does not negatively impact overall pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of severe pre-eclampsia by acetyl salicylic acid. Toppozada, M., Khowessah, M., Shaala, S., et al.[2019]

A systematic review of studies indicates that low-dose aspirin (80-150 mg daily) taken in the first trimester (before 16 weeks) may effectively reduce the severity of preeclampsia in at-risk pregnancies.

In contrast, studies administering aspirin later in pregnancy showed mixed results, suggesting that the timing and dosage of aspirin are crucial for its effectiveness in preventing preeclampsia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Role of Aspirin in Preeclampsia Prevention: State of the Art]. Campos, A.[2018]

In a study of 3,597 patients at risk for preeclampsia, those taking 162 mg of aspirin had a significantly lower rate of preeclampsia (10.1%) compared to those taking the standard 81 mg dose (14.2%).

The higher 162 mg dose did not increase the risk of bleeding complications, suggesting it may be a safer and more effective option for preeclampsia prophylaxis in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Aspirin 162 mg for Preeclampsia Prophylaxis in High-Risk Patients. Ayyash, M., Goyert, G., Garcia, R., et al.[2023]

In a study of 71,627 singleton pregnancies, low-dose aspirin (LDA) was associated with a higher risk of placental abruption (adjusted odds ratio of 1.44) and postpartum hemorrhage (PPH) (adjusted odds ratio of 1.21), suggesting potential safety concerns with its use during pregnancy.

Despite its recommendation for preventing preterm pre-eclampsia, the findings indicate that LDA may not be suitable for all pregnancies, particularly without further research into its bleeding risks, especially in lower-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propensity score analysis of low dose aspirin and bleeding complications in pregnancy. Souter, V., Painter, I., Sitcov, K., et al.[2023]

In a study involving 898 high-risk pregnant women in China, taking 100 mg of low-dose aspirin daily did not significantly reduce the incidence of preeclampsia compared to a control group, with rates of 16.8% in the aspirin group and 17.1% in the control group.

The study also found no significant differences in adverse maternal and neonatal outcomes between the aspirin and control groups, suggesting that low-dose aspirin may not be effective for preeclampsia prevention in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of low-dose aspirin for the prevention of preeclampsia in women at high risk in China. Lin, L., Huai, J., Li, B., et al.[2022]

The CLASP trial indicates that while low-dose aspirin (60 mg per day) is not effective enough to recommend for widespread use in preventing pre-eclampsia, it may help reduce the risk of recurrent early onset pre-eclampsia, particularly in cases starting before 32 weeks' gestation.

Low-dose aspirin is considered safe for both pregnant mothers and their fetuses, making it a potential option for specific high-risk pregnancies, although further research is needed on other supplements like calcium and fish oil for pre-eclampsia prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-eclampsia. III: The role of aspirin in prevention. de Swiet, M.[2013]

A combined multimarker screening strategy in the first trimester can effectively identify 96% of early preterm pre-eclampsia cases and 77% of preterm pre-eclampsia cases, significantly improving detection rates compared to traditional risk factor approaches.

Administering 150 mg of aspirin at bedtime to women identified as high-risk for pre-eclampsia has been shown to significantly reduce the incidence of both preterm and early pre-eclampsia, with minimal adverse effects for mothers and babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-eclampsia screening in the first trimester - preemptive action to prevent the peril. Vikraman, SK., Elayedatt, RA.[2022]

In a study of 164 women with pre-existing diabetes, aspirin did not significantly reduce the risk of pre-eclampsia compared to those not receiving aspirin, suggesting limited efficacy in this specific population.

However, aspirin use was associated with a higher risk of postpartum hemorrhage, indicating a potential safety concern, while early pregnancy HbA1c levels were identified as a useful tool for assessing pre-eclampsia risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin and pre-eclampsia prevention in women with pre-existing diabetes: a retrospective study. Lah, S., Cheung, NW., Lee, V., et al.[2021]

Early initiation of low-dose aspirin (60 mg/day) before 17 weeks of pregnancy significantly reduced the risk of late-onset preeclampsia (≥34 weeks) by 29% in high-risk women, particularly those with chronic hypertension.

The study, which analyzed data from 523 women enrolled in a high-risk trial, found that aspirin led to a 41% reduction in late-onset preeclampsia rates among women with chronic hypertension, supporting the recommendation for early aspirin use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early initiation of low-dose aspirin for reduction in preeclampsia risk in high-risk women: a secondary analysis of the MFMU High-Risk Aspirin Study. Moore, GS., Allshouse, AA., Post, AL., et al.[2018]

Low-dose aspirin can reduce the incidence of pre-eclampsia by about 25%, particularly in high-risk patients, and should ideally be started between 10-14 weeks of pregnancy for maximum effectiveness.

The use of low-dose aspirin is considered safe for both the fetus and neonate, with minimal risk of complications such as abruptio placentae, but further research is needed to optimize treatment strategies and explore combinations with other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacological prevention of pre-eclampsia. Dekker, GA.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12309040/

Effectiveness of low-dose aspirin in reducing the risk ... Aspirin 150 mg was introduced before 11 weeks of gestation. The results showed a non-significant reduction in the incidence of preeclampsia.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211524006006

The effectiveness of low-dose aspirin for the prevention of ... Low-dose aspirin of 162 mg reduces the frequency of preeclampsia. •. Prescribe aspirin between 12 and 20 weeks and stop at 36 weeks gestational age.

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2784499

Aspirin Use to Prevent Preeclampsia and Related ... Evidence demonstrates that aspirin use reduces the risk of preeclampsia in high-risk populations. Timing and Dosage. Effective dosages of low-dose aspirin range ...

4. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2018/07/low-dose-aspirin-use-during-pregnancy

Low-Dose Aspirin Use During Pregnancy A meta-analysis pooling individual patient data from 31 RCTs showed a modest effect of low-dose aspirin prophylaxis on prevention of preeclampsia in groups of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04070573

Low Doses of Aspirin in the Prevention of Preeclampsia Taking ASA (as opposed to placebo) is thought to reduce the risk of preeclampsia by 17%, without increasing the risk of major obstetric bleeding. The number ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12243580/

Randomised controlled trial comparing low doses of ... Our objective is to prospectively compare pregnant patients on 81 mg vs 162 mg of ASA and determine a possible dose response in the prevention of PEC.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11088435/

The optimal dosage of aspirin for preventing preeclampsia in ... The findings demonstrated that aspirin significantly reduced the incidence of preeclampsia (OR = 0.66, 95%CI [0.58, 0.75]), with the best preventive effect ...

8. preeclampsia.org preeclampsia.org/aspirin

Ask About Aspirin The USPSTF review took into account approximately 30,000 randomized subjects, which found a 2 to 5% risk reduction in the rate of preeclampsia.